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Status:

COMPLETED

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

Lead Sponsor:

Viatris Innovation GmbH

Conditions:

Acute Myocardial Infarction

Eligibility:

All Genders

18-85 years

Phase:

PHASE2

Brief 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 ne...

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 pathophysi...

Eligibility Criteria

Inclusion

  • Main
  • 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

  • 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

Key Trial Info

Start Date :

July 10 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 10 2018

Estimated Enrollment :

48 Patients enrolled

Trial Details

Trial ID

NCT03487445

Start Date

July 10 2018

End Date

November 10 2018

Last Update

July 9 2025

Active Locations (6)

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Page 1 of 2 (6 locations)

1

OLV Ziekenhuis Aalst

Aalst, Belgium, 9300

2

UZLeuven

Leuven, Belgium, 3000

3

Galilee Medical Center

Nahariya, Israel, 22100

4

Universitätsspital Basel

Basel, Switzerland, 4031