Selatogrel Outcome Study in Suspected Acute Myocardial In... | NCT04957719

NCT04957719

ID	Type	Description	Link
2023-505438-85-00	EU Trial (CTIS) Number
2020-000983-41	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Selatogrel	Experimental	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.	Combination Product: Selatogrel
Placebo	Placebo Comparator	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.	Combination Product: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Selatogrel	Combination Product	Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. Selatogrel will be administered as a liquid formulation in a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system. Participants will self-administer 16 mg of selatogrel subcutaneously with the autoinjector upon occurrence of symptoms suggestive of an acute myocardial infarction. Self-administration encompasses the use of the autoinjector by another person (e.g., partner, close relative, friend, caregiver) who may be called for help during the emergency situation of a suspected AMI.

Outcomes Module

Primary Outcomes

Measure	Description	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: Death (all causes), within 7 days after study treatment administration. Acute myocardial infarction with compromised electro-hemodynamics, within 2 days after study treatment administration. ST-Elevation Myocardial Infarction (STEMI), within 2 days after study treatment administration. High-risk Non-ST-Elevation Myocardial Infarction (NSTEMI), within 2 days after study treatment administration. NSTEMI with peak cardiac troponin greater than 10 times upper limit of normal, within 2 days after study drug administration. None of the above	Total duration: up to 7 days
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.	Total duration: up to 2 days

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure (Composite endpoint)	Occurrence death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure within 30 days after any self-administration.	Total duration: up to 30 days

Eligibility Module

Eligibility 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, 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 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.

Name	Affiliation	Role
Clinical Trials	Viatris Innovation GmbH	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Advanced Cardiovascular, LLC		Alexander City	Alabama	35010	United States
Birmingham VA Health Care System

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30153967	Background	Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available.
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