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Outcomes of Angiotensin Converting Enzyme Inhibitor Management Strategies Prior to Coronary Artery Bypass

NCT02096406 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2018-03-22

No results posted yet for this study

Summary

Coronary artery disease is a leading cause of death, hospitalization, and health care costs in developed nations. Coronary revascularization with coronary artery bypass graft (CABG) surgery improves the long term survival in patients with diabetes and multi-vessel disease. Angiotensin converting enzyme inhibitors (ACE) and angiotensin receptor blockers (ARB) reduce mortality and subsequent cardiac events in patients with coronary artery disease undergoing CABG surgery when initiated at least 4 weeks pre-operatively. Observational data have suggested that pre-operative ACE administration is associated with an increased risk of post-operative vasoplegic shock, acute kidney injury, and mortality; however, other studies have failed to confirm these findings and further suggested ACE are associated with a reduced risk of peri-operative myocardial infarction. A single trial of 40 CABG patients randomized to pre-operative ACE withdrawal or continuation reported that the withdrawal group required significantly fewer vasopressors during cardiopulmonary bypass but more intravenous vasodilators post-operatively to control hypertension. Hence, it remains unclear whether ACEs should be held or continued immediately prior to CABG surgery and a survey of cardiac surgeons suggests that current clinical practice is divided. This pilot study aims to establish the feasibility of the study design and to determine the frequency of clinical endpoints among patients who continue and discontinue ACE prior to cardiac surgery.

Conditions

Interventions

DRUG

ACE/ARB continuation

ACE/ARB will be taken the morning of surgery with a sip of water

DRUG

ACE/ARB withdrawal

ACE/ARB will be stopped 48 hours prior to surgery

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Sean van Diepen, MD, Msc · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02096406 on ClinicalTrials.gov