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Trial registered on ANZCTR


Registration number
ACTRN12615000019505
Ethics application status
Approved
Date submitted
7/11/2014
Date registered
15/01/2015
Date last updated
15/01/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of High Loading Dose of Atorvastatin in ST Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention on Microvascular Perfusion Measured by Index of Microvascular Resistance
Scientific title
Effect of High Loading Dose of Atorvastatin in ST Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention on Microvascular Perfusion Measured by Index of Microvascular Resistance
Secondary ID [1] 285751 0
'None'
Universal Trial Number (UTN)
U1111-1163-5214
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ST Elevation Myocardial Infarction 293410 0
Myocardial Obstruction after Primary PCI 293411 0
Condition category
Condition code
Cardiovascular 293692 293692 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High loading dose of atorvastatin (80 mg) before primary PCI. Atorvastatin was given in oral tablet formulation immediately after patients was diagnosed as STEMI in emergency department and planned to do primary PCI
Intervention code [1] 290531 0
Treatment: Drugs
Comparator / control treatment
Placebo that contain saccharum lactis powder packed in capsule.
Control group
Placebo

Outcomes
Primary outcome [1] 293502 0
Myocardial perfusion measured by index of microcirculatory resistance. Index of microcirculatory resistance measured using a pressure-temperature sensor-tipped wire. It needs maximal hyperemic state that induced by adenosine infusion 140 ug/kg/minutes
Timepoint [1] 293502 0
Immediateley after primary PCI was done (balloning and stenting of the culprit lesion)
Secondary outcome [1] 311182 0
'None'
Timepoint [1] 311182 0
'None'

Eligibility
Key inclusion criteria
ST elevation minimal 0.1 mV in 2 concomittant ECG lead or new or presumably new LBBB
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiogenic shock, respiratory distress, arrythmia, pregnancy

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)
numbered container
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization by randomization table
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
'none'
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
sample size was calculated by formula: mean of 2 independent groups. We used alpha 95%, Zalpha 1.96 and beta 80%, Zbeta 0.84. S1=9, S2=25.2, (X1-X2) = 11.8. After calculation based on formula and above data, minimal sample are 32 samples in each group
statistical analysis: continuous data and categorical data. Bivariate analysis was done by student t test or Mann Whitney for continuous data. Categorical data was analysed by Chi square test or Fischer test

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 6449 0
Indonesia
State/province [1] 6449 0
Jakarta

Funding & Sponsors
Funding source category [1] 290199 0
Self funded/Unfunded
Name [1] 290199 0
Suci Indriani
Address [1] 290199 0
Flamboyan 39, Kota Bambu Utara, Palmerah, Jakarta
Country [1] 290199 0
Indonesia
Primary sponsor type
Individual
Name
Suci Indriani
Address
Departement Cardiology and Vascular Medicine, Faculty of Medicine University of Indonesia. Jl. S. Parman Kav 87, Slipi. Jakarta. Postcode 11420
Country
Indonesia
Secondary sponsor category [1] 289061 0
Individual
Name [1] 289061 0
dr. Doni Firman, SpJP
Address [1] 289061 0
Departement Cardiology and Vascular Medicine, Faculty of Medicine University of Indonesia. Jl. S. Parman Kav 87, Slipi. Jakarta. Postcode 11420
Country [1] 289061 0
Indonesia
Secondary sponsor category [2] 289168 0
Individual
Name [2] 289168 0
dr. Anwar Santoso, SpJP
Address [2] 289168 0
Departement Cardiology and Vascular Medicine, Faculty of Medicine University of Indonesia. Jl. S. Parman Kav 87, Slipi. Jakarta. Postcode 11420
Country [2] 289168 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291910 0
National Cardiovascular Center, Harapan Kita, Jakarta
Ethics committee address [1] 291910 0
jl. S. Parman Kav 87, Jakarta. PO.BOX 11420
Ethics committee country [1] 291910 0
Indonesia
Date submitted for ethics approval [1] 291910 0
01/12/2013
Approval date [1] 291910 0
13/12/2013
Ethics approval number [1] 291910 0

Summary
Brief summary
Background: Statin (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors), given before percutaneous coronary intervention (PCI) was proven to reduce Major Cardiovascular Events (MCE) in patient with stable angina as well as acute coronary syndromes through its pleiotropic effect. Nevertheless, the debate regarding statin administration before primary PCI (PPCI) in STEMI patients is still on the rise. The aim of this study is to establish therapeutic effect of high dose atorvastatin (80 mg) and placebo before primary PCI on microvascular perfusion in STEMI patient using index of microcirculatory resistance (IMR). IMR are specific and quantitative assessment of coronary microvascular dysfunction, reliable on-site predictors of short-term myocardial viability and left ventricle functional recovery of patients undergoing primary PCI for STEMI
Methods: This study is a double blind randomized controlled trial. A high loading dose of atorvastatin (80 mg) or placebo was administered before PPCI. Samples were taken from the population of STEMI patients which underwent PPCI and meet inclusion and exclusion criteria. The primary end point of this study is IMR. After successful primary percutaneous coronary intervention, IMR was measured using a pressure-temperature sensor-tipped coronary guidewire.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52434 0
Dr Suci Indriani
Address 52434 0
Departement Cardiology and Vascular Medicine, Faculty of Medicine University of Indonesia. Jl. S. Parman Kav 87, Slipi. Jakarta. Postcode 11420
Country 52434 0
Indonesia
Phone 52434 0
+62-85214739364
Fax 52434 0
Email 52434 0
suci_fkui02@yahoo.com
Contact person for public queries
Name 52435 0
Dr Suci Indriani
Address 52435 0
Departement Cardiology and Vascular Medicine, Faculty of Medicine University of Indonesia. Jl. S. Parman Kav 87, Slipi. Jakarta. Postcode 11420
Country 52435 0
Indonesia
Phone 52435 0
+62-85214739364
Fax 52435 0
Email 52435 0
oechie.chan18@gmail.com
Contact person for scientific queries
Name 52436 0
Dr Doni Firman, MD
Address 52436 0
Departement Cardiology and Vascular Medicine, Faculty of Medicine University of Indonesia. Jl. S. Parman Kav 87, Slipi. Jakarta. Postcode 11420
Country 52436 0
Indonesia
Phone 52436 0
+6281510369939
Fax 52436 0
Email 52436 0
httpdoni_f@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary