Ticagrelor Compared to Clopidogrel in Acute Coronary Syndromes

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The McGill University Health Center (MUHC) Division of Cardiology, with funding from the Canadian Institute of Health Research, is performing this randomized controlled trial to determine which dual antiplatelet therapy (DAPT), ticagrelor + aspirin (T+A) or clopidogrel and aspirin (C+A), is the most effective and safest for our patients. While the PLATO trial reported that T+A was superior, the prespecified group of North American patients (about 1/10 of the total study sample) actually did better with C+A, although this difference was not statistically significant. When the FDA approved T, they also stated: "Lack of Robustness of PLATO Superiority with Failure in the US Makes a Confirmatory Study Mandatory." As no confirmatory study has been done, this TC4 study aims to fill that void.

Study design: A cluster randomization design, so all patients will receive either T+A or C+A, depending on the month they arrive at the MUHC when they start their DAPT. We will follow patients through their electronic health records. The patients have no follow-up visits for this research project.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University Health Center; McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Aspirin; Clopidogrel; Platelet Aggregation Inhibitors; Ticagrelor

Criteria

Inclusion Criteria:

• Patients that are prescribed a dual-antiplatelet therapy (DAPT) regimen following an acute coronary syndrome (ACS) event.

• ACS, with or without ST-segment elevation.

• STEMI and NSTEMI positive biomarkers and appropriate ECG changes will be required.

• NSTEMI patients with negative biomarkers are generally considered as unstable angina and will also be eligible for study inclusion if their treating physician has determined that DAPT is appropriate.

• Patients provided written informed consent.

Exclusion Criteria:

• A decision from the patients attending physician to circumvent randomization and assign the patient a specific dual-antiplatelet therapy regimen.

• A contraindication to clopidogrel or ticagrelor

• Patients diagnosed with chronic total occlusion percutaneous coronary intervention (CTO PCI)