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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Klinikum der Universitaet Muenchen AöR

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

21 Dec 2021 → 3 Mar 2026

Decision date (initial)

2024-10-20

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Daiichi-Sankyo Deutschland GmbH

External identifiers

EU CT number

2024-512727-36-00

EudraCT number

2020-004748-27

ClinicalTrials.gov

NCT04981041

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The primary study objective is to test whether an escalated antiplatelet therapy with a potent P2Y12-inhibitor (Prasugrel or Ticagrelor) for 4 weeks can reduce ischaemic events without a significant increase in bleeding complications in patients with atrial fibrillation and ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation acute coronary myocardial infarction (NSTEMI (biomarker -positive acute coronary syndrome) undergoing PCI.

Secondary objectives 1

1. The effect of platelet function based on platelet function testing (PFT) on ischaemic and bleeding complications will be investigated in a predefined substudy.

Conditions and MedDRA coding

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Written informed consent
2. Age ≥ 18 years
3. Atrial fibrillation requiring oral anticoagulation
4. STEMI or NSTEMI (biomarker positive acute coronary syndrome)
5. Successful completion of PCI (defined as TIMI flow grade 2 or more; randomization will take place within 5 days (recommended within 24h) after successful PCI and before hospital discharge)

Exclusion criteria 17

1. Chronic renal insufficiency with glomerular filtration rate < 15 ml/min/1.73m2
2. History of ischaemic stroke or transient ischaemic attack (both contraindications for Prasugrel) and history of intracranial bleeding (contraindication for Ticagrelor)
3. Contraindication for Clopidogrel or Aspirin
4. Contraindication for Prasugrel and Ticagrelor
5. Severe chronic liver disease (Child-Pugh C)
6. Indication for oral anticoagulation with Vitamin K antagonists
7. Moderate to severe mitral stenosis or mechanical heart valve
8. Any bleeding BARC type ≥ 2 within the last 4 weeks before index procedure
9. Pregnancy or lactation
10. Inability to cooperate with the protocol requirements
11. Life expectancy < 6 months
12. Participation in another investigational drug study
13. Previous enrolment in this study
14. For women of childbearing potential no negative pregnancy test and no agree to use a reliable method of birth control during the study
15. Previous treatment with GP IIb/IIIa inhibitors within the last 12 hours
16. A known genetic disorder involved in the metabolism of the study medication
17. Any other reason in the opinion of the investigator making the patient ineligible for participation in the trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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
2. 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 endpoints 7

1. 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
2. Cardiovascular mortality at 6 weeks after randomization
3. Bleeding (BARC type ≥ 2) at 6 weeks after randomization
4. Urgent revascularization at 6 weeks after randomization
5. All-cause mortality at 6 months after randomization
6. Unplanned hospitalization due to acute heart failure or acute coronary syndrome at 6 months after randomization
7. Ischaemic stroke at 6 months after randomization

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Klinikum der Universitaet Muenchen AöR

Sponsor organisation

Klinikum der Universitaet Muenchen AöR

Address

Marchioninistrasse 15, Hadern Hadern

City

Munich

Postcode

81377

Country

Germany

Scientific contact point

Organisation

Klinikum der Universitaet Muenchen AöR

Contact name

Sponsor delegated person

Public contact point

Organisation

Klinikum der Universitaet Muenchen AöR

Contact name

Sponsor delegated person

Third parties 2

Locations

2 EU/EEA countries · 18 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 27 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications