Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
- Conditions
- Acute Myocardial Infarction
- Registration Number
- NCT04957719
- Lead Sponsor
- Viatris Innovation GmbH
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 14000
-
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.
Main
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Clinical status as assessed by a 6-point ordinal scale 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 aboveOccurrence of Type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition 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 Outcome Measures
Name Time Method 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 Occurrence death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure within 30 days after any self-administration.
Trial Locations
- Locations (558)
Advanced Cardiovascular, LLC
🇺🇸Alexander City, Alabama, United States
Birmingham VA Health Care System
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Cardiovascular Associates of the Southeast
🇺🇸Birmingham, Alabama, United States
Grandview Medical Center and Affinity Cardiovascular Specialists, LCC
🇺🇸Birmingham, Alabama, United States
Heart Center Research, LLC
🇺🇸Huntsville, Alabama, United States
Dignity Health Mercy Gilbert Medical Center
🇺🇸Gilbert, Arizona, United States
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
University of Arizona - Sarver Heart Center
🇺🇸Tucson, Arizona, United States
Northeast Arkansas Charitable Foundation, Inc.- NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Scroll for more (548 remaining)Advanced Cardiovascular, LLC🇺🇸Alexander City, Alabama, United States