MRC / BHF Heart Protection Study "HPS"

Completed

Phase N/A Results

Trial Description

To assess reliably the effects on mortality and major morbidity of cholesterol-lowering therapy and of antioxidant vitamin supplementation in a wide range of different categories of high-risk patients.

Interventions

  • Simvastatin Drug
    Intervention Desc: HMG-CoA reductase inhibitor; lowers cholesterol

Trial Design

Randomized 2x2 study design, with 20536 patients, including over 3000 with TIA, and nearly 7000 with minor ischemic stroke or other peripheral vascular disease.

Patient Involvement

Patients are randomly allocated to receive simvastatin (40 mg daily) or matching placebo tablets and, in a '2x2 factorial' design, antioxidant vitamins (600 mg vitamin E, 250 mg vitamin C and 20 mg beta-carotene daily) or matching placebo capsules. Follow-up visits after randomization are scheduled at 4, 8 and 12 months, and then 6-monthly, for at least 5 years.

Outcomes

Type Measure Time Frame Safety Issue
No outcomes associated with this trial.

Sponsors

UK Medical Research Council, British Heart Foundation, Merck Sharp & Dohme, and Hoffman-LaRoche