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Beta Blocker De-prescription After CABG Surgery for Heart Attack (BEEFBURGER Trial)

Phase 4
Recruiting
Research Sponsored by University of Saskatchewan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years treated with index isolated CABG
Be older than 18 years old
Must not have
Peri-CABG stroke
Prior heart failure with reduced ejection fraction (LVEF <45%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial found that in patients without reduced heart function or heart failure, beta-blockers did not have a significant impact on cardiovascular risk after CABG surgery.

Who is the study for?
The trial is for adults over 18 who've had coronary artery bypass graft surgery, are on beta blocker therapy at their 6-8 week check-up, and have a heart pumping function of at least 45%. It's not for those with past severe heart failure, recent abnormal heart rhythms or strokes around the time of their surgery.
What is being tested?
This study examines whether patients who've undergone bypass surgery but don't have high-risk features like severe heart failure can safely stop taking beta blockers—a common heart medication—without negative effects on their health.
What are the potential side effects?
While specific side effects aren't listed for stopping beta blockers in this context, generally reducing these medications can potentially lead to increased heart rate, blood pressure changes, and risk of chest pain or even a heart attack if done too quickly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 and have had a coronary artery bypass graft.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had a stroke after heart bypass surgery.
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I have had heart failure with a low heart pumping rate.
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I cannot commit to regular check-ups.
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I have had atrial fibrillation or flutter before or around the time of surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of all-cause mortality
Rate of cardiac arrhythmia
Rate of hospitalizations for heart failure
+4 more
Secondary study objectives
Change in patient reported quality of life (QoL) using Euro Qol (EQ) 5D questionnaire
Change in patient reported quality of life using Short Form (SF) 36 questionnaire
Change in the patient reported angina score using the Seattle Angina Questionnaire (SAQ)

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: De-prescribe beta blocker therapyExperimental Treatment1 Intervention
Beta blocker therapy will be de-prescribed in this arm
Group II: Continue beta blocker therapyActive Control1 Intervention
Participants in this arm will continue their beta blocker therapy as per their usual clinical care

Find a Location

Who is running the clinical trial?

University of SaskatchewanLead Sponsor
257 Previous Clinical Trials
155,891 Total Patients Enrolled
2 Trials studying Myocardial Infarction
260 Patients Enrolled for Myocardial Infarction
Canadian VIGOUR CentreOTHER
8 Previous Clinical Trials
10,798 Total Patients Enrolled
3 Trials studying Myocardial Infarction
912 Patients Enrolled for Myocardial Infarction
Haissam Haddad, MD, FRCPCStudy ChairUniversity of Saskatchewan
1 Previous Clinical Trials
36 Total Patients Enrolled

Media Library

De-prescribe beta blocker therapy Clinical Trial Eligibility Overview. Trial Name: NCT04788186 — Phase 4
Myocardial Infarction Research Study Groups: De-prescribe beta blocker therapy, Continue beta blocker therapy
Myocardial Infarction Clinical Trial 2023: De-prescribe beta blocker therapy Highlights & Side Effects. Trial Name: NCT04788186 — Phase 4
De-prescribe beta blocker therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04788186 — Phase 4
~47 spots leftby Dec 2025
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