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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04957719
Recruitment Status : Enrolling by invitation
First Posted : July 12, 2021
Last Update Posted : September 8, 2022
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Tracking Information
First Submitted Date  ICMJE June 28, 2021
First Posted Date  ICMJE July 12, 2021
Last Update Posted Date September 8, 2022
Actual Study Start Date  ICMJE August 14, 2021
Estimated Primary Completion Date August 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2021)
  • Clinical status as assessed by a 6-point ordinal scale [ Time Frame: Total duration: up to 7 days ]
    The clinical status will be assessed using a 6-point ordinal scale after any study treatment self-administration. Only the worst clinical outcome will be retained as the primary efficacy outcome. The 6 mutually exclusive outcomes ranked from worst to best are:
    1. Death (all causes), within 7 days after study treatment administration.
    2. Acute myocardial infarction with compromised electro-hemodynamics, within 2 days after study treatment administration.
    3. ST-Elevation Myocardial Infarction (STEMI), within 2 days after study treatment administration.
    4. High-risk Non-ST-Elevation Myocardial Infarction (NSTEMI), within 2 days after study treatment administration.
    5. NSTEMI with peak cardiac troponin greater than 10 times upper limit of normal, within 2 days after study drug administration.
    6. None of the above
  • Occurrence of Type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition [ Time Frame: Total duration: up to 2 days ]
    The number of:
    • Type 3 treatment-emergent bleeding events and
    • Type 5 treatment-emergent bleeding events
    will be assessed according to the Bleeding Academic Research Consortium (BARC) definition (Mehran et al. 2011), within 2 days after study treatment administration. The Bleeding Academic Research Consortium (BARC) definitions are:
    • Type 3, bleeding is divided into 3 categories, a through c, and includes clinical, laboratory, and/or imaging evidence of bleeding with specific healthcare provider responses.
    • Type 5, bleeding is fatal.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2021)
Occurrence of death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure (Composite endpoint) [ Time Frame: Total duration: up to 30 days ]
Occurrence death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure within 30 days after any self-administration.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Official Title  ICMJE 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
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE
  • Combination Product: Selatogrel

    Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. Selatogrel will be administered as a liquid formulation in a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system.

    Participants will self-administer 16 mg of selatogrel subcutaneously with the autoinjector upon occurrence of symptoms suggestive of an acute myocardial infarction. Self-administration encompasses the use of the autoinjector by another person (e.g., partner, close relative, friend, caregiver) who may be called for help during the emergency situation of a suspected AMI.

    Other Name: ACT-246475
  • Combination Product: Placebo

    Placebo will be administered as a liquid formulation in a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system.

    Participants will self-administer placebo subcutaneously with the autoinjector upon occurrence of symptoms suggestive of an acute myocardial infarction. Self-administration encompasses the use of the autoinjector by another person (e.g., partner, close relative, friend, caregiver) who may be called for help during the emergency situation of a suspected AMI.

Study Arms  ICMJE
  • Experimental: Selatogrel
    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.
    Intervention: Combination Product: Selatogrel
  • Placebo Comparator: Placebo
    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.
    Intervention: Combination Product: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 7, 2021)
14000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2025
Estimated Primary Completion Date August 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Main Inclusion Criteria:

  • 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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Bulgaria,   Canada,   Czechia,   Denmark,   Estonia,   Finland,   France,   Germany,   Hungary,   Ireland,   Israel,   Italy,   Lithuania,   Netherlands,   Norway,   Poland,   Romania,   Serbia,   Slovakia,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04957719
Other Study ID Numbers  ICMJE ID-076A301
2020-000983-41 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Idorsia Pharmaceuticals Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Idorsia Pharmaceuticals Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Idorsia Pharmaceuticals
PRS Account Idorsia Pharmaceuticals Ltd.
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP