A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Heart Attack
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to find out how fast a drug called selatogrel (ACT-246475) can
      prevent platelets from binding together. This study will also help to find out more about the
      safety of this new drug. The drug selatogrel (ACT-246475) will be used in 2 different doses
      (8 mg or 16 mg) and will be administered in the thigh.
    

Detailed description: 
      This study is planned in patients presenting with Acute Myocardial Infarction (AMI) scheduled
      for an invasive strategy. Platelet activation and thrombus formation play a pivotal role in
      the pathophysiology of acute coronary syndrome. Early platelet inhibition has been shown to
      reduce the risk of recurrent events after a myocardial infarction.

      The screening period starts when the participant provides informed consent and ends with
      participant's randomization. Eligible participants had an acute myocardial infarction (AMI;
      ST-segment elevation myocardial infarction [STEMI] or non-ST-elevation myocardial infarction
      [NSTEMI]), a life-threatening condition, and will therefore fulfill the ICH-GCP definition of
      vulnerable subjects ("persons in emergency situations"). Accordingly, a specific process for
      obtaining consent in compliance with local regulations and approved by the independent ethics
      committee will be implemented.

      The study will be performed during a participant's hospital stay related to the qualifying
      AMI.

      Standard treatment of AMI is allowed including anticoagulants. Ticagrelor will be the only
      oral P2Y12 receptor antagonist allowed to be initiated during the study and its
      administration will be possible only after selatogrel administration. Use of fibrinolytics or
      GPIIb/IIIa inhibitors will be prohibited unless required for bail-out. All other
      standard-of-care treatments for AMI will be allowed without restriction.

      The treatment period starts with the participant's randomization and ends after the
      end-of-study assessments, approximately 48 hours after the administration of a single study
      treatment dose.
    

Intervention name(s): Selatogrel 8 mg; Selatogrel 16 mg
Intervention type(s): Drug; Drug
Intervention description(s): Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water and further diluted with 1 mL sodium chloride (NaCl) 0.9%.; Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water for injection.
Other intervention name(s): ACT-246475; ACT-246475
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment