Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Research type
Research Study
Full title
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
IRAS ID
299683
Contact name
Christelle Boniface
Contact email
Sponsor organisation
Viatris Innovation GmbH
Eudract number
2020-000983-41
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
3 years, 11 months, 11 days
Research summary
Most heart attacks are caused by blood clots forming in the blood vessels that supply the heart muscle. Small cells in the blood called platelets are responsible for forming these blood clots. Selatogrel is an injectable drug that temporarily prevents platelets from causing blood clots and is not yet approved for use in any country. Patients with a recent heart attack will be invited to take part in this study, which will investigate the effectiveness and safety of selatogrel. Participants will be instructed to self-administer the study drug (selatogrel or placebo) by injecting themselves in their thigh or abdomen when they feel symptoms of a heart attack. Previous clinical studies have assessed the effects of injected selatogrel but this is the first time that self-administration of selatogrel is being tested.
About 14,000 patients will take part in about 800 hospitals in about 40 countries worldwide. About 8 UK hospitals with specialist cardiology departments will be inviting patients to participate in the study.
A patient could be in the study from 6 months up to 4 years, depending on when they were recruited.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
21/EE/0190
Date of REC Opinion
13 Sep 2021
REC opinion
Further Information Favourable Opinion