From: Changes to aspects of ongoing randomised controlled trials with fixed designs
Type of decision | Decision options |
---|---|
Choice of endpoint | 1. Coronary heart disease (CHD) deatha 2. Revascularisation 3. All-cause mortality |
Analysis set composition | 1. No exclusions (i.e. all randomised patients)a 2. Exclude patients with eGFR < 45 (Stage 3a kidney disease or worse) (excludes 4%) 3. Exclude patients with qualifying events within 9 months of randomisation (excludes 29%) |
Covariate specification | 1. Nonea 2. Stroke (2 levels: yes, no) 3. Smoking status (2 levels: never smoked, current/ex-smoker) 4. Index ACS (3 levels: unstable angina pectoris (UAP), single myocardial infarction (MI), multiple MI) 5. Stroke and smoke 6. Stroke and index ACS 7. Smoke and index ACS 8. Stroke, smoke and index ACS |