- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02096406
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
Conditions
Intervention / Treatment
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00042749
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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