NSTEMI - Non-ST Segment Elevation MIPhase 3PANTHEONNCT07257198
Aspirin-free Strategy With Ticagrelor in Patients With a Myocardial Infarction Treated Medically Alone
A Phase 3 study testing Ticagrelor + aspirin in people with NSTEMI - Non-ST Segment Elevation MI and STEMI (ST Elevation MI), run by Montreal Heart Institute at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSTEMI - Non-ST Segment Elevation MI, STEMI (ST Elevation MI), Myocardial Infarction
- What is being tested?
- Ticagrelor + aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,570 participants
- Where
- 1 siteCanada
- Study dates
- 3 Mar 2026to 1 Jan 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H1Y2P3
Guillaume Marquis-Gravel, MD, 1-514-376-3330 ext. 2777, guillaume.marquis.gravel@umontreal.ca
Samara Bloom, Msc, 1-514-376-3330 ext. 2698, samara.bloom@icm-mhi.org
About this study
Official title: 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.
Read the 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.
- Being tested
- Ticagrelor + placebo, Ticagrelor + aspirin
- Keywords
- Dual antiplatelet therapy, NSTEMI, medical treatment, STEMI, aspirin, ticagrelor, bleeding, ischemic events, randomized trial, pragmatic trial, randomized controlled trial
- Medical subject headings
- Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction, Myocardial Infarction, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor + placeboDrug
Ticagrelor 90 mg twice daily + placebo once daily
Ticagrelor + aspirinDrug
Ticagrelor 90 mg twice daily + aspirin 80 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor monotherapy | Experimental | Ticagrelor 90 mg orally twice daily + placebo orally once daily Receives: Drug: Ticagrelor + placebo |
| DAPT with ticagrelor and aspirin | Active comparator | Ticagrelor 90 mg orally twice daily + aspirin 80 mg orally once daily Receives: Drug: Ticagrelor + aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding
Time to first BARC type 2, 3, or 5 bleeding
Measured: From randomization to 12 months
Patient-oriented ischemic clinical endpoint
Time to first composite of all-cause mortality, MI, stroke, or any coronary revascularization
Measured: From randomization to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start3 Mar 2026
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSTEMI - Non-ST Segment Elevation MIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillaume Marquis-Gravel, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257198
- Sponsor's protocol ID
- MP-33-2026-3610
- Other IDs
- 202409PJT-525999-RC1-CFCK-1990
- Acronym
- PANTHEON
- Status last verified
- Mar 2026
- First submitted
- 20 Nov 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an asPirin-free Strategy With ticAgrelor in patieNTs witH a Myocardial Infarction treatEd Medically alONe (PANTHEON)
- ClinicalTrials.gov ID
- NCT07257198
- Acronym / sponsor ID
- PANTHEON / MP-33-2026-3610
- Keywords
- Dual antiplatelet therapy, NSTEMI, medical treatment, STEMI, aspirin, ticagrelor, bleeding, ischemic events
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,570 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor monotherapy | Experimental | Drug: Ticagrelor + placeboTicagrelor 90 mg orally twice daily + placebo orally once daily |
| DAPT with ticagrelor and aspirin | Active comparator | Drug: Ticagrelor + aspirinTicagrelor 90 mg orally twice daily + aspirin 80 mg orally once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ticagrelor + placeboTicagrelor 90 mg twice daily + placebo once daily | Drug | Ticagrelor monotherapy |
| Ticagrelor + aspirinTicagrelor 90 mg twice daily + aspirin 80 mg once daily | Drug | DAPT with ticagrelor and aspirin |
Primary outcome
Bleeding
Time frame: From randomization to 12 months
Time to first BARC type 2, 3, or 5 bleeding
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for NSTEMI - Non-ST Segment Elevation MI
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Active, not recruiting
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
Acute Myocardial Infarction, Coronary Artery Disease
Not yet recruitingObservational study
AI-ECG Detection of Occlusion Myocardial Infarction at Emergency Department Triage (TRIACS)
Acute Coronary Syndromes, Chest Pain
RecruitingObservational study
Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome
Acute Coronary Syndromes (ACS), Ventricular Tachycardia (VT)
Not yet recruitingObservational study
Germany on Target Registry
Myocardial Infarction (MI), Dyslipidemias
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ticagrelor + aspirin in people with NSTEMI - Non-ST Segment Elevation MI and STEMI (ST Elevation MI), run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Marquis-Gravel, MD (1-514-376-3330 ext. 2777, guillaume.marquis.gravel@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding (time frame: From randomization to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.