Status:
COMPLETED
A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Coronary Artery Disease
Lead Sponsor:
Viatris Innovation GmbH
Conditions:
Stable Coronary Artery Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
The goal of this study is to find out if a drug called selatogrel (ACT-246475) can prevent platelets from binding together when administered by an injection under the skin in the thigh or in the belly...
Detailed Description
To investigate the pharmacodynamic (PD) and pharmacokinetic (PK) properties of selatogrel in patients with atherosclerotic disease, the present study will be conducted in patients with chronic coronar...
Eligibility Criteria
Inclusion
- Main
- Signed informed consent prior to any study-mandated procedure.
- Male and female subjects aged from 18-85 years, inclusive.
- For women of childbearing potential: Negative urine pregnancy test at Visit 1 and at Visit 2 before randomization.
- Stable Coronary artery disease (CAD) defined by the presence of any of the following conditions:
- History of CAD with coronary artery stenosis on coronary angiogram ≥50%.
- Previously documented myocardial infarction occurring more than 3 months prior to randomization.
- Antiplatelet background therapy stable for at least 1 month prior to randomization.
- Body weight ≥ 40.0 kg (88.2 lbs).
- Main
Exclusion
- Acute coronary syndrome, percutaneous coronary intervention or any intervention for peripheral artery disease within 3 months prior to randomization.
- Acute ischemic stroke or transient ischemic attack (TIA) within 3 months prior to randomization.
- Active internal bleeding, or medical history of recent (\< 1 month) bleeding disorders or conditions associated with high risk of bleeding (e.g., clotting disturbances, gastrointestinal bleed, hemoptysis).
- Hemoglobin ≤ 10 g/dL at screening.
- Loss of at least 250 mL of blood within 3 months of screening.
- Use of anticoagulants (oral, parenteral) or fibrinolytic therapy within 24 h prior to screening (Visit 1).
- Known platelet disorders (e.g., thrombasthenia, thrombocytopenia, von Willebrand disease).
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
January 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2018
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT03384966
Start Date
January 24 2018
End Date
September 18 2018
Last Update
July 9 2025
Active Locations (20)
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1
University of Florida (UF) Jacksonville
Jacksonville, Florida, United States, 32209
2
Florida Hospital Tampa - Pepin Heart Institute
Tampa, Florida, United States, 33613
3
NorthShore University
Chicago, Illinois, United States, 73104
4
Indiana University School of Medicine - Krannert Institute of Cardiology
Indianapolis, Indiana, United States, 46202