Phase 2
Completed N=48
A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Heart Attack
Source: ClinicalTrials.gov NCT03487445 ↗Enrolled (actual)
48
Serious AEs
4.3%
Results posted
Aug 2021
Primary outcomePrimary: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation — 21; 21 Count of participants — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation |
21; 21 | <0.001 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03487445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.