Aspirin-free Strategy With Ticagrelor in Patients With a Myocardial Infarction Treated Medically Alone

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontreal Heart Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ticagrelor + placebo

    Drug

    Ticagrelor 90 mg twice daily + placebo once daily

  • Ticagrelor + aspirin

    Drug

    Ticagrelor 90 mg twice daily + aspirin 80 mg once daily

Treatment groups

2,570 Participants
are divided into 2 treatment groups
Group A: Ticagrelor monotherapyExperimental treatment 1 intervention
Group B: DAPT with ticagrelor and aspirinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Bleeding

Time to first BARC type 2, 3, or 5 bleeding

Time frame
From randomization to 12 months
2

Patient-oriented ischemic clinical endpoint

Time to first composite of all-cause mortality, MI, stroke, or any coronary revascularization

Time frame
From randomization to 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Montreal Heart Institute

Lead sponsor

Université de Montréal

Sponsor institution