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HOPE TRIAL |
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|---|---|
| Problem | CAD, stroke, PVD or DM |
| Format | Double-blinded multi-center RCT |
| Treatment | Ramipril 10 +/- Vitamin E |
| Control | Placebo |
| Population | 9541 patients |
| Inclusion criteria | 55 years or older History of either: -CAD -Stroke -PVD -DM Plus at least one other CV disease risk factor -Hypertension -Elevated total cholesterole -Elevated LDL -Smoker -Microalbuminuria |
| Exclusion criteria | CCF Ejection fraction < 40% Already taking ACEi or Vitamin E Uncontrolled HTN Overt nephropathy MI or stroke within 4 weeks of study start |
| Follow-up | Mean 5 years |
| Primary endpoint | Composite of death from cardiovascular causes, myocardial infarction, or stroke Each of these outcomes separately |
| Secondary endpoint(s) | Ceath from any cause Need for revascularization, hospitalization for unstable angina or heart failure Complications related to diabetes |
| Details | . |
| Brief summary: | Ramipril prevents new CCF in high risk patients |
| PAPER: Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators. | |
|---|---|
| Date | 20 Jan 2000 |
| Journal | N Engl J Med. 2000 Jan 20;342(3):145-53. |
| Information | Ramipril 10mg vs. placebo -In high-risk patients not known to have CCF/EF <40% -Dose increased over 4 weeks Significantly reduced -Composite of MI/CVA/CV death (14.0->17.8%; RR 0.78, P<0.001) -All above in isolation, and revascularisation and DM complications -New DM diagnoses Drug well tolerated (28.9% permanent discontinuation vs. 27.3 (placebo)) |
| PAPER: Vitamin E Supplementation and Cardiovascular Events in High-Risk Patients | |
|---|---|
| Date | 20 Jan 2000 |
| Journal | N Engl J Med. 2000 Jan 20;342(3):154-60. |
| Information | Vitamin E vs. placebo -No significant different in composite of MI/CVA/CV death -No significant different in any endpoints in isolation No adverse effects |
| PAPER: Prevention of Heart Failure in Patients in the Heart Outcomes Prevention Evaluation (HOPE) Study | |
|---|---|
| Date | 11 Mar 2003 |
| Journal | Circulation. 2003 Mar 11;107(9):1284-90. |
| Information | Ramipril vs. Placebo -Significantly reduced rates of new CCF --Regardless of interim MI -Increased benefit with SBP > 139 mmHg |