Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Myocardial Infarction
  • Coronary (Artery) Disease
  • Coronary Artery Stenosis
  • Non ST Elevation Myocardial Infarction (NSTEMI)
  • ST Elevation Myocardial Infarction
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: open-label, non-inferiority, randomized comparisonMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This is an open-label, non-inferiority, randomized comparison of beta-blocker continuation versus de-prescription at the 6-8 week follow-up following isolated and uncomplicated CABG at Royal University Hospital, Saskatoon. Patients treated with isolated CABG (without valve repair/replacement) and di...

This is an open-label, non-inferiority, randomized comparison of beta-blocker continuation versus de-prescription at the 6-8 week follow-up following isolated and uncomplicated CABG at Royal University Hospital, Saskatoon. Patients treated with isolated CABG (without valve repair/replacement) and discharged on a beta-blocker are eligible for recruitment if they have preserved systolic function (EF ?50%) and no history of heart failure, atrial fibrillation/flutter, or an alternate compelling indication for beta-blocker therapy. After obtaining informed consent, eligible patients are randomly assigned at 6-8 weeks to one of the two treatment groups: continued beta-blocker therapy per their usual clinical care OR beta-blocker de-prescription as per the study protocol. The primary safety outcome of this study is a composite of all-cause mortality, myocardial infarction, stroke, arrhythmia, cardiovascular-related hospitalization (congestive heart failure, recurrent ischemia, arrhythmia [supraventricular including atrial fibrillation, and ventricular], syncope or need for pacemaker), or re-initiation for systemic hypertension over a 5-year follow up duration. Key secondary safety outcomes will include the individual components of the primary composite, and a change in patient-reported quality of life.

Tracking Information

NCT #
NCT04788186
Collaborators
Canadian VIGOUR Centre
Investigators
Study Chair: Haissam Haddad, MD, FRCPC University of Saskatchewan