Aspirin-free ticagrelor treatment for heart attack patients managed without revascularization
Evaluation of an asPirin-free Strategy With ticAgrelor in patieNTs witH a Myocardial Infarction treatEd Medically alONe (PANTHEON)
PHASE3 · Montreal Heart Institute · NCT07257198
This trial will test whether taking ticagrelor alone (no aspirin) lowers bleeding without increasing heart problems in adults who had a heart attack and were treated medically without revascularization.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2570 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montreal Heart Institute (other) |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT07257198 on ClinicalTrials.gov |
What this trial studies
This is a phase 3, randomized, placebo-controlled trial comparing ticagrelor monotherapy to standard dual antiplatelet therapy (ticagrelor plus aspirin) for 12 months in patients discharged after a type 1 myocardial infarction managed without revascularization. The trial's co-primary goals are to test whether ticagrelor alone reduces BARC type 2, 3, or 5 bleeding at 12 months and to show non-inferiority for a patient-centered ischemic composite (death, MI, stroke, or coronary revascularization) at 12 months. Secondary endpoints include other bleeding classifications (BARC 3/5, TIMI) and individual ischemic outcomes such as cardiovascular death and any revascularization. Participants receive either ticagrelor plus placebo or ticagrelor plus aspirin and are followed with scheduled study visits through the 12-month period.
Who should consider this trial
Good fit: Adults (≥18) hospitalized for a type 1 MI who had a coronary angiogram and are planned for medical management only (no revascularization), able to attend study visits, and expected to live at least 12 months.
Not a fit: Patients who underwent or require revascularization, have type 2–5 MI or non-ischemic myocardial injury, need chronic oral anticoagulants, or have another clear indication for dual antiplatelet therapy are unlikely to benefit from this strategy.
Why it matters
Potential benefit: If successful, this approach could let some heart attack patients avoid aspirin and experience fewer bleeding complications while keeping similar protection against heart attacks and strokes.
How similar studies have performed: Similar aspirin-withdrawal strategies after PCI (for example TWILIGHT and TICO) have reduced bleeding with preserved ischemic protection, but applying ticagrelor monotherapy specifically to medically managed MI patients is less studied and more novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Age ≥18 years; * Hospitalized for type 1 MI, according to the 4th Universal Definition of MI; * Coronary angiogram performed; * Planned for medical management alone, without revascularization; * Willingness to participate and to attend study visits; * Expected life expectancy ≥12 months. Exclusion criteria: * Patients hospitalized for type 2-5 MI, or unstable angina, according to the 4th Universal Definition of MI; * Patients hospitalized for a STEMI with an acute thrombotic lesion of a major epicardial vessel; * Elevations in cardiac biomarkers (troponins or CK-MB) that is believed by the investigator not to be of ischemic origin (e.g. myocardial injury, myocarditis, Takotsubo syndrome, etc.); * Confirmed or suspected spontaneous coronary artery dissection; * Concomitant indication for chronic oral anticoagulant; * Concomitant non-coronary indication for dual antiplatelet therapy; * Use of any non-trial antiplatelet drug that needs to be continued based on the judgement of the treating physician; * Previous hospitalization for MI, PCI, or CABG within 12 months; * Known hypersensitivity, intolerance, or contra-indication to ASA or ticagrelor; * Unsuitability for either randomization treatment, based on the judgement of the treating physician
Where this trial is running
Montreal, Quebec
- Montreal Heart Institute — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Study coordinator: Guillaume Marquis-Gravel, MD
- Email: guillaume.marquis.gravel@umontreal.ca
- Phone: 1-514-376-3330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: NSTEMI - Non-ST Segment Elevation MI, STEMI, Myocardial Infarction, Dual antiplatelet therapy, NSTEMI, medical treatment, aspirin, ticagrelor