Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

Condition(s) studied

Investigational drug(s) / intervention(s)

Selatogrel: 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: 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 summary

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.

Eligibility

Primary outcome measure(s)

• Clinical status as assessed by a 6-point ordinal scale — Total duration: up to 7 days
  The clinical status will be assessed using a 6-point ordinal scale after any study treatment self-administration. Only the worst clinical outcome will be retained as the primary efficacy outcome. The 6 mutually exclusive outcomes ranked from worst to best are: 1. Death (all causes), within 7 days after study treatment administration. 2. Acute myocardial infarction with compromised electro-hemodynamics, within 2 days after study treatment administration. 3. ST-Elevation Myocardial Infarction (STEMI), within 2 days after study treatment administration. 4. High-risk Non-ST-Elevation Myocardial Infarction (NSTEMI), within 2 days after study treatment administration. 5. NSTEMI with peak cardiac troponin greater than 10 times upper limit of normal, within 2 days after study drug administration. 6. None of the above
• Occurrence of Type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition — Total duration: up to 2 days
  The number of: * Type 3 treatment-emergent bleeding events and * Type 5 treatment-emergent bleeding events will be assessed according to the Bleeding Academic Research Consortium (BARC) definition (Mehran et al. 2011), within 2 days after study treatment administration. The Bleeding Academic Research Consortium (BARC) definitions are: * Type 3, bleeding is divided into 3 categories, a through c, and includes clinical, laboratory, and/or imaging evidence of bleeding with specific healthcare provider responses. * Type 5, bleeding is fatal.

Trial sites (821)

+ 781 more sites — see the full list on the official registry below.