NCT00269243

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 1999

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1999

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
Last Updated

February 8, 2006

Status Verified

December 1, 2005

First QC Date

December 20, 2005

Last Update Submit

February 6, 2006

Conditions

CABG

Interventions

QuinaprilDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post-CABG less than or equal to 7 days (10 days in France)
  • Stable post-operation (as per investigator judgement)
  • Still in hospital
  • years of age or older
  • LVEF ≥40 percent determined within six months before surgery

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Quinapril

Intervention Hierarchy (Ancestors)

TetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jean-Lucien Rouleau, M.D

    Montreal Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 23, 2005

Study Start

November 1, 1999

Study Completion

May 1, 2005

Last Updated

February 8, 2006

Record last verified: 2005-12