New definition myocardial infarction Circulatory System Myocardial infarction
Conditions
Interventions
Patients will be randomised to receive either:
1. Simvastatin 40 mg, OR
2. Rosuvastatin 10 mg
Please note that the anticipated end date of this trial was extended to the 31st March 2007 following an
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with the following characteristics are eligible for this trial: 1. Within two weeks of new definition Myocardial Infarction (MI) defined as a typical rise of biochemical markers of myocardial necrosis with one or more of the following: 1.1. ischaemic symptoms 1.2. development of pathological Q waves on the Electrocardiogram (ECG) 1.3. ECG changes indicative of ischaemia (ST segment elevation or depression) 1.4. coronary artery intervention (e.g. primary coronary angioplasty) 2. Requiring secondary prevention with a statin in the opinion of the attending clinician 3. Patient must have given written informed consent prior to any trial-specific procedures
Exclusion criteria
Exclusion criteria: Patients with the following characteristics are ineligible for this trial, at the discretion of the attending medical team: 1. Not suitable for statin therapy as determined by the attending clinician 2. Previous statin intolerance 3. Known contra-indication for statin use: 3.1. hypersensitivity to the product 3.2. active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding three times the Upper Limit of Normal (ULN) 3.3. severe renal impairment 3.4. myopathy 3.5. concomitant cyclosporin 3.6. existing polymyositis or dermatomyositis 3.7. pre-disposing factors for myopathy/rhabdomyolysis, which include: moderate renal impairment, hypothyroidism, personal or family history of hereditary muscular disorders, alcohol abuse, situations where an increase in plasma levels may occur, concomitant use of fibrates 4. Already receiving simvastatin 80 mg or atorvastatin 80 mg at time of admission 5. Randomised to the trial during previous admission 6. Aged under 18 years at the time of recruitment 7. Women of childbearing potential not using an effective method of contraception 8. Women who are pregnant or breast-feeding 9. Participation in another pharmacotherapeutic study within the prior 30 days or currently receiving an experimental pharmacological agent 10. Taking drugs associated with rhabdomyolysis in combination with statins (i.e. strong cytochrome P450-3A4 inhibitors such as erythromycin) or other concomitant drugs with special warnings or precautions (as per Summary of Product Characteristics [SPC] for both drugs), for example: fibrates, gemfibrozil, cyclosporin, nicotinic acid, azole antifungals, protease inhibitors, macrolide antibiotics, amiodarone, verapamil, diltiazem or nefazodone 11. Proteinuria ++/+++ 12. Excess alcohol consumption (greater than 50 units per week)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of European lipid targets (Low-Density Lipoprotein [LDL] cholesterol less than 2.5 mmol/l or Total Cholesterol [TC] less than 4.5 mmol/l) at three months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient tolerance: 1.1. Withdrawal from therapy at three months 1.2. Self-reported side-effects at three months 2. Efficacy: 2.1. Comparison of lipid parameters: TC, LDL cholesterol, High-Density Lipoprotein (HDL) cholesterol and triglycerides at three months 2.2. Achievement of National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III (LDL cholesterol less than 100 mg/dl or 2.6 mmol/l) at three months 2.3. Achievement of National Service Framework (NSF) targets (LDL cholesterol less than 3.0 mmol/l or TC less than 5.0 mmol/l) at three months 2.4. Achievement of new UK Joint Society targets (LDL cholesterol less than 2.0 mmol/l or TC less than 4.0 mmol/l) at three months 3. Safety: 3.1. Serious Adverse Events (up to and including three-month follow-up) 3.2. Biochemical markers: Creatine Linase (CK), Alanine aminotransferase (ALT), creatinine and proteinuria 4. Tertiary endpoints: 4.1. Cardiovascular events 4.2. Total mortality as monitored at three months 4.3. Total mortality as monitored indefinitely via Office of National Statistics (extending beyond three-month trial follow-up) | — |
Countries
United Kingdom
Outcome results
None listed