Heart Outcomes Prevention Evaluation "HOPE"

Completed

Phase N/A Results

Trial Description

To investigate the efficacy of an ACE inhibitor (ramipril) and vitamin E in improving the long-term outcome of patients at high risk for cardiovascular events.

Interventions

  • Antihypertensives Drug
    Intervention Desc: This category includes all BP lowering drugs in stroke prevention trials
  • Vitamins Drug
    Intervention Desc: Attempt to lower homocysteine by vitamin therapy (folate, B6, B12).

Trial Design

Randomized, multicenter, double-blind, placebo-controlled, three-by-two factorial study

Patient Involvement

All participants received 2.5 mg ramipril for 7-10 days, had their serum creatinine and potassium measured, and then received a 10-14 day course of placebo. They were then randomized to take either 7 days of 2.5 mg ramipril followed by placebo, or 5 mg ramipril for three weeks. After one month, creatinine and potassium were measured again. Any patients who did not comply with or tolerate this regime were removed from the study. The remaining patients continued to receive either 10 mg of ramipril or placebo once daily, while a subgroup was given 2.5 mg ramipril. All patients were randomized to receive either 400 IU vitamin E or a placebo once daily. Patients were evaluated every six months for an average of 4.5 years. Blood pressure was measured at entry to the study, after two years, and at the end of the study.

Outcomes

Type Measure Time Frame Safety Issue
Primary Myocardial infarction, stroke, death due to cardiovascular causes.
Secondary Death from any cause, revascularization procedures, hospitalization for unstable angina or heart failure, complications of diabetes.

Sponsors

Canadian Institutes for Health Research, Aventis, AstraZeneca, King Pharmaceuticals, Natural Source Vitamin E Association, Negma, Heart and Stroke Foundation of Ontario