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A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Coronary Artery Disease
A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Coronary Artery Disease

NCT03384966

CompletedPhase 2

Sponsor: Viatris Innovation GmbH

Conditions: Stable Coronary Artery Disease

Interventions: Selatogrel, Placebo, Selatogrel

Countries: United States, Canada, Denmark, Germany, Netherlands, Singapore, Sweden, United Kingdom

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. Another goal is to know how fast and for how long selatogrel (ACT-246475) works and if there is a difference if the drug is injected in the thigh or in the belly. This study will also help to find out more about the safety of this new drug.

Eligibility overview

Sex: ALL

Age: 18 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Main Inclusion Criteria:

1. Signed informed consent prior to any study-mandated procedure.
2. Male and female subjects aged from 18-85 years, inclusive.
3. For women of childbearing potential: Negative urine pregnancy test at Visit 1 and at Visit 2 before randomization.
4. Stable Coronary artery disease (CAD) defined by the presence of any of the following conditions:

   1. History of CAD with coronary artery stenosis on coronary angiogram ≥50%.
   2. Previously documented myocardial infarction occurring more than 3 months prior to randomization.
5. Antiplatelet background therapy stable for at least 1 month prior to randomization.
6. Body weight ≥ 40.0 kg (88.2 lbs).

Main Exclusion Criteria:

1. Acute coronary syndrome, percutaneous coronary intervention or any intervention for peripheral artery disease within 3 months prior to randomization.
2. Acute ischemic stroke or transient ischemic attack (TIA) within 3 months prior to randomization.
3. 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).
4. Hemoglobin ≤ 10 g/dL at screening.
5. Loss of at least 250 mL of blood within 3 months of screening.
6. Use of anticoagulants (oral, parenteral) or fibrinolytic therapy within 24 h prior to screening (Visit 1).
7. Known platelet disorders (e.g., thrombasthenia, thrombocytopenia, von Willebrand disease).
8. Pregnant or breastfeeding women.
Locations (20)
  • Jacksonville, Florida, United States
  • Tampa, Florida, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • Lutherville, Maryland, United States
  • New York, New York, United States
  • Falls Church, Virginia, United States
  • Montreal, Quebec, Canada
  • Aarhus, Denmark
  • Copenhagen, Denmark
  • Bad Krozingen, Germany
  • Groningen, Netherlands
  • Maastricht, Netherlands
  • Nieuwegein, Netherlands
  • Singapore, Singapore
  • Gothenburg, Sweden
  • Uppsala, Sweden
  • Newcastle upon Tyne, United Kingdom
  • Sheffield, United Kingdom
  • Stevenage, United Kingdom