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Trial registered on ANZCTR

Registration number

ACTRN12616000535471

Ethics application status

Approved

Date submitted

30/03/2016

Date registered

27/04/2016

Date last updated

27/04/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Long Term Intervention with Pravastatin in Ischaemic Disease

Scientific title

Effect of long term pravastatin treatment on mortality due to coronary heart disease in patients who have suffered a recent acute myocardial infarction or have a diagnosis of unstable angina pectoris.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

LIPID

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Coronary heart disease

Condition category

Condition code

Cardiovascular

Coronary heart disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

20mg pravastatin oral tablet twice daily for 6 years. Dosage will be halved if total cholesterol falls below 3.0 mmol/L on two successive follow-up visits.
Compliance will be assessed by site staff at follow up visits and subjects encouraged to take tablets as directed.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Matching placebo, microcellulose tablet

Control group

Placebo

Outcomes

Primary outcome [1]

Mortality due to coronary heart disease.
Assessed by submission of death certificate and hospital case notes for adjudication by an Outcomes Committee.

Timepoint [1]

6 years. Subsequent assessment by periodic linkage with central death registries to 16 years

Secondary outcome [1]

Mortality due to any cause
Assessed by submission of death certificate and hospital case notes for adjudication by an Outcomes Committee

Timepoint [1]

6 years. Subsequent assessment by periodic linkage with central death registries to 16 years

Secondary outcome [2]

Combined incidence of non-fatal myocardial infarction and fatal coronary heart disease
Assessed by submission of death certificate, hospital case notes, ECGs and laboratory reports for adjudication by an Outcomes Committee

Timepoint [2]

6 years. Subsequent assessment by periodic linkage with central death registries to 16 years

Secondary outcome [3]

Combined incidence of total stroke and non-haemorrhagic stroke
Assessed by submission of hospital case notes and CT or MRI scans for adjudication by a Stroke Assessment Committee

Timepoint [3]

6 years

Secondary outcome [4]

Mortality due to a cardiovascular condition
Assessed by submission of death certificate and hospital case notes for adjudication by an Outcomes Committee

Timepoint [4]

6 years. Subsequent assessment by periodic linkage with central death registries to 16 years

Secondary outcome [5]

Incidence of revascularisation procedures
Assessed by submission of hospital operation report

Timepoint [5]

6 years

Secondary outcome [6]

Total days of hospitalisation
Assessed by dates of hospital admission and discharge entered on Serious Adverse Event forms submitted by study sites

Timepoint [6]

6 years

Secondary outcome [7]

Effects of treatment on total cholesterol using serum samples submitted to a central lipid laboratory.

Timepoint [7]

6 years

Secondary outcome [8]

Effects of treatment on LDL cholesterol using serum samples submitted to a central lipid laboratory.

Timepoint [8]

6 years

Secondary outcome [9]

Effects of treatment on HDL cholesterol using serum samples submitted to a central lipid laboratory.

Timepoint [9]

6 years

Secondary outcome [10]

Effects of treatment on triglycerides using serum samples submitted to a central lipid laboratory.

Timepoint [10]

6 years

Secondary outcome [11]

Effects of treatment on apoprotein A1 using serum samples submitted to a central lipid laboratory.

Timepoint [11]

6 years

Secondary outcome [12]

Effects of treatment on apoprotein B using serum samples submitted to a central lipid laboratory.

Timepoint [12]

6 years

Secondary outcome [13]

Cost-effectiveness of pravastatin treatment assessed by self completed questionnaire designed for this trial: Utility-Based Quality-of-Life Questionnaire (UBQ)

Timepoint [13]

6 years

Secondary outcome [14]

Psychological well-being assessed by self completed questionnaire consisting of:
1. General Health Questionnaire (GHQ)
2. Spielberger Anger Expression Scale
3. Barratt Impulsiveness Scale

Timepoint [14]

6 years

Eligibility

Key inclusion criteria

1. ENTRY DIAGNOSIS:
A. Patients who have suffered an acute myocardial infarction in the period three months to three years prior to screening, where acute myocardial infarction satisfies the following criteria:
1) Discharge diagnosis of acute myocardial infarction in hospital records, OR
2) Any 2 of the following 3:
a. History of typical ischaemic pain lasting for at least 15 minutes and unresponsive to sublingual nitrates
b. Elevation of CK enzymes to more than twice the upper limit of normal
c. Development of new Q-Waves and/or evolutionary ST-T wave changes lasting at least one day.

OR

B. Patients who have been discharged from hospital with a diagnosis of unstable angina pectoris three months to three years prior to assessment, where unstable angina pectoris is defined as definite ischaemic pain increasing in frequency and duration, and/or angina occurring at rest.

2. SERUM CHOLESTEROL:
Total cholesterol between 4.0 and 7.0 mmol/L, measured by the Central Lipid Laboratory in the 4 weeks prior to randomisation

Minimum age

31 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Patients who are unlikely to be available for the duration of follow-up:
i) patients with life threatening illnesses other than coronary artery disease, who are not expected to survive for six years (such as organ transplants), or
ii) those who are unreliable including those with known drug or alcohol related problems.

2. Any cardiac surgery, angioplasty, major surgery or major illness within the past three months.

3. Severely compromised cardiac function (whether due to ischaemic heart disease or not), manifest by either:
i) New York Heart Association (NYHA) Class III or IV congestive heart failure (at the time of assessment).
ii) Left ventricular ejection fraction less than 25% (if measured).

4. History of cerebrovascular disease, including completed stroke or transient ischaemic attack within three months.

5. Significant renal or hepatic disease (such as serum creatinine > 160 micromol/L, serum albumin <3.0 g/dl; bilirubin >30 micromol/L, serum ALT or AST >1.5x the upper limit of normal).

6. Any uncontrolled endocrine disease (particularly if likely to require hospitalisation); chronic pancreatitis; dysproteinaemia; porphyria; systemic lupus erythematosus.

7. Treatment with :
(a) other lipid-lowering agents;
(b) cyclosporin;
(c) other investigational drugs.

8. Known hypersensitivity to HMG-CoA reductase inhibitors or serious adverse reactions from prior administration of HMG-CoA reductase inhibitors.

9. Significant gastrointestinal disease or surgery which might interfere with drug absorption.

10. Women of child-bearing potential (ie pre-menopausal, unless surgically sterilised) and lactating women.

11. Fasting triglyceride (as measured by the Central Lipid Laboratory) of greater than 5mmol/L

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central allocation by phone

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomised block design

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Efficacy

Statistical methods / analysis

From an overview of previous studies, for every 1% reduction in cholesterol there may be expected a 2% reduction in cardiac events and a 1% reduction in deaths due to coronary disease over a five-year period. We may assume a 25% reduction in cholesterol with treatment given optimally. With 80% compliance amongst attenders we should realise around 20% reduction in cholesterol. Hence a 20% reduction in deaths due to coronary heart disease over a five to six year treatment period might be expected. Assuming 80% compliance amongst those taking medication with a 10% drop-out rate and a 10% drop-in rate, a sample size of about 9,000 would be required to detect reliably a reduction in mortality due to coronary heart disease of 25%. This would also provide reasonable statistical power to detect a reduction in total mortality of 20%.
Analysis will be of time to study outcome, with allowance for covariates, using the proportional hazards model, if appropriate.
Potential covariates include age, gender, smoking, other diseases, level of entry lipids, MI/unstable angina, time from MI/angina attack until enrolled.

All analyses will be performed on the groups as originally randomised (ie, the "intention-to-treat" principle). Any subgroup analyses (eg, patients with myocardial infarction versus those with unstable angina) will be performed only on the combined outcome of CHD death and non-fatal myocardial infarction, as this is the only outcome for which there is any reasonable probability of distinguishing reliably between the size of treatment effects in different patient groups.

Three interim analyses are planned at approximately 2, 3, and 4 years after accrual ceases. The events to be used for these analyses will be counts of deaths. The occurrence of serious clinical and adverse events will be kept continuously under surveillance.

Should there be a difference in mortality rate or the incidence rate of major adverse reactions between the treatment groups of at least three standard deviations, then the Safety and Data Monitoring Committee will be informed, so that it may advise the Management Committee appropriately.

The use of this stringent nominal significance level of 0.003 (3 SD) would cover the reasonable number of interim analyses planned and still preserve an overall type I error probability of 0.05.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

1/03/1990

Date of last participant enrolment

Anticipated

Actual

18/12/1992

Date of last data collection

Anticipated

Actual

Sample size

Target

9000

Accrual to date

Final

9014

Recruitment in Australia

Recruitment state(s)

ACT,NSW,QLD,SA,TAS,WA,VIC

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

National Heart Foundation of Australia

Address [1]

PO Box 2
Woden ACT 2606

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Bristol-Myers Squibb Pharmaceuticals

Address [2]

PO Box 39
Noble Park VIC 3174

Country [2]

Australia

Primary sponsor type

University

Name

NHMRC Clinical Trials Centre, The University of Sydney

Address

Locked Bag 77
Camperdown NSW 1450

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Sydney Area Health Service

Ethics committee address [1]

Missenden Road
Camperdown NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/02/1990

Ethics approval number [1]

N/A

Summary

Brief summary

This multicentre, double-blind, placebo-controlled clinical trial is designed to determine whether prolonged reduction in blood cholesterol with pravastatin, one of the class of 3-hydroxy-3-methylglutaryl-coenzyme-A reductase (HMG-CoA reductase) inhibitors, will reduce mortality from coronary heart disease in patients with a history of myocardial infarction or unstable angina pectoris.  To qualify for entry, a patient must have a blood cholesterol level in the range 4.0 to 7.0 mmol/L, and must have suffered a myocardial infarction or have been admitted to hospital with unstable angina, within three months to three years prior to screening.

The primary study outcome will be death due to coronary heart disease. Secondary analyses will be of death from all causes, combined incidence of non fatal myocardial infarction and fatal coronary heart disease, stroke (total and non-haemorrhagic), cardiovascular mortality, coronary revascularisation (CABG and coronary angioplasty), and number of days in hospital during the follow-up period. The goal of intervention is to reduce total blood cholesterol by an average of 25% in patients allocated pravastatin compared with those allocated placebo. To detect reliably the expected effect of such a cholesterol difference on the primary endpoint requires about 9,000 patients be randomised in equal numbers to pravastatin or placebo, and that follow-up of these patients continues for a minimum 5 years for each surviving patient.

Trial website

Trial related presentations / publications

Hague WE, Simes J, Kirby A, Keech AC, White HD, Hunt D, Nestel PJ, Colquhoun DM, Pater H, Stewart RA, Sullivan DR, Thompson PL, West M, Glasziou PP, Tonkin AM. Long-term effectiveness and safety of pravastatin in patients with coronary heart disease: 16 years of follow-up of the LIPID Study. Circulation 2016.

Tonkin AM, Blankenberg S, Kirby A, Zeller T, Colquhoun DM, Funke-Kaiser A, Hague W, Hunt D, Keech AC, Nestel P, Stewart R, Sullivan DR, Thompson PL, West M, White HD, Simes J. Biomarkers in stable coronary heart disease, their modulation and cardiovascular risk: the LIPID biomarker study. International Journal of Cardiology 2015; 201: 499–507.

Funke-Kaiser A, Mann K, Colquhoun D, Zeller T, Hunt D, Simes J, Sullivan D, Sydow K, West M, White H, Blankenberg S, Tonkin AM, on behalf of the LIPID Study Investigators. Midregional proadrenomedullin and its change predicts recurrent major coronary events and heart failure in stable coronary heart disease patients: the LIPID study. International Journal of Cardiology 2014; 172(2): 411–418.

Glasziou PP, Irwig L, Kirby AC, Tonkin AM, Simes RJ. Which lipid measurement should we monitor? An analysis of the LIPID study. BMJ Open 2014; 4(2): e003512.

White HD, Tonkin A, Simes J, Stewart R, Mann K, Thompson P, Colquhoun D, West M, Nestel P, Sullivan D, Keech AC, Hunt D, Blankenberg S, for the LIPID study investigators. Association of contemporary sensitive troponin I levels at baseline and change at 1 year with long-term coronary events following myocardial infarction or unstable angina: results from the LIPID study. Journal of the American College of Cardiology 2014; 63(4): 345–354.

Boekholdt SM, Arsenault BJ, Hovingh GK, Mora S, Pedersen TR, Larosa JC, Welch KM, Amarenco P, Demicco DA, Tonkin AM, Sullivan DR, Kirby A, Colhoun HM, Hitman GA, Betteridge DJ, Durrington PN, Clearfield MB, Downs JR, Gotto AM, Jr., Ridker PM, Kastelein JJ. Levels and changes of HDL cholesterol and apolipoprotein A-I in relation to risk of cardiovascular events among statin-treated patients: a meta-analysis. Circulation 2013; 128(14): 1504–1512.

Nestel PJ, Barnes EH, Tonkin AM, Simes J, Fournier M, White HD, Colquhoun DM, Blankenberg S, Sullivan DR. Plasma lipoprotein(a) concentration predicts future coronary and cardiovascular events in patients with stable coronary heart disease. Arteriosclerosis, Thrombosis & Vascular Biology 2013; 33(12): 2902–2908.

White HD, Simes J, Stewart RA, Blankenberg S, Barnes EH, Marschner IC, Thompson P, West M, Zeller T, Colquhoun DM, Nestel P, Keech AC, Sullivan DR, Hunt D, Tonkin A, for the LIPID Study Investigators. Changes in lipoprotein-associated phospholipase A2 activity predict coronary events and partly account for the treatment effect of pravastatin: results from the Long-term Intervention with Pravastatin in Ischemic Disease study. Journal of the American Heart Association 2013; 2: e000360.

Bell K, Kirby A, Hayen A, Irwig L, Glasziou P. Monitoring adherence to drug treatment by using change in cholesterol concentration: secondary analysis of trial data. BMJ (Clinical Research Ed) 2011; 342: d12.

Cui J, Forbes A, Kirby A, Marschner I, Simes J, Hunt D, West M, Tonkin A. Semi-parametric risk prediction models for recurrent cardiovascular events in the LIPID study. BMC Medical Research Methodology 2010; 10(1): 27.

Cui JF, A; Kirby, A; Simes, J; Tonkin, A. Laboratory and non-laboratory-based risk prediction models for secondary prevention of cardiovascular disease: the LIPID study. European Journal of Cardiovascular Prevention and Rehabilitation 2009; 16(6): 660–668 

Soderberg SC, D; Keech, A; Yallop, J; Barnes, EH; Pollicino, C; Simes, J; Tonkin, AM; Nestel, P. Leptin, but not adiponectin, is a predictor of recurrent cardiovascular events in men: results from the LIPID study. International Journal of Obesity 2009; 33(1): 123-130.

Cui JF, A; Kirby, A; Marschner, I; Simes, J; West, M; Tonkin, A. Parametric conditional frailty models for recurrent cardiovascular events in the LIPID study. Clinical Trials 2008; 5(6): 565–574.

Glasziou PI, L; Heritier, S; Simes, RJ; Tonkin, A; for the LIPID Study Investigators,. Monitoring cholesterol levels: measurement error or true change? Annals of Internal Medicine 2008; 148(9): 656-661.

Stewart RN, FM; Sharples, KJ; Simes, RJ; Tonkin, AM; White, HD; for the LIPID study investigators,. Differences in cardiovascular mortality between Australia and New Zealand according to socioeconomic status: findings from the Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study. New Zealand Medical Journal 2008; 121(1269): 11-23.

West M, Nestel P, Kirby A, Schnabel R, Sullivan D, Simes R, Pollicino C, Lubos E, Munzel T, White H, Tonkin A, Bickel C, Tiret L, Blankenberg S, for the LIPID Study Investigators. The value of N-terminal fragment of brain natriuretic peptide and tissue inhibitor of metalloproteinase-1 levels as predictors of cardiovascular outcome in the LIPID study. European Heart Journal 2008; 29(7): 923-931.

Stocker R, Pollicino C, Gay C, Nestel P, Colquhoun D, Whiting M, Tonkin A, Sullivan D, Simes J. Neither plasma coenzyme Q10 concentration, nor its decline during pravastatin therapy, is linked to recurrent cardiovascular disease events: a prospective case-control study from the LIPID study. Atherosclerosis 2006; 187(1): 198-204.

Tonkin A, Eckermann S, White H, Friedlander D, Glasziou P, Magnus P, Kirby A, Mulray S, Denton M, Sallaberger M, Hunt D, Simes J, on behalf of the LIPID Study Investigators. Cost-effectiveness of cholesterol-lowering therapy with pravastatin in patients with previous acute coronary syndromes aged 65 to 74 years compared with younger patients: results from the LIPID study. American Heart Journal 2006; 151(6): 1305-1312.

Stewart RW, HD; Kirby, AC; Heritier, SR; Simes, RJ; Nestel, PJ; West, MJ; Colquhoun, DM; Tonkin, AM; for the Long-Term Intervention With Pravastatin in Ischemic Disease Study Investigators,. White blood cell count predicts reduction in coronary heart disease mortality with pravastatin. Circulation 2005; 111(14): 1756-1762.

Colquhoun DK, A; Hunt, D; Marschner, I; Simes, J; Glasziou, P; White, H; Barter, P; Tonkin, A; LIPID Study Investigators,. Effects of pravastatin on coronary events in 2073 patients with low levels of both low-density lipoprotein cholesterol and high-density lipoprotein cholesterol: results from the LIPID study. European Heart Journal 2004; 25(9): 771-777.

Hague WF, P; Simes, J; Hunt, D; Tonkin, A. Effect of pravastatin on cardiovascular events and mortality in 1516 women with coronary heart disease: results from the Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) study. American Heart Journal 2003; 145(4): 643-651.

Keech AC, D; Best, J; Kirby, A; Simes, RJ; Hunt, D; Hague, W; Beller, E; Arulchelvam, M; Baker, J; Tonkin, A; for the LIPID study group,. Secondary prevention of cardiovascular events with long-term pravastatin in patients with diabetes or impaired fasting glucose: results from the LIPID trial. Diabetes Care 2003; 26(10): 2713–2721.

Magliano DL, D; Pater, H; Kirby, A; Hunt, D; Simes, J; Sundararajan, V; Tonkin, A. Accuracy of the Australian National Death Index: comparison with adjudicated fatal outcomes among Australian participants in the Long-term Intervention with Pravastatin in Ischaemic Disease (LIPID) study. Australian and New Zealand Journal of Public Health 2003; 27(6): 649-653.

Stewart RN, FM; West, TM; Sharples, KJ; Simes, RJ; Colquhoun, DM; White, HD; Tonkin, AM; for the LIPID Study Investigators,. Depression and cardiovascular morbidity and mortality: cause or consequence? European Heart Journal 2003; 24(22): 2027-2037.

Glasziou P, Eckermann S, Mulray S, Simes R, Martin A, Kirby A, Hall J, Caleo S, White H, Tonkin A. Cholesterol-lowering therapy with pravastatin in patients with average cholesterol levels and established ischaemic heart disease: is it cost-effective? Medical Journal of Australia 2002; 177(8): 428-434.

Hunt D, Young P, Simes J, Hague W, Mann S, Owensby D, Lane G, Tonkin A, for the LIPID study investigators. Benefits of pravastatin on cardiovascular events in older patients with coronary heart disease. Cardiology Review 2002; 19(6): 34.

LIPID Study Investigators, Simes R, Hunt D, Kirby A, Tonkin A, Keech A, Aylward P, Colquhoun D, Glasziou P, Hague W, MacMahon S, Thompson P, West M, White H. Long-term effectiveness and safety of pravastatin in 9014 patients with coronary heart disease and average cholesterol concentrations: the LIPID trial follow-up. Lancet 2002; 359(9315): 1379-1387.

Simes JY, P; Hunt, D. Effects of pravastatin in the elderly [letter]. Annals of Internal Medicine 2002; 136(11): W2.

Simes R, Marschner I, Hunt D, Colquhoun D, Sullivan D, Stewart R, Hague W, Keech A, Thompson P, White H, Shaw J, Tonkin A, on behalf of the LIPID Study Investigators. Relationship between lipid levels and clinical outcomes in the Long-term Intervention with Pravastatin in Ischemic Disease (LIPID) trial: to what extent is the reduction in coronary events with pravastatin explained by on-study lipid levels? Circulation 2002; 105(10): 1162-1169.

West M, White H, Simes R, Kirby A, Watson J, Anderson N, Hankey G, Wonders S, Hunt D, Tonkin A. Risk factors for non-haemorrhagic stroke in patients with coronary heart disease and the effect of lipid-modifying therapy with pravastatin. Journal of Hypertension 2002; 20(12): 2513-2517.

Hunt DY, P; Simes, J; Hague, W; Mann, S; Owensby, D; Lane, G; Tonkin, A; for the LIPID study investigators,. Benefits of pravastatin on cardiovascular events and mortality in older patients with coronary heart disease are equal to or exceed those seen in younger patients: results from the LIPID trial. Annals of Internal Medicine 2001; 134(10): 931-940.

Marschner I, Colquhoun D, Simes R, Glasziou P, Harris P, Singh B, Friedlander D, White H, Thompson P, Tonkin A, on behalf of the LIPID study investigators. Long-term risk stratification for survivors of acute coronary syndromes. Results from the Long-term Intervention with Pravastatin in Ischemic Disease (LIPID) Study. Journal of the American College of Cardiology 2001; 38(1): 56–63.

Reid IR, Hague W, Emberson J, Baker J, Tonkin A, Hunt D, MacMahon S, Sharpe N, on behalf of the LIPID Study Investigators. Effect of pravastatin on frequency of fracture in the LIPID study: secondary analysis of a randomised controlled trial. Long-term Intervention with Pravastatin in Ischaemic Disease. Lancet 2001; 357(9255): 509-512.

Tonkin A, Colquhoun D, Simes J, White H, Hunt D. Pravastatin and coronary heart disease [letter]. Lancet 2001; 357: 1040.

Tonkin A, Colquhoun D, Simes R, White H, Hunt D. Effects of pravastatin in 3260 patients with unstable angina: results from the LIPID study [letter]. Lancet 2001; 357: 1040.

Stewart RS, KJ; North, FM; Menkes, DB; Baker, J; Simes, J. Long-term assessment of psychological well-being in a randomized placebo-controlled trial of cholesterol reduction with pravastatin. The LIPID Study Investigators. Archives of Internal Medicine 2000; 160(20): 3144-3152.

Tonkin A, Colquhoun D, Emberson J, Hague W, Keech A, Lane G, MacMahon S, Shaw J, Simes R, Thompson P, White H, Hunt D, for the LIPID Study Investigators. Effects of pravastatin in 3260 patients with unstable angina: results from the LIPID study. Lancet 2000; 356(9245): 1871-1875.

White H, Simes R, Anderson N, Hankey G, Watson J, Hunt D, Colquhoun D, Glasziou P, MacMahon S, Kirby A, West M, Tonkin A. Pravastatin therapy and the risk of stroke. New England Journal of Medicine 2000; 343(5): 317-326.

White HS, RJ; Anderson, NE; Hankey, GJ; Watson, JD; Hunt, D; Colquhoun, DM; Glasziou, P; MacMahon, S; Kirby, AC; West, MJ; Tonkin, AM. Pravastatin therapy and the risk of stroke [letter]. New England Journal of Medicine 2000; 343: 1894–1896.

LIPID Study Group, Tonkin A, Simes RJ. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. New England Journal of Medicine 1998; 339(19): 1347–1357.

Glasziou P, Simes R, Hall J, Donaldson C. Design of a cost-effectiveness study within a randomized trial: the LIPID trial for secondary prevention of IHD. Long-term Intervention with Pravastatin in Ischemic Heart disease. Controlled Clinical Trials 1997; 18(5): 464-476.

LIPID Management Committee. Lowering cholesterol levels in patients with coronary heart disease. The LIPID Study Management Committee. Medical Journal of Australia 1995; 162(9): 455-456.

LIPID Study Group. Design features and baseline characteristics of the LIPID (Long-term Intervention with Pravastatin in Ischaemic Disease) study: a randomised trial in patients with previous acute myocardial infarction and/or unstable angina pectoris. American Journal of Cardiology 1995; 76(7): 474–479.

Public notes

Contacts

Principal investigator

Name

Prof Andrew Tonkin

Address

Department of Epidemiology and Preventative Medicine
Monash University
99 Commercial Road
Melbourne VIC 3004

Country

Australia

Phone

+61 3 9903 0044

Fax

andrew.tonkin@monash.edu

Contact person for public queries

Name

Helen Pater

Address

NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450

Country

Australia

Phone

+61 2 9562 5000

Fax

enquiry@ctc.usyd.edu.au

Contact person for scientific queries

Name

John Simes

Address

NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450

Country

Australia

Phone

+61 2 9562 5000

Fax

enquiry@ctc.usyd.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Source	Title	Year of Publication	DOI
Embase	Changes in plasma lipids predict pravastatin efficacy in secondary prevention.	2019	https://dx.doi.org/10.1172/jci.insight.128438
Embase	Circulating Cystatin C Is an Independent Risk Marker for Cardiovascular Outcomes, Development of Renal Impairment, and Long-Term Mortality in Patients With Stable Coronary Heart Disease: The LIPID Study.	2022	https://dx.doi.org/10.1161/JAHA.121.020745
Embase	Common genetic variants do not predict recurrent events in coronary heart disease patients.	2022	https://dx.doi.org/10.1186/s12872-022-02520-0
Embase	Distributional regression in clinical trials: treatment effects on parameters other than the mean.	2022	https://dx.doi.org/10.1186/s12874-022-01534-8

N.B. These documents automatically identified may not have been verified by the study sponsor.

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