Antidepressant prevention of depression and cardiovascular sequelae post-acute coronary syndrome: The “AVERT” trial

ObjectiveMajor depression is an independent risk factor for increased mortality and morbidity following acute coronary syndromes (ACS). Depression after stroke is similarly associated with high incidence of morbidity and mortality. Recent studies demonstrated efficacy at preventing post-stroke depression by prophylactic use of sertraline. Will a selective serotonin reuptake inhibitors (SSRI) antidepressant similarly prevent depression after ACS? Will it result in a significant reduction of morbidity and mortality? We present the design of a pilot conducted as a single site, double-blind, randomized, placebo-controlled trial. Sertraline is introduced to non-depressed patients, stabilized following an acute myocardial infarction or unstable angina. The primary aim is to determine feasibility of the study by assessing the recruitment rate, attrition rates and follow-up completion. A secondary aim is to assess tolerability and safety of sertraline following an ACS or unstable angina.Method40 inpatients with recent ACS and negative for depression on the Brief Patient Health Questionnaire (BPH-Q) and the 24-item Hamilton Depression Rating Scale (HAM-D) will be randomly assigned to sertraline or pill-placebo groups. Feasibility assessment will be based upon successful recruitment, ≤ 10% drop-out, ≥ 90% adherence to study drug and an absence of significant adverse events.ResultsNot applicable.ConclusionsIf deemed feasible, this pilot study will serve to enlist sufficient resources to establish and conduct a large multicentre trial.