Navigating the clinical trial pathway: Conception, design, execution, and results dissemination.

Dr Sampalis is founder, Chief Executive Officer, and Chief Scientific Officer of JSS Medical Research Inc, founded in 1997. He is a tenured professor of Surgery and Epidemiology & Biostatistics of McGill University, the University of Montreal and University of Laval. Recognized as a leading clinical epidemiologist and one of the top trauma researchers in Canada, he possesses extensive expertise in health services research, clinical trials, and offers services as a Research and Epidemiological Consultant for numerous pharmaceutical companies, hospitals and government organizations and agencies.

A Randomized Trial Assessing the Effectiveness of Ezetimibe in South Asian Canadians with Coronary Artery Disease or Diabetes: The INFINITY Study.

Background. There is a paucity of data regarding the effectiveness and safety of lipid-lowering treatments among South-Asian patients. Methods.

Effectiveness and tolerability of ezetimibe co-administered with statins versus statin dose-doubling in high-risk patients with persistent hyperlipidemia: The EZE(STAT)2 trial.

Introduction: When a standard dose of statins fails to achieve lipid control in patients at high risk for coronary artery disease (CAD), increasing the statin dosage or co-administration of additional agents is recommended. The aim of this study was to compare the safety and lipid-lowering efficacy of doubling the standard statin dose (STAT2) to that of co-administering ezetimibe 10 mg/day (EZE+statin) in Canadian patients at high CAD risk with persistent hyperlipidemia upon statin treatment.

Material And Methods: Six-week, open-label, randomized, multicentre study.

Effectiveness of Ezetimibe in Reducing the Estimated Risk for Fatal Cardiovascular Events in Hypercholesterolaemic Patients with Inadequate Lipid Control While on Statin Monotherapy as Measured by the SCORE Model.

Objectives. The aim of this prospective cohort, multicentre study was to assess the effect of coadministrating ezetimibe 10 mg/day with an ongoing statin on the estimated risk for Cardiovascular (CVD) mortality in patients with persistently elevated LDL-C after statin monotherapy. Methods.

Reduction in estimated risk for coronary artery disease after use of ezetimibe with a statin.

Background: The aim of lipid-lowering treatment is to reduce the risk for cardiovascular events. Patients not at target lipid levels while on hydroxymethylglutaryl coenzyme A reductase inhibitors (statin) monotherapy are at increased cardiovascular risk.

Objective: To describe the impact of coadministration of ezetimibe with a statin on the estimated 10 year risk for coronary artery disease (E-R(CAD)) in patients with hypercholesterolemia and above-target low-density lipoprotein cholesterol (LDL-C) levels after statin monotherapy.

Efficacy and tolerability of ezetimibe 10 mg/day coadministered with statins in patients with primary hypercholesterolemia who do not achieve target LDL-C while on statin monotherapy: A Canadian, multicentre, prospective study--the Ezetrol Add-On Study.

Background: For patients who have above-target low-density lipoprotein cholesterol (LDL-C) levels while on statin monotherapy, coadministration of a cholesterol absorption inhibitor with the statin may decrease serum LDL-C levels and improve overall lipid profiles.

Objectives: To assess the effectiveness and safety of ezetimibe 10 mg/day coadministered with a statin in patients with primary hypercholesterolemia who have higher than recommended LDL-C levels while on statin monotherapy.

Methods: A six-week, prospective, multicentre study of eligible patients who had above-target LDL-C levels while on monotherapy with any statin, regardless of dose, for a minimum of four weeks.