ISRCTN89508434CompletedNot Applicable
Secondary Prevention of Acute Coronary Events. Reduction Of Cholesterol to Key European Targets: an open-label comparative investigation of efficacy, tolerance and health in 2,072 patients randomised to rosuvastatin or 'standard' simvastatin therapy following hospital admission for new definition myocardial infarctio
niversity of Leeds (UK)0 sites2,072 target enrollmentStarted: June 3, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2,072
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
- •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)
Investigators
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