Selatogrel for Heart Attack

(SOS-AMI Trial)

Enrolling by invitation at 727 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Viatris Innovation GmbH

Must not be taking: Triple antithrombotic therapy

Disqualifiers: Intracranial bleed, Liver impairment, Dialysis, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called selatogrel, an experimental drug, for individuals who recently experienced a heart attack (type 1 acute myocardial infarction) and have additional heart health risks. Researchers aim to determine if selatogrel can prevent future heart attacks or related issues. Participants will receive either the selatogrel treatment or a placebo (a non-active substance) for comparison. Those who had a heart attack in the last four weeks and have conditions like diabetes or chronic kidney issues might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in heart treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are already on oral triple antithrombotic therapy (a combination of blood-thinning medications).

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

Research has shown that selatogrel is generally safe for people. In studies, selatogrel effectively stopped platelets (tiny blood cells) from quickly sticking together in patients with heart problems. This action is crucial because it helps prevent blood clots, which can lead to heart attacks.

Early results suggest that a single dose of selatogrel did not cause serious side effects. Administered as an injection under the skin, it was well-tolerated by patients, indicating no major issues from the treatment. This makes selatogrel promising for those at risk of heart attacks, although ongoing studies will provide more detailed safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for heart attacks, such as aspirin or other antiplatelet drugs, Selatogrel acts quickly and is administered via injection, allowing for rapid absorption and action during acute episodes. Researchers are excited about Selatogrel because it targets the P2Y12 receptor on platelets, potentially reducing clot formation more effectively and quickly compared to oral medications. This fast-acting nature could be crucial in emergency situations, offering a new level of immediacy in treatment response that current oral options might not provide.

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

Research has shown that selatogrel quickly reaches its highest level in the blood within 30 minutes of administration. This rapid action is crucial for potentially stopping heart attacks faster. In this trial, some participants will receive selatogrel to test its effectiveness when self-administered at the onset of heart attack symptoms. The treatment aims to improve outcomes for individuals with coronary artery disease by being easy to use in emergencies. By swiftly preventing blood cells from clumping and forming clots, selatogrel may effectively help prevent heart attacks. ^{1 2 4 6 7}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Viatris Innovation GmbH

Are You a Good Fit for This Trial?

This trial is for patients who've had a type 1 heart attack within the last 4 weeks and have additional cardiovascular risks like diabetes, kidney disease, or prior heart attacks. They must be able to use an autoinjector and not have severe liver issues, recent strokes, known allergies to P2Y12 drugs like Selatogrel, bleeding risks or be on certain blood thinners.

Inclusion Criteria

I have severe blockage in multiple heart arteries and at least two major health issues like a previous heart attack, diabetes, kidney disease, or poor blood flow in my legs.

I had a heart attack within the last 4 weeks.

Successful self-administered placebo according to the autoinjector instruction for use training during screening.

Exclusion Criteria

I am currently on dialysis.

My liver function is significantly impaired.

I have had a stroke or a mini-stroke in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Treatment

Participants are randomized to receive either selatogrel or placebo, and self-administer the study treatment upon experiencing symptoms suggestive of an acute myocardial infarction

Up to 7 days

Visits triggered by self-administration of study treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of clinical status and bleeding events

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Selatogrel

Trial Overview The study tests Selatogrel against a placebo in people who recently had a heart attack. Participants are chosen at random after leaving the hospital to receive either the actual drug or a dummy injection without knowing which one they're getting.

How Is the Trial Designed?

Group I: Selatogrel Experimental Treatment 1 Intervention

Study treatment administration may occur at any time between the randomization visit and the final study visit when the participant experiences symptoms suggestive of an acute myocardial infarction. Study treatment administration triggers protocol pre-defined assessments or visits.

Group II: Placebo Placebo Group 1 Intervention

Study treatment administration may occur at any time between the randomization visit and the final study visit when the participant experiences symptoms suggestive of an acute myocardial infarction. Study treatment administration triggers protocol pre-defined assessments or visits.

Who Is Running the Clinical Trial?

Viatris Innovation GmbH

Lead Sponsor

Idorsia Pharmaceuticals Ltd.

Lead Sponsor

Trials

124

Recruited

36,400+

Antonio Olivieri

Idorsia Pharmaceuticals Ltd.

Chief Medical Officer since 2024

Not specified

André C. Muller

Idorsia Pharmaceuticals Ltd.

Chief Executive Officer

Not specified

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04957719

Selatogrel Outcome Study in Suspected Acute Myocardial ... The purpose of this study is to assess the clinical efficacy of selatogrel when self-administered upon occurrence of symptoms suggestive of an acute myocardial ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20537932

Selatogrel Outcome Study in Suspected Acute Myocardial ... The primary objective of the study is to assess the clinical effectiveness of selatogrel when self-administered upon occurrence of symptoms ...

3. jacc.org jacc.org/doi/10.1016/j.jacc.2020.03.054

Selatogrel for Acute Myocardial Infarction: The Promise ... Selatogrel was evaluated in stable coronary artery disease (12) and has demonstrated the ability to achieve peak plasma concentrations 30 min ...

4. ufhealthjax.org ufhealthjax.org/clinical-trials/selatogrel-outcome-study-in-suspected-acute-myocardial-infarction-sos-ami

Selatogrel Outcome Study in suspected Acute Myocardial ... Multi-center, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of self-administered subcutaneous…

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04957719/selatogrel-outcome-study-in-suspected-acute-myocardial-infarction

Selatogrel Outcome Study in Suspected Acute Myocardial ... This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32439008/

Subcutaneous Selatogrel Inhibits Platelet Aggregation in ... Single-dose subcutaneous administration of selatogrel in patients with AMI was safe and induced a profound, rapid, and dose-related antiplatelet response.

7. academic.oup.com academic.oup.com/eurheartj/article/41/33/3132/5625727

Pharmacodynamics, pharmacokinetics, and safety of single ... LTA data showed similarly rapid and potent inhibition of platelet aggregation. Selatogrel plasma concentrations peaked ∼30 min post-dose.