General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT04957719

Background Information

The primary objective of the study is to assess the clinical efficacy 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.

For more information, please visit: https://clinicaltrials.gov/study/NCT04957719

Offered At

Inova Fairfax Medical Center 
3300 Gallows Rd  
Falls Church, VA, 22042
Principal Investigator

Jared Spitz, MD

Eligibility Information

1. Confirmed diagnosis of symptomatic type 1 AMI (STEMI or NSTEMI2), no longer than 4 weeks prior to randomization.

2. 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 < 60 mL/min/1.73 m2
  • Peripheral artery disease defined as any of the following at any time prior to randomization:
    • Ankle/brachial index < 0.85.
    • Amputation, peripheral bypass, or peripheral angioplasty of the extremities secondary to ischemia.
  • Absence of, or unsuccessful coronary revascularization of the qualifying AMI referred to in inclusion criterion 3.

3. Subject having successfully self-administered placebo according to the autoinjector IFU during screening.

4. Women of childbearing potential, must fulfill the following criteria:

  • Negative pregnancy test (urine or serum) during screening.
  • Agreement to use an acceptable contraceptive method as described in Section 6.5.2 from screening up to the FSV.

Ineligibility Information

1. 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.
  • Subjects on oral triple antithrombotic therapy (i.e., dual antiplatelet therapy and oral anticoagulant).
  • Known liver impairment significantly affecting the hepatic function (e.g., ascites, icterus, signs of coagulopathy).
  • Current dialysis.
  • For all countries, except Finland: Ischemic stroke or transient ischemic attack within 3 months prior to screening.

2. Chronic anemia with hemoglobin < 10 g/dL.

3. Chronic thrombocytopenia with platelet count < 100,000/mm3

4. Known hypersensitivity to selatogrel, any of its excipients, or drugs of the P2Y12 class.