Acute Myocardial Infarction
Conditions
Interventions
Participants will self-administer 16 mg of selatogrel or placebo subcutaneously with the autoinjector upon occurrence of symptoms suggestive of an acute myocardial infarction. Self-administration enco
Sponsors
Nakano Satoko
Eligibility
Sex/Gender
All
Inclusion criteria
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, including the left main artery, during a prior cardiac catheterization or cardiac catheterization during the qualifying AMI event and presence of at least 1 of the following risk factors: -Second prior AMI, -Diabetes mellitus defined by ongoing glucose lowering treatment, -Chronic kidney disease defined as estimated glomerular filtration rate less than 60 mL/min/1.73 m2 and either known history of chronic kidney disease or a biomarker of chronic kidney damage, -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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical status as assessed by a 6-point ordinal scale: The clinical status will be assessed using a 6-point ordinal scale after any study treatment self-administration. Only the worst clinical outcome will be retained as the primary efficacy outcome. The 6 mutually exclusive outcomes ranked from worst to best are: 1.Death (all causes), within 7 days after study treatment administration. 2.Acute myocardial infarction with compromised electro-hemodynamics, within 2 days after study treatment administration. 3.ST-Elevation Myocardial Infarction (STEMI), within 2 days after study treatment administration. 4.High-risk Non-ST-Elevation Myocardial Infarction (NSTEMI), within 2 days after study treatment administration. 5.NSTEMI with peak cardiac troponin greater than 10 times upper limit of normal, within 2 days after study drug administration. 6.None of the above Occurrence of Type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition: The number of: -Type 3 treatment-emergent bleeding events and -Type 5 treatment-emergent bleeding events will be assessed according to the Bleeding Academic Research Consortium (BARC) definition (Mehran et al. 2011), within 2 days after study treatment administration. The Bleeding Academic Research Consortium (BARC) definitions are: -Type 3, bleeding is divided into 3 categories, a through c, and includes clinical, laboratory, and/or imaging evidence of bleeding with specific healthcare provider responses. -Type 5, bleeding is fatal. | — |
Countries
Africa, Asia Pacific, etc., Europe, Japan, Latin America, Participating regions include North America,
Contacts
Public ContactIQVIA Services Japan G.K. jRCT Inquiry Contact
IQVIA Services Japan G.K
Outcome results
None listed