Eligible participants must be 18 or over and recently discharged from the hospital with a confirmed diagnosis of symptomatic type 1 acute myocardial infarction (AMI) with additional cardiovascular risk factors (e.g. second prior acute myocardial infarction, diabetes mellitus, chronic kidney disease, multivessel coronary artery disease, peripheral artery disease, 65 or over, active daily smoking). Individuals with a high risk of serious bleeding are not qualified for the study.
Participants will receive active investigational medication or placebo, via self-injection. Participants will not have to pay for the study medication or for tests done specifically for this study which are not covered by their health insurance. Reimbursement for study-related expenses may be provided.
The study is divided into 2 consecutive periods including screening and the observation period. The anticipated duration of study participation is about 6 months to 30 months with continuous telephone visits and about 3-4 on-site visits.
Peterborough - Kawartha Cardiology Clinical Trials
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Last Update Posted: September 24, 2023
NCT04957719
Idorsia Pharmaceuticals Ltd.
Brief Summary:
This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.
Condition or Disease:
Acute Myocardial Infarction
Intervention/Treatment:
Combination Product: SelatogrelPhase:
Phase 3
Ages Eligible for Study:
18 Years and older (Adult)
Sexes Eligible for Study:
All
Main Inclusion Criteria:
Confirmed diagnosis of symptomatic type 1 acute myocardial infarction (AMI) ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial Infarction (NSTEMI), no longer than 4 weeks prior to randomization.
Diagnosis of multivessel coronary artery disease defined as ≥ 50% stenosis on 2 or more coronary artery territories or on the left main artery during a prior cardiac catheterization or cardiac catheterization during the qualifying AMI event and presence of at least 2 of the following risk factors:
Second prior AMI,
Diabetes mellitus defined by ongoing glucose lowering treatment,
Chronic kidney disease with estimated glomerular filtration rate less-than 60 mL/min/1.73 m2,
Peripheral artery disease at any time prior to randomization,
Absence of, or unsuccessful coronary revascularization of the qualifying AMI.
Successful self-administered placebo according to the autoinjector instruction for use training during screening.
Main Exclusion Criteria:
Increased risk of serious bleeding including any of the following:
History of intracranial bleed at any time.
Known uncorrected intracranial vascular abnormality.
Gastrointestinal bleed requiring hospitalization or transfusion within 1 year prior to screening.
Already on oral triple antithrombotic therapy (i.e., Dual antiplatelet therapy and oral anticoagulant).
Known liver impairment significantly affecting the hepatic function.
Current dialysis.
Ischemic stroke or transient ischemic attack within 3 months of screening.
Chronic anemia with hemoglobin < 10 g/dL.
Chronic thrombocytopenia with platelet count < 100,000/mm3.
Known hypersensitivity to selatogrel, any of its excipients, or drugs of the P2Y12 class.
Previous exposure to an investigational drug within 3 months prior to randomization.
Participation in another clinical trial with an investigational product or device within 3 months prior to randomization.
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