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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04957719
Registration number
NCT04957719
Ethics application status
Date submitted
28/06/2021
Date registered
12/07/2021
Titles & IDs
Public title
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
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Scientific 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
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Secondary ID [1]
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2020-000983-41
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Secondary ID [2]
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ID-076A301
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Universal Trial Number (UTN)
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Trial acronym
SOS-AMI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Selatogrel
Other interventions - Placebo
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.
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.
Other interventions: 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 interventions: 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Clinical status as assessed by a 6-point ordinal scale
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Assessment method [1]
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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
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Timepoint [1]
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Total duration: up to 7 days
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Primary outcome [2]
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Occurrence of Type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition
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Assessment method [2]
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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.
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Timepoint [2]
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Total duration: up to 2 days
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Secondary outcome [1]
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Occurrence of death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure (Composite endpoint)
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Assessment method [1]
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Occurrence death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure within 30 days after any self-administration.
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Timepoint [1]
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Total duration: up to 30 days
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Eligibility
Key inclusion criteria
Main
* 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/08/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
13/08/2025
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Actual
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Sample size
Target
14000
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Accrual to date
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Final
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Tiel
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Belgrade
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Niš
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Bern
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Lugano
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Songkhla
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Cambridge
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United Kingdom
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Londonderry
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United Kingdom
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Newcastle
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United Kingdom
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North Shields
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United Kingdom
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Portadown
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United Kingdom
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Sheffield
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United Kingdom
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Stevenage
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Idorsia Pharmaceuticals Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04957719
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Trial related presentations / publications
Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available. Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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0
Idorsia Pharmaceuticals Ltd.
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0
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Phone
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04957719