Recruiting

Beta Blocker

Sponsor:

University of Saskatchewan

Code:

NCT04788186

Conditions

Coronary Artery Disease

Acute Myocardial Infarction

Coronary Artery Stenosis

ST Elevation Myocardial Infarction

Non-ST Elevation Myocardial Infarction (NSTEMI)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

De-prescribe beta blocker therapy

Study Details

Brief summary:

Beta-blockers have the greatest cardiovascular impact in patients with reduced heart function/heart failure and in reducing the peri-operative risk of atrial fibrillation. In patients without these high-risk features treated with coronary artery bypass graft (CABG) surgery, their continued long-term role is unclear.

Conditions

Coronary Artery Disease

Acute Myocardial Infarction

Coronary Artery Stenosis

ST Elevation Myocardial Infarction

Non-ST Elevation Myocardial Infarction (NSTEMI)

Study ID

NCT04788186

Start date

Aug 23, 2021

Status verified date

Nov, 2022

Completion date

Aug 31, 2025

Anticipated

Primary completion date

Aug 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18 years treated with index isolated CABG
  • Able to consent to study
  • On beta blocker therapy at the 6-8week visit
  • LV systolic function (≥45% assessed within 6months of CABG date)

Exclusion Criteria:

  • Prior heart failure with reduced ejection fraction (LVEF <45%)
  • Pre- or peri-operative atrial fibrillation or flutter
  • Peri-CABG stroke
  • Unable to follow-up

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Continue beta blocker therapy

Participants in this arm will continue their beta blocker therapy as per their usual clinical care

experimental: De-prescribe beta blocker therapy

Beta blocker therapy will be de-prescribed in this arm

Interventions

De-prescribe beta blocker therapy

Participants will be de-prescribed for beta-blocker therapy.

De-prescription will be performed as follows:

  • Half of pre-randomization dose for the first 3 days, then
  • Half of the above dose for the next 3 days, then discontinue

Primary outcome measure

  • Rate of all-cause mortality [ Time Frame: 3 years ]
  • Rate of spontaneous myocardial infarction [ Time Frame: 3 Years ]
  • Rate of stroke [ Time Frame: 3 Years ]
  • Rate of hospitalizations for heart failure [ Time Frame: 3 Years ]
  • Rate of cardiac arrhythmia [ Time Frame: 3 Years ]
  • Rate of syncope or need for permanent pacemaker [ Time Frame: 3 Years ]
  • Rate of recurrent myocardial ischemia [ Time Frame: 3 Years ]

Central Contacts and Locations

Central contacts

Jay Shavadia, MD

3069862260jss372@usask.ca

Natasha B Mostat, MSc

3063215708natasha.boyes@usask.ca

Locations

Royal University Hospital

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 0W8

Contacts

Jay Shavadia, MD

3069862260jss372@usask.ca

Principal Investigator:

Jay Shavadia, MD;MRCP(UK)

More Information

Sponsor

University of Saskatchewan

Last update posted

Nov 9, 2022

Last verified

Nov, 2022

Keywords

  • Beta Blocker drugs
  • coronary artery bypass graft
  • CABG
  • De-prescription

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2022-11-09.