Selatogrel for Heart Attack

(SOS-AMI Trial)

Recruiting at 523 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Idorsia Pharmaceuticals Ltd.

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

14000 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.

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).

How does the drug Selatogrel differ from other heart attack treatments?

Selatogrel is unique because it is a fast-acting antiplatelet drug that can be administered subcutaneously (under the skin), offering a potentially quicker and more convenient option compared to traditional oral antiplatelet medications used in heart attack management. ^{1 2 3 4 5}

Research Team

Clinical Trials

Principal Investigator

Idorsia Pharmaceuticals Ltd.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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?

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

References

1. England pubmed.ncbi.nlm.nih.gov

Suspected acute coronary syndrome in a theater of operations: first management, medical evacuation, and final diagnosis: experience of the French Medical Army. [2019]

2. Slovakia pubmed.ncbi.nlm.nih.gov

[Treatment of acute myocardial infarct]. [2016]

3. France pubmed.ncbi.nlm.nih.gov

[Mortality of myocardial infarction]. [2011]

4. England pubmed.ncbi.nlm.nih.gov

Acute myocardial infarction. Recommendations for medical management and primary angioplasty. [2017]

5. Germany pubmed.ncbi.nlm.nih.gov

[Modern treatment in acute coronary syndrome]. [2012]