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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00991029




Registration number
NCT00991029
Ethics application status
Date submitted
6/10/2009
Date registered
7/10/2009
Date last updated
4/12/2018

Titles & IDs
Public title
Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
Scientific title
Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
Secondary ID [1] 0 0
1U01S062835-01A1
Universal Trial Number (UTN)
Trial acronym
POINT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Attack, Transient 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Clopidogrel
Treatment: Drugs - placebo

Active Comparator: clopidogrel - Patients assigned to clopidogrel in addition to aspirin

Placebo Comparator: placebo - Patients assigned to placebo in addition to aspirin


Treatment: Drugs: Clopidogrel
Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days

Treatment: Drugs: placebo
Loading dose of 8 tablets followed by one tablet daily for 89 days

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes - Primary efficacy outcome: Number of Participants with Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes
Timepoint [1] 0 0
Up to 90 days
Primary outcome [2] 0 0
Major Hemorrhage - Primary safety outcome: Number of Participants with major hemorrhage
Timepoint [2] 0 0
Up to 90 days
Secondary outcome [1] 0 0
Ischemic Stroke - Secondary efficacy outcome:Number of participants with Ischemic stroke
Timepoint [1] 0 0
Up to 90 days
Secondary outcome [2] 0 0
Myocardial Infarction - Secondary efficacy outcome: Number of participants with Myocardial infarction
Timepoint [2] 0 0
Up to 90 days
Secondary outcome [3] 0 0
Death From Ischemic Vascular Causes - Secondary efficacy outcome: Number of participants with Death from ischemic vascular causes
Timepoint [3] 0 0
Up to 90 days
Secondary outcome [4] 0 0
Ischemic or Hemorrhagic Stroke - Secondary efficacy outcome: Number of participants with Ischemic or hemorrhagic stroke
Timepoint [4] 0 0
Up to 90 days
Secondary outcome [5] 0 0
Composite of Ischemic Stroke, Myocardial Infarction, Death From Ischemic Vascular Causes, or Major Hemorrhage - Secondary efficacy outcome: Number of participants with ischemic stroke, myocardial infarction, death from ischemic vascular causes, or major hemorrhage
Timepoint [5] 0 0
Up to 90 days

Eligibility
Key inclusion criteria
- Neurological deficit (based on history or exam) attributed to focal brain ischemia and
EITHER:

- High risk TIA: Complete resolution of the deficit at the time of randomization
AND ABCD2 score of (greater than or equal to) 4 OR

- Minor ischemic stroke: residual deficit with NIHSS of (less than or equal to) 3
at the time of randomization

- Ability to randomize within 12 hours of time last known free of new ischemic symptoms.

- Head CT or MRI ruling out hemorrhage or other pathology, such as vascular
malformation, tumor, or abscess, that could explain symptoms or contraindicate
therapy.

- Ability to tolerate aspirin at a does of 50-325 mg/day.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Age <18 years

- TIA symptoms limited to isolated numbness, isolated visual changes, or isolated
dizziness/vertigo.

- In the judgment of the treating physician, a candidate for thrombolysis,
endarterectomy or endovascular intervention, unless the subject declines both
endarterectomy and endovascular intervention at the time of evaluation for
eligibility.

- Receipt of any intravenous or intra-arterial thrombolysis within 1 week prior to index
event.

- Gastrointestinal bleed or major surgery within 3 months prior to index event.

- History of nontraumatic intracranial hemorrhage.

- Clear indication for anticoagulation (e.g., warfarin, heparin) anticipated during the
study period (atrial fibrillation, mechanical heart valve, deep venous thrombosis,
pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state).

- Qualifying ischemic event induced by angiography or surgery.

- Severe non-cardiovascular comorbidity with life expectancy <3 months.

- Contraindication to clopidogrel or aspirin.

- Known allergy

- Severe renal (serum creatinine >2 mg/dL or 176.8umol/L) or hepatic insufficiency
(prior or concurrent diagnosis, with International Normalized Ratio (INR)>1.5 or
any resultant complication, such as variceal bleeding, encephalopathy, or
icterus)

- Hemostatic disorder or systemic bleeding in the past 3 months

- Current thrombocytopenia (platelet count <100 x10^9/l) or neutropenia (<1
x10^9/l)

- History of drug-induced hematologic or hepatic abnormalities

- Anticipated requirement for long-term (>7 day) non-study antiplatelet drugs (eg,
dipyridamole, clopidogrel, ticlopidine), or Non-steroidal Anti-inflammatory Drugs
(NSAIDs) affecting platelet function (such as prior vascular stent or arthritis).

- Inability to swallow medications.

- At risk for pregnancy: premenopausal or post menopausal woman within 12 months of last
menses without a negative pregnancy test or not committing to adequate birth control
(e.g., oral contraceptive, two methods of barrier birth control, or abstinence).

- Unavailability for follow-up.

- Signed and dated informed consent not obtained from patient.

- Other neurological conditions that would complicate assessment of outcomes during
follow-up.

- Ongoing treatment in another study of an investigational therapy that may potentially
interact with study drug, or treatment in such a study within the last 7 days.

- Previously enrolled in the POINT study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Gosford Hospital - Gosford
Recruitment hospital [2] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [5] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [6] 0 0
The Northern Hospital - Epping
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Footscray Hospital - Footscray
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Austin Hospital - Heidelberg
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Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
- Gosford
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- New Lambton
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- Adelaide
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- Box Hill
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- Clayton
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- Epping
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- Footscray
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- Heidelberg
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- Parkville
Recruitment outside Australia
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Arizona
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California
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Missouri
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New Hampshire
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West Virginia
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France
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Bron
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France
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Paris
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France
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Germany
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Baden-Württemberg
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Germany
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Bad Neustadt an der Saale
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Germany
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Berlin
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Germany
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Essen
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Hannover
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Kiel
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Leipzig
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Munster
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Hidalgo
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Sinaloa
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Mexico
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Mexico City
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Auckland
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Barcelona
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Bilbao
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Burgos
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Donostia
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Girona
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Valencia
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Spain
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Zaragoza
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Cambridge
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Glasgow
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Harrow
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London
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Luton
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Oxford
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Somerset
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Southampton
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United Kingdom
State/province [77] 0 0
Stoke-on-Trent

Funding & Sponsors
Primary sponsor type
Other
Name
University of California, San Francisco
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Neurological Emergencies Treatment Trials Network (NETT)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Medical University of South Carolina
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
The Emmes Company, LLC
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused
by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic
stroke is a cerebral infarction. In POINT, eligibility is limited to brain TIAs and to minor
ischemic strokes (with an NIH Stroke Scale [NIHSS] score less than or equal to 3).

TIAs are common [25], and are often harbingers of disabling strokes. Approximately
250,000-350,000 TIAs are diagnosed each year in the US. Given median survival of more than 8
years [32], there are approximately 2.4 million TIA survivors. In a national survey, one in
fifteen of those over 65 years old reported a history of TIA [33], which is equivalent to a
prevalence of 2.3 million in older Americans. Based on the prevalence of undiagnosed
transient neurological events, the true incidence of TIA may be twice as high as the rates of
diagnosis [33]. Based on our review of the National Inpatient Sample for 1997-2003, there
were an average of 200,000 hospital admissions for TIA each year, with annual charges
climbing quickly in the period to $2.6 billion in 2003.

Composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or
ischemic vascular death at 90 days.
Trial website
https://clinicaltrials.gov/show/NCT00991029
Trial related presentations / publications
Ovbiagele B. Antiplatelet therapy in management of transient ischemic attack: overview and evidence-based rationale. J Emerg Med. 2008 May;34(4):389-96. doi: 10.1016/j.jemermed.2007.08.056. Epub 2008 Jan 18. Review.
Giles MF, Rothwell PM. Risk of stroke early after transient ischaemic attack: a systematic review and meta-analysis. Lancet Neurol. 2007 Dec;6(12):1063-72. Epub 2007 Nov 13. Review.
Kernan WN, Schindler JL. Rapid intervention for TIA: a new standard emerges. Lancet Neurol. 2007 Nov;6(11):940-1.
Rothwell PM. Transient ischaemic attacks: time to wake up. Heart. 2007 Aug;93(8):893-4.
Streifler JY. Early stroke risk after a transient ischemic attack: can it be minimized? Stroke. 2008 Jun;39(6):1655-6. doi: 10.1161/STROKEAHA.107.510248. Epub 2008 Mar 27.
Dean N, Shuaib A. Transient ischaemic attacks: unstable, treatable, neglected. Lancet. 2007 Oct 20;370(9596):1398-400.
Kennedy J, Hill MD, Ryckborst KJ, Eliasziw M, Demchuk AM, Buchan AM; FASTER Investigators. Fast assessment of stroke and transient ischaemic attack to prevent early recurrence (FASTER): a randomised controlled pilot trial. Lancet Neurol. 2007 Nov;6(11):961-9. Epub 2007 Oct 10.
Geisler T, Zürn C, Paterok M, Göhring-Frischholz K, Bigalke B, Stellos K, Seizer P, Kraemer BF, Dippon J, May AE, Herdeg C, Gawaz M. Statins do not adversely affect post-interventional residual platelet aggregation and outcomes in patients undergoing coronary stenting treated by dual antiplatelet therapy. Eur Heart J. 2008 Jul;29(13):1635-43. doi: 10.1093/eurheartj/ehn212. Epub 2008 May 24.
Lotfi A, Schweiger MJ, Giugliano GR, Murphy SA, Cannon CP; TIMI 22 Investigators. High-dose atorvastatin does not negatively influence clinical outcomes among clopidogrel treated acute coronary syndrome patients--a Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) analysis. Am Heart J. 2008 May;155(5):954-8. doi: 10.1016/j.ahj.2007.12.009. Epub 2008 Feb 19.
Mitsios JV, Papathanasiou AI, Rodis FI, Elisaf M, Goudevenos JA, Tselepis AD. Atorvastatin does not affect the antiplatelet potency of clopidogrel when it is administered concomitantly for 5 weeks in patients with acute coronary syndromes. Circulation. 2004 Mar 23;109(11):1335-8. Epub 2004 Mar 15.
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Saw J, Brennan DM, Steinhubl SR, Bhatt DL, Mak KH, Fox K, Topol EJ; CHARISMA Investigators. Lack of evidence of a clopidogrel-statin interaction in the CHARISMA trial. J Am Coll Cardiol. 2007 Jul 24;50(4):291-5. Epub 2007 Jul 10.
Saw J, Steinhubl SR, Berger PB, Kereiakes DJ, Serebruany VL, Brennan D, Topol EJ; Clopidogrel for the Reduction of Events During Observation Investigators. Lack of adverse clopidogrel-atorvastatin clinical interaction from secondary analysis of a randomized, placebo-controlled clopidogrel trial. Circulation. 2003 Aug 26;108(8):921-4. Epub 2003 Aug 18.
Trenk D, Hochholzer W, Frundi D, Stratz C, Valina CM, Bestehorn HP, Büttner HJ, Neumann FJ. Impact of cytochrome P450 3A4-metabolized statins on the antiplatelet effect of a 600-mg loading dose clopidogrel and on clinical outcome in patients undergoing elective coronary stent placement. Thromb Haemost. 2008 Jan;99(1):174-81. doi: 10.1160/TH07-08-0503.
Johnston SC, Gress DR, Browner WS, Sidney S. Short-term prognosis after emergency department diagnosis of TIA. JAMA. 2000 Dec 13;284(22):2901-6.
Coutts SB, Eliasziw M, Hill MD, Scott JN, Subramaniam S, Buchan AM, Demchuk AM; VISION study group. An improved scoring system for identifying patients at high early risk of stroke and functional impairment after an acute transient ischemic attack or minor stroke. Int J Stroke. 2008 Feb;3(1):3-10. doi: 10.1111/j.1747-4949.2008.00182.x.
Coutts SB, Simon JE, Eliasziw M, Sohn CH, Hill MD, Barber PA, Palumbo V, Kennedy J, Roy J, Gagnon A, Scott JN, Buchan AM, Demchuk AM. Triaging transient ischemic attack and minor stroke patients using acute magnetic resonance imaging. Ann Neurol. 2005 Jun;57(6):848-54.
Algra A, van Gijn J, Halkes PH, Kappelle LJ, Koudstaal PJ; ESPRIT Study Group. Interpretation of ESPRIT in the FASTER trial. Lancet Neurol. 2008 Mar;7(3):198-9; author reply 199. doi: 10.1016/S1474-4422(08)70030-9.
Lavallée PC, Meseguer E, Abboud H, Cabrejo L, Olivot JM, Simon O, Mazighi M, Nifle C, Niclot P, Lapergue B, Klein IF, Brochet E, Steg PG, Lesèche G, Labreuche J, Touboul PJ, Amarenco P. A transient ischaemic attack clinic with round-the-clock access (SOS-TIA): feasibility and effects. Lancet Neurol. 2007 Nov;6(11):953-60.
Luengo-Fernandez R, Gray AM, Rothwell PM. Effect of urgent treatment for transient ischaemic attack and minor stroke on disability and hospital costs (EXPRESS study): a prospective population-based sequential comparison. Lancet Neurol. 2009 Mar;8(3):235-43. doi: 10.1016/S1474-4422(09)70019-5. Epub 2009 Feb 4.
Yusuf S, Diener HC, Sacco RL, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlöf B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, VanderMaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Telmisartan to prevent recurrent stroke and cardiovascular events. N Engl J Med. 2008 Sep 18;359(12):1225-37. doi: 10.1056/NEJMoa0804593. Epub 2008 Aug 27.
Sacco RL, Diener HC, Yusuf S, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlöf B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, Vandermaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke. N Engl J Med. 2008 Sep 18;359(12):1238-51. doi: 10.1056/NEJMoa0805002. Epub 2008 Aug 27.
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Public notes

Contacts
Principal investigator
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S. Claiborne Johnston, MD, PhD
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University of Texas, Austin
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Contact person for public queries
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Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00991029