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Escalated single Platelet Inhibition for one month plus Direct oral anticoagulation in patients with Atrial fibrillation and acUte coRonary syndrome undergoing percutaneoUS coronary intervention (EPIDAURUS)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512727-36-00
Acronym
EPIDAURUS-2020
Enrollment
1474
Registered
2024-10-11
Start date
2021-12-21
Completion date
Unknown
Last updated
2025-08-22

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

Conditions

Patients with atrial fibrillation and ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) (biomarker -positive acute coronary syndrome) undergoing PCI

Brief summary

Primary efficacy endpoint: Major ischaemic events defined as the composite of all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke or systemic thromboembolism (superiority test) at 6 weeks after randomization, Primarys safety endpoint: Bleeding type 2 or higher according to the Bleeding Academic Research Consortium (BARC) criteria (non-inferiority test) at 6 weeks after randomization

Detailed description

All individual components of the primary endpoint (all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke, systemic thromboembolism) at 6 weeks after randomization, Cardiovascular mortality at 6 weeks after randomization, Bleeding (BARC type ≥ 2) at 6 weeks after randomization, Urgent revascularization at 6 weeks after randomization, All-cause mortality at 6 months after randomization, Unplanned hospitalization due to acute heart failure or acute coronary syndrome at 6 months after randomization, Ischaemic stroke at 6 months after randomization

Interventions

DRUGACETYLSALICYLIC ACID
DRUGPRASUGREL
DRUGTICAGRELOR
DRUGCLOPIDOGREL

Sponsors

Klinikum der Universitaet Muenchen AöR
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Primary efficacy endpoint: Major ischaemic events defined as the composite of all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke or systemic thromboembolism (superiority test) at 6 weeks after randomization, Primarys safety endpoint: Bleeding type 2 or higher according to the Bleeding Academic Research Consortium (BARC) criteria (non-inferiority test) at 6 weeks after randomization

Secondary

MeasureTime frame
All individual components of the primary endpoint (all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke, systemic thromboembolism) at 6 weeks after randomization, Cardiovascular mortality at 6 weeks after randomization, Bleeding (BARC type ≥ 2) at 6 weeks after randomization, Urgent revascularization at 6 weeks after randomization, All-cause mortality at 6 months after randomization, Unplanned hospitalization due to acute heart failure or acute coronary syndrome at 6 months after randomization, Ischaemic stroke at 6 months after randomization

Countries

Austria, Germany

Outcome results

None listed

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