Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

Conditions

• Acute Myocardial Infarction

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Selatogrel — COMBINATION_PRODUCT
  Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. Selatogrel will be administered as a liquid formulation in a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system. Participants will self-administer 16 mg of selatogrel subcutaneously with the autoinjector upon occurrence of symptoms suggestive of an acute myocardial infarction. Self-administration encompasses the use of the autoinjector by another person (e.g., partner, close relative, friend, caregiver) who may be called for help during the emergency situation of a suspected AMI.
• Placebo — COMBINATION_PRODUCT
  Placebo will be administered as a liquid formulation in a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system. Participants will self-administer placebo subcutaneously with the autoinjector upon occurrence of symptoms suggestive of an acute myocardial infarction. Self-administration encompasses the use of the autoinjector by another person (e.g., partner, close relative, friend, caregiver) who may be called for help during the emergency situation of a suspected AMI.

Study Details

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.

Key Dates

Start date

Aug 14, 2021

Status verified

May 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

25,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Selatogrel
  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.
• Placebo Comparator: Placebo
  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.

Primary Outcome Measure

Clinical status as assessed by a 6-point ordinal scale [ Time Frame: Total duration: up to 7 days ]

Locations (81)

Find similar trials in Alexander City, AL

Related Studies

• Abbott Vascular Medical Device Registry
  Recruiting · Abbott Medical Devices · Birmingham, Alabama
• Arrhythmia Detection After MI
  Recruiting · Samir Saba · Pittsburgh, Pennsylvania
• Multi-center Collaborative to Enhance Quality and Outcomes in the Management of Cardiogenic Shock
  Recruiting · STAVROS G DRAKOS · Weston, Florida
• Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
  Recruiting · Population Health Research Institute · Los Angeles, California