Grant: Operating Grant: SPOR Innovative Clinical Trial Multi-Year Grant - LOI

Stable ischemic heart disease (SIHD) affects an estimated 2.4 million Canadians and 16,000 new patients are diagnosed annually. Improvements in medical therapies for secondary prevention have contributed to a decline in mortality from both heart attack, and SIHD. A consequence of decades of 'add-on' drug development is polypharmacy in people with SIHD; where older therapies, such as Beta-blockers, with uncertain clinical efficacy continue to be prescribed with newer contemporary vascular protective treatments (e.g., angiotensin converting enzyme inhibitors, statins) continue to be prescribed. The increased pill burden may lead to drug interactions, side-effects (e.g. hypotension, depression, new-onset diabetes), and higher healthcare costs. Thus, there is a pressing need to evaluate the potential benefits and safety of stopping Beta-blockers in asymptomatic patients with SIHD in the current treatment era. We propose expanding an ongoing pragmatic randomized trial to addresses this significant knowledge gap in current evidence-based practice. The study will randomly allocate participants to Beta-blockers continuation or discontinuation and the primary endpoint will be the first incidence of all-cause death, or non-fatal myocardial infarction, or hospitalization for resuscitated cardiac arrest, or unstable angina requiring urgent revascularization, or heart failure over four years. The study will align with Canadian Institutes of Health Research's Innovative Clinical Trial criteria by: (1) focusing on patient-oriented outcomes that have been developed in collaboration with a patient advisory committee, (2) leverage population health data sets to pragmatically identify and enrol patients, including populations traditionally underrepresented in clinical trials using 'permission-to-contact' lists; (3) utilizing population-based data sets for pragmatic clinical event ascertainment.