A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Coronary Artery Disease
Condition: Stable Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Selatogrel; Placebo; Selatogrel
Intervention description: Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) or matching placebo will be reconstituted with 1 mL of water for injection. Further dilution with 1 mL sodium chloride (NaCl) 0.9% will be performed for preparation of the dose of 8 mg selatogrel.; Matching placebo for subcutaneous administration.; Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water for injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blinding will apply to treatment (ACT-246475 vs placebo). The dose (8 mg vs 16 mg) will be single blinded (subject blinded). The site for the sub-cutaneous injection (thigh vs abdomen) will not be blinded.
Enrollment: 346.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Chronic coronary syndrome

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. 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 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.