Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Self-administered Subcutaneous Selatogrel for Prevention of All-cause Death and Treatment of Acute Myocardial Infarction in Subjects With a Recent History of Acute Myocardial Infarction
Overview
- Phase
- Phase 3
- Intervention
- Selatogrel
- Conditions
- Acute Myocardial Infarction
- Sponsor
- Viatris Innovation GmbH
- Enrollment
- 14000
- Locations
- 1301
- Primary Endpoint
- Clinical status as assessed by a 6-point ordinal scale
- Status
- Enrolling by Invitation
- Last Updated
- 2 months ago
Overview
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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion 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, 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
- •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/mm
Arms & Interventions
Selatogrel
Study treatment administration may occur at any time between the randomization visit and the final study visit when the participant experiences symptoms suggestive of an acute myocardial infarction. Study treatment administration triggers protocol pre-defined assessments or visits.
Intervention: Selatogrel
Placebo
Study treatment administration may occur at any time between the randomization visit and the final study visit when the participant experiences symptoms suggestive of an acute myocardial infarction. Study treatment administration triggers protocol pre-defined assessments or visits.
Intervention: Placebo
Outcomes
Primary Outcomes
Clinical status as assessed by a 6-point ordinal scale
Time Frame: Total duration: up to 7 days
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
Time Frame: Total duration: up to 2 days
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.
Secondary Outcomes
- Occurrence of death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure (Composite endpoint)(Total duration: up to 30 days)