Acute Coronary Syndrome
Conditions
Brief summary
The purpose of this study is to determine whether a loading dose of atorvastatin before percutaneous intervention procedures in acute coronary syndromes is effective to reduce major cardiovascular events(MACE).
Detailed description
Background: Strategies to reduce complications in acute coronary syndrome treatment have been largely studied. Due to its pleiotropic effects statins are considered an important tool on atherosclerotic plaque stability. Although, the usage of statins before percutaneous coronary intervention in acute coronary syndrome patients, has not yet been demonstrated. Objectives: Evaluate if a loading dose of atorvastatin (80mg) before percutaneous coronary intervention in acute coronary syndrome patients, followed by a reload dose 24 hours, is able to reduce major cardiovascular events (MACE); including combined outcomes such as all-cause mortality, nonfatal acute myocardial infarction, stroke or revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting after 30 days. Methods: Multicentric randomised controlled clinical trial, with allocation concealment and intention to treat analysis. Competitive recruitment will involve 4,192 patients. Acute coronary syndrome patients intending to undergo percutaneous coronary intervention with or without stent placement will be randomized 1:1 to receive either atorvastatin 80mg or placebo before the coronary procedure and also a reload dosage after 24 hours from angioplasty. All patients will collect blood sample to determine CKMB levels pre and post procedure (6 to 12h and 18 to 24 hours). After 30 days, an in person interview will be performed and blood sample will be collected in order to dosage AST, ALT, CPK, and cholesterol levels. Telephonic interview will be done at 6 and 12 months to access occurrence of cardiovascular events.
Interventions
DRUGAtorvastatin
Atorvastatin loading dose of 80mg before PCI, reloading dose of 80mg 24 hours after PCI, and atorvastatin 40mg for 30 days
DRUGPlacebo
Matching placebo before PCI and 24 hours after PCI. Atorvastatin 40mg for 30 days
Sponsors
Ministry of Health, Brazil
Hospital do Coracao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute coronary syndrome patients intending to undergo percutaneous coronary intervention.
Exclusion criteria
* Younger than 18 years * Presence of any contraindication to statin (Pregnant women, breast-feeding women or statin hypersensibility) * Advanced hepatic disease * Use of statins at the maximum dosage in the last 24 hours before the loading dose of the study drug * Use of fibrate in the last 24 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Cardiovascular Events (MACE) | 30 days | All-cause mortality, nonfatal acute myocardial infarction, stroke or revascularization with either percutaneous coronary intervention or coronary artery bypass grafting |
Secondary
| Measure | Time frame |
|---|---|
| Non-fatal Myocardial Infarction | 30 days, 6 months and 12 months |
| Non-fatal Stroke | 30 days, 6 months and 12 months |
| Revascularization | 30 days, 6 months and 12 months |
| Cardiovascular death | 30 days, 6 months and 12 months |
| All-cause mortality | 30 days, 6 months and 12 months |
| Target vessel revascularization | 30 days, 6 months and 12 months |
| Rhabdomyolysis | 7 days or at hospital discharge |
| Bleeding episode | 7 days or hospital discharge |
| Major Cardiovascular Events (MACE) | 6 months and 12 months |
| Stent Thrombosis | 30 days, 6 months and 12 months |
Countries
Brazil
Outcome results
None listed