stable coronary artery disease MedDRA version: 20.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Sponsors
Idorsia Pharmaceuticals Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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 CAD defined by the presence of any of the following conditions: a. History of CAD with coronary artery stenosis on coronary angiogram = 50%. b. 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). 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 124 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: starting 15 minutes after injection, for 24 h; Secondary end point(s): The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles. PK endpoints include: • Cmax. • tmax. • The AUC from time zero to 24 h time point (AUC0–24h). | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to characterize inhibition of platelet aggregation (IPA) relative to placebo after a single s.c. injection of ACT-246475 either in the thigh or in the abdomen at 2 different doses in subjects with stable coronary artery disease (CAD) receiving conventional background oral antiplatelet therapy (e.g., acetylsalicylic acid, P2Y12 receptor antagonists).; Secondary Objective: • To assess the pharmacokinetics (PK) of ACT-246475. • To assess the impact of the injection site location (thigh vs abdomen) on the PK and pharmacodynamics (PD) of ACT-246475. • To investigate the impact of concomitant drug use, age, sex, and other covariates on the PK and PD of ACT-246475. • To investigate the safety and tolerability of ACT-246475. ;Primary end point(s): The primary PD endpoint is the PD response that is defined for each subject as a P2Y12 Reaction Units 80%.;Timepoint(s) of evaluation of this end point: starting 15 minutes after injection, for 24 h | — |
Countries
Canada, Denmark, France, Germany, Netherlands, Singapore, Sweden, United Kingdom, United States
Contacts
Public ContactClinical Trial Disclosure Desk
Idorsia Pharmaceuticals Ltd.
Outcome results
None listed