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P2Y12 receptor inhibitor
Ticagrelor Compared to Clopidogrel in Acute Coronary Syndromes (TC4 Trial)
Phase 4
Waitlist Available
Led By James Brophy, MD, PhD
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing two combinations of blood-thinning medications to find out which is safer and more effective for patients with heart problems. The medications help prevent blood cells from forming clots, reducing the risk of heart attacks.
Eligible Conditions
- Acute Coronary Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The hazard ratio for the number of participants that develop the outcome, a composite of cardiovascular-related mortality, myocardial infarction (MI), or stroke.
Side effects data
From 2021 Phase 3 trial • 76 Patients • NCT0364971148%
Bruise
20%
Dyspnea
8%
Fatigue
4%
Hospitalization
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental: CKD-Ticagrelor
Arm: Active Comparator: CKD-Clopidogrel
Arm: Active Comparator: Control-ticagrelor
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Ticagrelor 90mgExperimental Treatment2 Interventions
Ticagrelor: 180 mg loading dose followed by 90 mg BID. Aspirin: 325 loading dose followed by 81 mg daily.
Group II: Clopidogrel 75mgActive Control2 Interventions
Clopidogrel: 300 mg loading dose followed by 75 mg daily. Aspirin: 325 loading dose followed by 81 mg daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ticagrelor
FDA approved
Acetylsalicylic acid
FDA approved
Find a Location
Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
470 Previous Clinical Trials
165,906 Total Patients Enrolled
1 Trials studying Acute Coronary Syndrome
65 Patients Enrolled for Acute Coronary Syndrome
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,391 Previous Clinical Trials
26,528,104 Total Patients Enrolled
9 Trials studying Acute Coronary Syndrome
8,921 Patients Enrolled for Acute Coronary Syndrome
James Brophy, MD, PhDPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre