No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
2,570 (estimated)
Sponsor
Montreal Heart Institute · Other
Who this trial is looking for
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In patients with a myocardial infarction (MI) treated medically alone, the objective of the PANTHEON trial is to evaluate if ticagrelor monotherapy reduces bleeding events, without an increase in patient-oriented ischemic events, compared with standard dual antiplatelet therapy (DAPT) with aspirin and ticagrelor for 12 months.
Trial Locations
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Status
Eligibility 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 …
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
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