NCT07257198

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

Evaluation of an asPirin-free Strategy With ticAgrelor in patieNTs witH a Myocardial Infarction treatEd Medically alONe (PANTHEON)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,570 (estimated)
• Sponsor: Montreal Heart Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Coronary artery disease is associated with more than 9 million deaths per year worldwide. Following hospital discharge for an MI, both bleeding and recurrent ischemic events are associated with a high risk of subsequent mortality. However, the optimal antiplatelet strategy balancing bleeding and ischemic risks in the vulnerable population of patients with a medically managed MI patients (without revascularization) remains unknown, leading to substantial variability in clinical practice. This group represents 35-45% of patients wit hMI in Canada and the United States. Primary Objectives To evaluate whether ticagrelor monotherapy is superior to dual antiplatelet therapy (DAPT) in reducing the risk of type 2, 3, or 5 bleeding events according to the BARC classification at 12 months. To evaluate whether ticagrelor monotherapy is non-inferior to dual antiplatelet therapy (DAPT) for the composite endpoint of all-cause mortality, myocardial infarction, stroke, or coronary revascularization - a standardized, patient-centered ischemic clinical endpoint as defined by the Academic Research Consortium - at 12 months. Secondary Objectives To evaluate differences between ticagrelor monotherapy and DAPT regarding the following endpoints at 12 months: individual components of the two primary endpoints; BARC type 3 or 5 bleeding; TIMI minor or major bleeding and its individual components; cardiovascular mortality; any coronary revascularization; the composite of all-cause mortality, MI, or stroke; and NACE, a composite of all-cause mortality, MI, stroke, any coronary revascularization, or type 2, 3, or 5 BARC bleeding.

Conditions

• NSTEMI - Non-ST Segment Elevation MI
• STEMI (ST Elevation MI)
• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Ticagrelor + placebo	Ticagrelor 90 mg twice daily + placebo once daily
DRUG	Ticagrelor + aspirin	Ticagrelor 90 mg twice daily + aspirin 80 mg once daily

Timeline

• Start date: 2026-03-03
• Primary completion: 2030-01-01
• Completion: 2031-01-01
• First posted: 2025-12-02
• Last updated: 2026-03-10

Locations

1 site across 1 country: Canada