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

March 20, 2018 updated by: Sean van Diepen, University of Alberta

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

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ACE/ARB Continuation
ACE/ARB will be continued up to and including the morning of surgery.
ACE/ARB will be taken the morning of surgery with a sip of water
Other: ACE/ARB withdrawal
ACE/ARB will be discontinued medication 48 hours prior to surgery
ACE/ARB will be stopped 48 hours prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to the study protocol
Time Frame: From randomization to surgery
Proportion of patients who adhere to ACE/ARB continuation or withdrawal as randomized
From randomization to surgery
Feasibility of study enrollment
Time Frame: 30 dasys
>50% of eligible patients are successfully enrolled in the trial
30 dasys
Feasibility of Study
Time Frame: 60 days
>=95% completeness of outcomes
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the Study
Time Frame: 30 days
Reasons for non-recruitment
30 days
Incidence of post operative Shock
Time Frame: 3 hours
Post-operative shock (use of any intravenous vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, and/or methylene blue) and mechanical support devices (left ventricular assist devices, intra-aortic balloon pumps, or extracorporeal membrane oxygenation) initiated within the first 3 hours of CVICU admission)
3 hours
Duration of Shock
Time Frame: 7 days
Post-operative shock (use of any intravenous vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, and/or methylene blue) and mechanical support devices (left ventricular assist devices, intra-aortic balloon pumps, or extracorporeal membrane oxygenation) initiated within the first 3 hours of CVICU admission)
7 days
Vasopressors use
Time Frame: 7 days
Number and maximum dose of vasopressors
7 days
Post operative intravenous anti-hypertensive use
Time Frame: 7 days
The post-operative use intravenous vasodilators (nitroglycerine or nitroprusside)
7 days
Duration of intravenous vasodilator use
Time Frame: 7 days
The post-operative duration intravenous vasodilators (nitroglycerine or nitroprusside)
7 days
Vasodilator use
Time Frame: 7 days
The number and maximum dose of vasodilators
7 days
Incidence of vasoplegic shock
Time Frame: 4 hours
Vasopressor administration for at lead 4 hours despite intravenous fluid administration
4 hours
Pre-operative heart failure deterioration
Time Frame: 48 hours
Any increase in diuretic dose in 48 hours prior to surgery
48 hours
Post-operative acute kidney injury
Time Frame: 7 days
Acute kidney injury defined as a doubling of serum creatinine within 7 days of surgery
7 days
Change in renal function
Time Frame: 7 days
Difference between baseline and peak post-operative creatinine
7 days
Initiation of renal replacement therapy
Time Frame: 7 days
7 days
Peak post-operative troponin
Time Frame: 72 hours
Peak post-operative troponin within 72 hours of surgery
72 hours
Stroke
Time Frame: 30 days
Incidence of any stroke within 30 days of surgery
30 days
In hospital Mortality
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Participants will be followed for the duration of hospital stay, an expected average of 7 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACE or ARB use at hospital discharge
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Duration of post-operative mechanical ventilation
Time Frame: 7 days
Time to extubation after admission to ICU
7 days
Cardiovascular ICU length of stay
Time Frame: Participants will be followed for the duration of the ICU stay, an expected average of 2 days
Participants will be followed for the duration of the ICU stay, an expected average of 2 days
ICU readmission
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Incidence and cause of any ICU readmission after discharge to lower acuity ward post-operatively.
Participants will be followed for the duration of hospital stay, an expected average of 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sean van Diepen, MD, MSc, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

March 17, 2014

First Submitted That Met QC Criteria

March 22, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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