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

March 8, 2026 updated by: Guillaume Marquis-Gravel, Montreal Heart Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

2570

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ticagrelor monotherapy
Ticagrelor 90 mg orally twice daily + placebo orally once daily
Drug: Ticagrelor + placebo
Ticagrelor 90 mg twice daily + placebo once daily
Active Comparator: DAPT with ticagrelor and aspirin
Ticagrelor 90 mg orally twice daily + aspirin 80 mg orally once daily
Drug: Ticagrelor + aspirin
Ticagrelor 90 mg twice daily + aspirin 80 mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding
Time Frame: From randomization to 12 months
Time to first BARC type 2, 3, or 5 bleeding
From randomization to 12 months
Patient-oriented ischemic clinical endpoint
Time Frame: From randomization to 12 months
Time to first composite of all-cause mortality, MI, stroke, or any coronary revascularization
From randomization to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal Heart Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2031

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 8, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-33-2026-3610
  • 202409PJT-525999-RC1-CFCK-1990 (Other Grant/Funding Number: Canadian Institutes of Health Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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