Ticagrelor for Heart Attack

(PANTHEON Trial)

Overseen By Roseline Therrien

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Montreal Heart Institute

Must be taking: Antiplatelets

Must not be taking: Anticoagulants, Non-trial antiplatelets

Disqualifiers: Type 2-5 MI, STEMI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether ticagrelor alone can reduce bleeding events in people who have had a heart attack, compared to the usual treatment of ticagrelor plus aspirin. The researchers aim to determine if using only ticagrelor is equally safe and effective. Individuals hospitalized for a heart attack, without planned surgery, might qualify for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Is there any evidence suggesting that ticagrelor is likely to be safe for humans?

Research has shown that ticagrelor is generally safe for individuals who have experienced a heart attack. Studies found that ticagrelor can reduce the risk of serious heart problems, such as another heart attack, stroke, or death from heart-related causes. However, it may also increase the risk of major bleeding. While ticagrelor helps prevent heart issues, it can cause bleeding, which requires careful management.

Ticagrelor's safety is well-documented, as the FDA has already approved it for other heart conditions. This approval indicates that for many patients, the benefits of ticagrelor outweigh the risks, though individual experiences may vary. It is important to discuss potential risks and benefits with a healthcare provider before joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Ticagrelor is unique because it directly targets and inhibits the P2Y12 receptor on platelets, which plays a critical role in blood clot formation. Unlike traditional treatments for heart attacks, like aspirin, which primarily work by reducing the production of thromboxane, ticagrelor offers a more targeted approach to prevent clots. Researchers are excited about ticagrelor because it provides more consistent platelet inhibition and has a rapid onset and offset of action, which could lead to better outcomes for heart attack patients by minimizing bleeding risks while maximizing protection against further heart attacks.

What evidence suggests that ticagrelor might be an effective treatment for heart attack?

Research has shown that ticagrelor can lower the risk of heart attacks, strokes, and deaths related to heart problems. This medication prevents blood cells called platelets from sticking together, which helps stop clots from forming. However, studies have also found that ticagrelor can increase the risk of serious bleeding. In this trial, participants in the experimental arm will receive ticagrelor with a placebo, while those in the control arm will receive ticagrelor with aspirin. Previous studies comparing ticagrelor to clopidogrel did not show a significant difference in reducing major heart issues over a year. Overall, ticagrelor has been shown to help reduce heart-related events after a heart attack, but it comes with a higher risk of bleeding. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for patients who have had a myocardial infarction (heart attack) and are being treated without surgery. Participants should not be on other antiplatelet therapies, but specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

Coronary angiogram performed

Willingness to participate and to attend study visits

Expected life expectancy ≥12 months

Exclusion Criteria

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.)

Known hypersensitivity, intolerance, or contra-indication to ASA or ticagrelor

Unsuitability for either randomization treatment, based on the judgement of the treating physician

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ticagrelor monotherapy or dual antiplatelet therapy for 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ticagrelor

Trial Overview The PANTHEON trial is testing if taking ticagrelor alone can reduce bleeding compared to the standard treatment of ticagrelor with aspirin, without increasing the risk of heart-related issues over a period of 12 months.

How Is the Trial Designed?

Group I: Experimental arm Experimental Treatment 1 Intervention

Ticagrelor 90 mg orally twice daily + placebo orally once daily

Group II: Control arm Active Control 1 Intervention

Ticagrelor 90 mg orally twice daily + aspirin 80 mg orally once daily

Who Is Running the Clinical Trial?

Montreal Heart Institute

Lead Sponsor

Trials

125

Recruited

85,400+

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa1500857

Long-Term Use of Ticagrelor in Patients with Prior ... Treatment with ticagrelor significantly reduced the risk of cardiovascular death, myocardial infarction, or stroke and increased the risk of major bleeding.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8802857/

Effectiveness and Safety of Ticagrelor Implementation in ... Outcomes in patients treated with ticagrelor or clopidogrel after acute myocardial infarction: experiences from SWEDEHEART registry. Eur Heart J ...

3. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.031606

Review of the Ticagrelor Trials Evidence Base An exploratory efficacy analysis of 1‐year events similarly showed no benefit in cardiovascular death, MI, or stroke with ticagrelor compared ...

4. astrazeneca.com astrazeneca.com/content/astraz/media-centre/medical-releases/new-data-supports-long-term-efficacy-of-ticagrelor-in-patients-up-to-five-years-following-a-heart-attack-06092017.html

New data supports long-term efficacy of ticagrelor in ... It works by inhibiting platelet activation4 and has been shown to reduce the rate of atherothrombotic CV events, such as heart attack or ...

5. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2018/03/10/13/44/TREAT

Ticagrelor in Patients With ST-Elevation Myocardial ... The primary outcome of TIMI major bleeding occurred in 0.73% of the ticagrelor group vs. 0.69% of the clopidogrel group (p < 0.001 for ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0735109717390563

Efficacy and Safety of Ticagrelor Over Time in Patients With ... Ticagrelor reduces ischemic risk in patients with prior myocardial infarction (MI). It remains unclear whether ischemic risk and the benefits of prolonged ...