A medical research study to evaluate the effects of ACT-245475 in adults with heart attack

Phase 1

• Conditions: Acute myocardial infarction; MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-000765-36-BE
• Lead Sponsor: Idorsia Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-03
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 42

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to assess the inhibition of platelet aggregation (IPA) 30 minutes after a single subcutaneous (s.c.) injection of ACT-246475 in subjects with acute myocardial infarction (AMI) receiving conventional antithrombotic treatment (e.g., aspirin, oral P2Y12 receptor antagonists, anticoagulants);Secondary Objective: NA;Primary end point(s): The primary PD endpoint is the response to the treatment defined for each subject as a P2Y12 reaction units value < 100 at the 30 min post-dose time point, as measured via VerifyNow®. This corresponds to an inhibition of ADP-induced platelet aggregation > 80%.;Timepoint(s) of evaluation of this end point: 30 minutes post-dose

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA