Selatogrel Outcome Study in Suspected Acute Myocardial Infarction (SOS-AMI)

Idorsia Pharmaceuticals

Status and phase: Invitation-only; Phase 3

Conditions: Acute Myocardial Infarction

Treatments: Combination Product: Placebo; Combination Product: Selatogrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04957719

2020-000983-41 (EudraCT Number)

ID-076A301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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 m2,
  • 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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14,000 participants in 2 patient groups, including a placebo group

Selatogrel

Experimental group

Description:

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.

Treatment:

Combination Product: Selatogrel

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Combination Product: Placebo