Dual Antithrombotic Therapy With Dabigatran and Ticagrelor in Patients With ACS and Non-valvular AF Undergoing PCI

PHASE4RecruitingINTERVENTIONAL
Enrollment

2,230

Participants

Timeline

Start Date

October 25, 2021

Primary Completion Date

March 1, 2024

Study Completion Date

March 31, 2026

Conditions
Atrial FibrillationAntithrombotic TherapyAcute Coronary SyndromePercutaneous Coronary Interventions
Interventions
DRUG

Ticagrelor

Within 72 hours post PCI, patients will be randomized in a 1:1 ratio to receive one of the two treatments: dual therapy with ticagrelor (90 mg twice daily for one month, followed by 60 mg twice daily up to 12 months) plus dabigatran (150 mg twice daily or 110 mg twice daily; standard of care) or triple therapy with clopidogrel (75 mg once daily) plus aspirin (75 mg once daily) plus dabigatran (150 mg twice daily or 110 mg twice daily), according to current guidelines. Study treatment will be continued for 12 months.

DRUG

Dabigatran Etexilate

Within 72 hours post PCI, patients will be randomized in a 1:1 ratio to receive one of the two treatments: dual therapy with ticagrelor (90 mg twice daily for one month, followed by 60 mg twice daily up to 12 months) plus dabigatran (150 mg twice daily or 110 mg twice daily; standard of care) or triple therapy with clopidogrel (75 mg once daily) plus aspirin (75 mg once daily) plus dabigatran (150 mg twice daily or 110 mg twice daily), according to current guidelines. Study treatment will be continued for 12 months

DRUG

Aspirin

Within 72 hours post PCI, patients will be randomized in a 1:1 ratio to receive one of the two treatments: dual therapy with ticagrelor (90 mg twice daily for one month, followed by 60 mg twice daily up to 12 months) plus dabigatran (150 mg twice daily or 110 mg twice daily; standard of care) or triple therapy with clopidogrel (75 mg once daily) plus aspirin (75 mg once daily) plus dabigatran (150 mg twice daily or 110 mg twice daily), according to current guidelines. Study treatment will be continued for 12 months

DRUG

Clopidogrel

Within 72 hours post PCI, patients will be randomized in a 1:1 ratio to receive one of the two treatments: dual therapy with ticagrelor (90 mg twice daily for one month, followed by 60 mg twice daily up to 12 months) plus dabigatran (150 mg twice daily or 110 mg twice daily; standard of care) or triple therapy with clopidogrel (75 mg once daily) plus aspirin (75 mg once daily) plus dabigatran (150 mg twice daily or 110 mg twice daily), according to current guidelines. Study treatment will be continued for 12 months

Trial Locations (1)

80-214

RECRUITING

Cardiac lntensive Care Unit, First Department of Cardiology, University Clinical Centre in Gdańsk, Gdansk

All Listed Sponsors
collaborator

Medical University of Warsaw

OTHER

collaborator

Nicolaus Copernicus University

OTHER

collaborator

National Institute of Cardiology, Warsaw, Poland

OTHER

collaborator

Military Institute od Medicine National Research Institute

OTHER

collaborator

Bielanski Hospital

OTHER

collaborator

Medical University of Silesia

OTHER

collaborator

Poznan University of Medical Sciences

OTHER

collaborator

University of Opole, Poland

UNKNOWN

collaborator

Medical University of Łódź

OTHER

collaborator

Voivodeship Hospital, Kielce, Poland

UNKNOWN

collaborator

Voivode Specialist Hospital in Olsztyn, Poland

UNKNOWN

collaborator

Medical University of Lublin

OTHER

collaborator

Pomeranian Medical University Szczecin

OTHER

collaborator

Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

OTHER

lead

Medical University of Gdansk

OTHER

NCT04695106 - Dual Antithrombotic Therapy With Dabigatran and Ticagrelor in Patients With ACS and Non-valvular AF Undergoing PCI | Biotech Hunter | Biotech Hunter