Coronary Artery DiseasePhase 2COMPACTNCT02096406
Outcomes of Angiotensin Converting Enzyme Inhibitor Management Strategies Prior to Coronary Artery Bypass
A Phase 2 study testing ACE/ARB continuation and ACE/ARB withdrawal in people with Coronary Artery Disease, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- ACE/ARB continuation and ACE/ARB withdrawal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Mar 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Being tested
- ACE/ARB continuation, ACE/ARB withdrawal
- Keywords
- Coronary artery disease, Coronary artery bypass grafting, angiotensin converting enzyme inhibitor, angiotensin receptor blocker, Surgical valve repair, Valve Replacement
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE/ARB continuationDrug
ACE/ARB will be taken the morning of surgery with a sip of water
ACE/ARB withdrawalDrug
ACE/ARB will be stopped 48 hours prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| ACE/ARB Continuation | Other | ACE/ARB will be continued up to and including the morning of surgery. Receives: Drug: ACE/ARB continuation |
| ACE/ARB withdrawal | Other | ACE/ARB will be discontinued medication 48 hours prior to surgery Receives: Drug: ACE/ARB withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the study protocol
Proportion of patients who adhere to ACE/ARB continuation or withdrawal as randomized
Measured: From randomization to surgery
Feasibility of study enrollment
>50% of eligible patients are successfully enrolled in the trial
Measured: 30 dasys
Feasibility of Study
>=95% completeness of outcomes
Measured: 60 days
Secondary outcomes (15)
Feasibility of the Study
Reasons for non-recruitment
Measured: 30 days
Incidence of post operative Shock
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)
Measured: 3 hours
Duration of Shock
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)
Measured: 7 days
Vasopressors use
Number and maximum dose of vasopressors
Measured: 7 days
Post operative intravenous anti-hypertensive use
The post-operative use intravenous vasodilators (nitroglycerine or nitroprusside)
Measured: 7 days
Duration of intravenous vasodilator use
The post-operative duration intravenous vasodilators (nitroglycerine or nitroprusside)
Measured: 7 days
Vasodilator use
The number and maximum dose of vasodilators
Measured: 7 days
Incidence of vasoplegic shock
Vasopressor administration for at lead 4 hours despite intravenous fluid administration
Measured: 4 hours
Pre-operative heart failure deterioration
Any increase in diuretic dose in 48 hours prior to surgery
Measured: 48 hours
Post-operative acute kidney injury
Acute kidney injury defined as a doubling of serum creatinine within 7 days of surgery
Measured: 7 days
Change in renal function
Difference between baseline and peak post-operative creatinine
Measured: 7 days
Initiation of renal replacement therapy
Measured: 7 days
Peak post-operative troponin
Peak post-operative troponin within 72 hours of surgery
Measured: 72 hours
Stroke
Incidence of any stroke within 30 days of surgery
Measured: 30 days
In hospital Mortality
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean van Diepen, University of Alberta
- Investigators
- Sean van Diepen, MD, Msc, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096406
- Sponsor's protocol ID
- Pro00042749
- Acronym
- COMPACT
- Status last verified
- Mar 2018
- First submitted
- 17 Mar 2014
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30371293
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMParison of Angiotensin Converting Enzyme Inhibitor managemenT Strategies Prior to Coronary Artery Bypass Surgery (the COMPACT Trial): a Pilot Randomized Controlled Registry Study
- ClinicalTrials.gov ID
- NCT02096406
- Acronym / sponsor ID
- COMPACT / Pro00042749
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Coronary artery bypass grafting, angiotensin converting enzyme inhibitor, angiotensin receptor blocker, Surgical valve repair, Valve Replacement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACE/ARB Continuation | Other | Drug: ACE/ARB continuationACE/ARB will be continued up to and including the morning of surgery. |
| ACE/ARB withdrawal | Other | Drug: ACE/ARB withdrawalACE/ARB will be discontinued medication 48 hours prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACE/ARB continuationACE/ARB will be taken the morning of surgery with a sip of water | Drug | ACE/ARB Continuation |
| ACE/ARB withdrawalACE/ARB will be stopped 48 hours prior to surgery | Drug | ACE/ARB withdrawal |
Primary outcome
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
15 secondary outcomes
Feasibility of the Study
Time frame: 30 days
Incidence of post operative Shock
Time frame: 3 hours
Duration of Shock
Time frame: 7 days
Vasopressors use
Time frame: 7 days
Post operative intravenous anti-hypertensive use
Time frame: 7 days
Duration of intravenous vasodilator use
Time frame: 7 days
Vasodilator use
Time frame: 7 days
Incidence of vasoplegic shock
Time frame: 4 hours
Pre-operative heart failure deterioration
Time frame: 48 hours
Post-operative acute kidney injury
Time frame: 7 days
Change in renal function
Time frame: 7 days
Initiation of renal replacement therapy
Time frame: 7 days
Peak post-operative troponin
Time frame: 72 hours
Stroke
Time frame: 30 days
In hospital Mortality
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Derived from this study: PubMed 30371293van 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean van Diepen, MD, Msc principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACE/ARB continuation and ACE/ARB withdrawal in people with Coronary Artery Disease, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the study protocol (time frame: From randomization to surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02096406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.