Outcomes of Angiotensin Converting Enzyme Inhibitor Management Strategies Prior to Coronary Artery Bypass
COMPACT
COMParison of Angiotensin Converting Enzyme Inhibitor managemenT Strategies Prior to Coronary Artery Bypass Surgery (the COMPACT Trial): a Pilot Randomized Controlled Registry Study
1 other identifier
interventional
126
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 coronary-artery-disease
Started Apr 2014
Longer than P75 for phase_2 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2014
CompletedFirst Posted
Study publicly available on registry
March 26, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedMarch 22, 2018
March 1, 2018
3.9 years
March 17, 2014
March 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Adherence to the study protocol
Proportion of patients who adhere to ACE/ARB continuation or withdrawal as randomized
From randomization to surgery
Feasibility of study enrollment
\>50% of eligible patients are successfully enrolled in the trial
30 dasys
Feasibility of Study
\>=95% completeness of outcomes
60 days
Secondary Outcomes (15)
Feasibility of the Study
30 days
Incidence of post operative Shock
3 hours
Duration of Shock
7 days
Vasopressors use
7 days
Post operative intravenous anti-hypertensive use
7 days
- +10 more secondary outcomes
Other Outcomes (4)
ACE or ARB use at hospital discharge
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Duration of post-operative mechanical ventilation
7 days
Cardiovascular ICU length of stay
Participants will be followed for the duration of the ICU stay, an expected average of 2 days
- +1 more other outcomes
Study Arms (2)
ACE/ARB Continuation
OTHERACE/ARB will be continued up to and including the morning of surgery.
ACE/ARB withdrawal
OTHERACE/ARB will be discontinued medication 48 hours prior to surgery
Interventions
ACE/ARB will be taken the morning of surgery with a sip of water
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Related Publications (1)
van Diepen S, Norris CM, Zheng Y, Nagendran J, Graham MM, Gaete Ortega D, Townsend DR, Ezekowitz JA, Bagshaw SM. Comparison of Angiotensin-Converting Enzyme Inhibitor and Angiotensin Receptor Blocker Management Strategies Before Cardiac Surgery: A Pilot Randomized Controlled Registry Trial. J Am Heart Assoc. 2018 Oct 16;7(20):e009917. doi: 10.1161/JAHA.118.009917.
PMID: 30371293DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sean van Diepen, MD, Msc
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Critical Care Medicine and Cardiology
Study Record Dates
First Submitted
March 17, 2014
First Posted
March 26, 2014
Study Start
April 1, 2014
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
March 22, 2018
Record last verified: 2018-03