Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

Overview

About this study

The primary objective of the study is to assess the clinical effectiveness of selatogrel when self-administered upon occurrence of symptoms suggestive of an acute myocardial infarction (AMI) in subjects at risk of having a recurrent AMI.

The secondary objective is to assess the safety of self-administration of selatogrel.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 or on the left main artery during a prior cardiac catheterization or cardiac catheterization during the qualifying AMI event and
presence of at least 2 of the following risk factors:

- Second prior AMI,

- Diabetes mellitus defined by ongoing glucose lowering treatment,

- Chronic kidney disease with estimated glomerular filtration rate less-than 60 mL/min/1.73 m^2,

- 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/mm^3.

- 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/17/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

F Fortuin, M.D.

Open for enrollment

Contact information:

Carla Owen R.N.

(480) 342-6750

Owen.Carla@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20537932

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