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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505438-85-00
Acronym
ID-076A301
Enrollment
13537
Registered
2024-01-26
Start date
2022-01-12
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myocardial infarction (AMI)

Brief summary

Efficacy: Occurrence of death or non-fatal AMI after any study treatment self-administration. The outcome will be ranked from most to least severe: 1. Death (all causes)* 2. AMI with compromised electro-hemodynamics** 3. STEMI** 4 .High-risk NSTEMI** 5. NSTEMI with peak cardiac troponin > 10 × upper limit of normal** 6. None of the above within *7/**2 days after each treatment administration Only the worst outcome will be retained as the primary endpoint., Safety: Occurrence of type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition, within 2 days after study treatment administration.

Detailed description

Occurrence of death, non-fatal AMI, hospitalization or unplanned emergency department visit for heart failure, within 30 days after any treatment administration (composite endpoint).

Interventions

DRUGSelatogrel solution matching placebo
DRUGSelatogrel solution

Sponsors

Viatris Innovation GmbH
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Efficacy: Occurrence of death or non-fatal AMI after any study treatment self-administration. The outcome will be ranked from most to least severe: 1. Death (all causes)* 2. AMI with compromised electro-hemodynamics** 3. STEMI** 4 .High-risk NSTEMI** 5. NSTEMI with peak cardiac troponin > 10 × upper limit of normal** 6. None of the above within *7/**2 days after each treatment administration Only the worst outcome will be retained as the primary endpoint., Safety: Occurrence of type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition, within 2 days after study treatment administration.

Secondary

MeasureTime frame
Occurrence of death, non-fatal AMI, hospitalization or unplanned emergency department visit for heart failure, within 30 days after any treatment administration (composite endpoint).

Countries

Austria, Belgium, Bulgaria, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026