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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.
Full description
The purpose of this study is to assess the clinical efficacy of selatogrel when self-administered upon occurrence of symptoms suggestive of an acute myocardial infarction (AMI) in participants at risk of having a recurrent AMI.
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Inclusion and exclusion criteria
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:
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:
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.
Primary purpose
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14,000 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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