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Clinical Trials/NCT02096406
NCT02096406
Completed
Phase 2

COMParison of Angiotensin Converting Enzyme Inhibitor managemenT Strategies Prior to Coronary Artery Bypass Surgery (the COMPACT Trial): a Pilot Randomized Controlled Registry Study

University of Alberta1 site in 1 country126 target enrollmentApril 2014

Overview

Phase
Phase 2
Intervention
ACE/ARB continuation
Conditions
Coronary Artery Disease
Sponsor
University of Alberta
Enrollment
126
Locations
1
Primary Endpoint
Adherence to the study protocol
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
March 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sean van Diepen

Assistant Professor of Critical Care Medicine and Cardiology

University of Alberta

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing elective or urgent isolated CABG and/or valvular repari or replacement surgery
  • On an ACE or ARB for a minimum of 7 days

Exclusion Criteria

  • Emergency surgery
  • Pre-operative shock (defined as systolic blood pressure \< 90 mmHg, the need for any vasopressor or inotropic support, or a mechanical cardiac support device)
  • Severe uncontrolled pre-operative hypertension (defined as blood pressure ≥ 200 mmHg systolic or ≥120mmHg diastolic mmHG or the pre-operative need for intravenous anti-hypertensive agents)
  • ACE or ARB therapy \< 7 days
  • Any mineralocorticoid receptor antagonist therapy.

Arms & Interventions

ACE/ARB Continuation

ACE/ARB will be continued up to and including the morning of surgery.

Intervention: ACE/ARB continuation

ACE/ARB withdrawal

ACE/ARB will be discontinued medication 48 hours prior to surgery

Intervention: ACE/ARB withdrawal

Outcomes

Primary Outcomes

Adherence to the study protocol

Time Frame: From randomization to surgery

Proportion of patients who adhere to ACE/ARB continuation or withdrawal as randomized

Feasibility of study enrollment

Time Frame: 30 dasys

\>50% of eligible patients are successfully enrolled in the trial

Feasibility of Study

Time Frame: 60 days

\>=95% completeness of outcomes

Secondary Outcomes

  • Vasodilator use(7 days)
  • Incidence of post operative Shock(3 hours)
  • Duration of Shock(7 days)
  • Post operative intravenous anti-hypertensive use(7 days)
  • Feasibility of the Study(30 days)
  • Change in renal function(7 days)
  • Stroke(30 days)
  • Post-operative acute kidney injury(7 days)
  • Vasopressors use(7 days)
  • Duration of intravenous vasodilator use(7 days)
  • Incidence of vasoplegic shock(4 hours)
  • Pre-operative heart failure deterioration(48 hours)
  • Initiation of renal replacement therapy(7 days)
  • Peak post-operative troponin(72 hours)
  • In hospital Mortality(Participants will be followed for the duration of hospital stay, an expected average of 7 days)

Study Sites (1)

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