A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Heart Attack

• Status: Completed
• Trial end date: 2018-11-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Criteria

Main Inclusion Criteria:

• Informed consent obtained prior to any study-mandated procedure,

• Males aged from 18 to 85 and postmenopausal females aged up to 85 years,

• Onset of symptoms of AMI of more than 30 min and less than 6 hours prior to randomization,

• Subjects presenting a type I AMI including STEMI or NSTEMI.

Main Exclusion Criteria:

• Cardiogenic shock or severe hemodynamic instability,

• Cardiopulmonary resuscitation,

• Loading dose of any oral P2Y12 receptor antagonist prior to randomization,

• Planned fibrinolytic therapy or any fibrinolytic therapy administered within 24 h prior to randomization,

• Known platelet disorders (e.g., thromboasthenia, thrombocytopenia, von Willebrand disease).

• Active internal bleeding, or bleeding diathesis or conditions associated with high risk of bleeding.

• Known clinically important anemia.

• Oral anticoagulation therapy within 7 days prior to randomization