Study Type
Interventional - Procedure
completed
The primary objective of the COMPLETE study was to determine whether, on a background of optimal medical therapy with low dose ASA and ticagrelor, a strategy of multi-vessel revascularization, involving staged PCI using drug eluting stents of all suitable non-infarct related artery lesions, is superior to a strategy of culprit lesion only revascularization in reducing the composite outcome of CV death or new MI in patients with multi-vessel disease who have undergone successful culprit lesion primary PCI for STEMI.
Key secondary objectives:
- To determine whether complete revascularization reduces the composite of CV death, new MI or ischemia-driven revascularization, and;
- To determine whether the initial strategy of complete revascularization improves angina control, as assessed by the Seattle Angina Questionnaire (SAQ) Frequency Scale, and health-related quality of life, as assessed by the EQ-5D Quality of Life scale at six months and five year/final follow up compared to baseline.
COMPLETE Long-Term Follow Up
In an observational registry, up to 1500 consenting COMPLETE study participants (at a planned 55 sites in 3 countries) will be followed passively for five to 10 years. During this period, there will be no protocol-mandated therapies, and the primary care physicians will determine treatment of all study participants based on their interpretation of the available evidence.
The COMPLETE follow-up is focused on identifying the occurrence of deaths and major CV events and, if possible, linkages to administrative national or regional databases that record mortality and major morbidity (e.g. hospitalizations for myocardial infraction or stroke) will be conducted.
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COMPLETE Trial COMPLETE-Timing substudy COMPLETE-OCT substudy
Study Design
Randomized, prospective, multicenter, open label trial
NO. of Countries
31
NO. of Sites
140
NO. of Participants
4041
Study Period
2013-2019
Sponsor
PHRI
Shamir Mehta
Senior Scientist
Shamir Mehta
Senior Scientist
Shamir Mehta is a Principal Investigator for the Acute Coronary Syndrome and Interventional Cardiology programs at PHRI, Professor of Medicine at McMaster University, and Director of the Interventional Cardiology program at Hamilton Health Sciences. His research focuses on the role and timing of invasive therapies in patients with acute ischemic heart disease, and the evaluation of novel antiplatelet and anticoagulant therapies in these patients. He has led several large pragmatic randomized trials evaluating invasive interventional strategies in patients with acute coronary syndromes. He has also lead multinational randomized trials evaluating novel antiplatelet and anticoagulant therapies to improve outcomes in patients experiencing a heart attack.
Shamir Mehta has published 127 original research papers in several medical journals including The New England Journal of Medicine, The Lancet, JAMA, and Circulation. His success in research has earned him a coveted Canada’s Top 40 under 40TM award in 2004, and he has received a Canadian Institutes of Health Research New Investigator Career Award.
Tara McCready
Program Director
Tara McCready
Program Director
Tara McCready, PhD, oversees a variety of collaborative programs at PHRI, and serves as Project Manager for PHRI research studies and registries.
She was recruited to PHRI as a Program Director for the Canadian Network and Centre for Trials Internationally (CANNeCTIN), a national network funded by the CIHR/CFI Clinical Research Initiative program to improve the prevention and treatment of cardiac and vascular diseases and diabetes.
Previously the Executive Director of the Canadian Maternal, Infant, Child and Youth Research Network, Tara holds a PhD in Biochemistry and a MBA in Technology Commercialization from the University of Alberta.
Canadian Institutes of Health Research (CIHR)
Boston Scientific
AstraZeneca
ongoing
COMPLETE Long Term Follow Up
ACS and Interventional Cardiology
Consenting participants of the COMPLETE trial (Complete vs Culprit-only Revascularization Strategies to Treat Multi-vessel Disease...
