Evaluation of Dual Therapy with Dabigatran versus Triple Therapy with Warfarin in Patients with Atrial Fibrillation that Undergo a Percutaneous Coronary Intervention with Stenting (REDUAL-PCI)

Overview

About this study

The main objective of this study is to compare a dual antithrombotic therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel,or ticagrelor 110mg dabigatran etexilate dual antithrombotic therapy (DE-DAT), and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a triple antithrombotic therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus ASA ≤ 100mg q.d. (warfarin-TAT) in patients with atrial fibrillation that undergo a percutaneous coronary intervention with stenting (elective or due to an acute coronary syndrome).

The study aims to show non-inferiority of both doses of DE-DAT when compared to Warfarin-TAT in efficacy and safety. Efficacy will be determined by comparing a composite death and thrombotic event rate of death, myocardial infarction, stroke and systemic embolism. In addition, comparisons will be made of the rates of clinically relevant bleeding, assessed using the modified International Society of Thrombosis and Haemostasis (ISTH) major classification.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion criteria:

  • Male or female patients aged >=18 years
  • Patients with Non Valvular Atrial Fibrillation
  • Patient presenting with:

An ACS (STEMI, NonSTEMI [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either Bare Metal Stent or Drug Eluting Stent) Or Stable Coronary Artery Disease with at least one lesion eligible for PCI that was successfully treated by elective PCI and stenting (either BMS or DES)

  • The patient must be able to give informed consent in accordance with International Conference on Harmonisation Good Clinical Practice guidelines and local legislation and/or regulations.

Exclusion criteria:

  • Patients with a mechanical or biological heart valve prosthesis
  • Cardiogenic shock during current hospitalisation
  • Stroke within 1 month prior to screening visit
  • Patients who have had major surgery within the month prior to screening
  • Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated
  • Major bleeding episode including life-threatening bleeding episode in one month prior to screening visit
  • Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count <100 x 109/L) at screening
  • Severe renal impairment (estimated CrCl calculated by Cockcroft-Gault equation) <30mL/min at screening
  • Active liver disease

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

F Fortuin, M.D.

Closed for enrollment

More information

Publications

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