Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

Official 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

Details

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.

Keywords

Acute Myocardial Infarction Platelet Aggregation Inhibitors Myocardial Infarction Infarction Selatogrel

Eligibility

You can join if…

Open to people ages 18 years and up

  • Discharged with a 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.
  • Presence of either a second prior AMI within 1 year of screening or at least 2 of the following risk factors:
  • Second prior AMI more than 1 year before screening.
  • Diabetes mellitus defined by ongoing glucose lowering treatment.
  • Chronic kidney disease with estimated glomerular filtration rate less-than 60 mL/min/1.73 m2.
  • Multivessel coronary artery disease.
  • Peripheral artery disease.
  • Age greater than or equal to 65 years.
  • Absence of coronary revascularization of the qualifying AMI.
  • Active daily smoking at screening.
  • Successful self-administered placebo according to the autoinjector instruction for use training during screening.

You CAN'T join if...

  • 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.

Locations

  • University of California San Diego Medical Center
    La Jolla California 92037 United States
  • Long Beach VA Healthcare System
    Long Beach California 90822 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Idorsia Pharmaceuticals Ltd.
ID
NCT04957719
Phase
Phase 3 Heart Attack Research Study
Study Type
Interventional
Participants
Expecting 14000 study participants
Last Updated