Management With Accupril Post Bypass Graft

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Angiotensin converting enzyme (ACE) inhibitors have been shown to improve survival and to reduce the risk of cardiovascular events in some groups of patients following myocardial infarction. This study is designed to test whether early initiation (≤7 days) of an ACE inhibitor post-coronary artery bypass graft (CABG), would reduce cardiovascular events. The trial was a double-blind, placebo controlled study of 2,553 patients randomly assigned to quinapril, target dose 40 mg daily or placebo, followed up to 43 months.

• Phase: Phase 4

Details

• Lead Sponsor: Montreal Heart Institute
• Collaborator: Pfizer
• Treatments: Quinapril

Criteria

Inclusion Criteria:

• Post-CABG less than or equal to 7 days (10 days in France)

• Stable post-operation (as per investigator judgement)

• Still in hospital

• 18 years of age or older

• LVEF ≥40 percent determined within six months before surgery

Exclusion Criteria:

• Intolerance/contraindication to ACE-inhibitor or history of angioedema

• Insulin-dependent diabetes, or type II diabetes with microalbuminuria

• Clinical need for an ACE inhibitor or an angiotensin receptor blocker (investigators' judgement)

• Current need for post-CABG urgent intervention

• Valve replacement, not repair, during index CABG

• Significant valve stenosis or cardiomyopathy

• Serum potassium concentration of 5.6 mmol per liter or more

• Primary hyperaldosteronism

• Serum creatinine greater than 2.26 mg per decilitre (suspected renal artery stenosis, single kidney or renal transplant

• Serious concomitant disease, such as cancer, AIDS, sepsis

• SBP >160 mm Hg or DBP <90 mm Hg despite treatment

• SBP <100 mm Hg

• Significant peri-operative myocardial infarction

• Pregnancy, breastfeeding, inadequate contraception

• Investigational drug use <30 days

• Drug, alcohol abuse, inability to adhere to protocol.