Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)

Completed · Phase 3

Conditions studied: Atrial Fibrillation, Percutaneous Coronary Intervention

In brief

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 (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 Aspirin (ASA) \<= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome). The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.

Key facts

Study ID

NCT02164864

Run by

Boehringer Ingelheim

People needed

2725

Starts

2014-07-22

Expected to finish

2017-06-05

Last updated by the study team

2018-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients aged >=18 years
• Patients with Non Valvular Atrial Fibrillation
• Patient presenting with:
• An Acute Coronary Syndrome (ACS) (ST elevation myocardial infarction (STEMI), NonSTEMI [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either Bare Metal Stent (BMS) 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.

You may not qualify if…

• 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 Creatinine Clearance (CrCl) calculated by Cockcroft-Gault equation) <30mL/min at screening
• Active liver disease

Where it is running

• Verde Valley Medical Center — Cottonwood, Arizona, United States
• Cardiovascular Associates of Mesa — Mesa, Arizona, United States
• HonorHealth Research Institute — Scottsdale, Arizona, United States
• Arkansas Cardiology, PA — Little Rock, Arkansas, United States
• Mission Cardiovascular Research Institute — Fremont, California, United States
• Aurora Denver Cardiology Associates, PC — Aurora, Colorado, United States
• University of Florida College of Medicine — Jacksonville, Florida, United States
• Watson Clinic, LLP — Lakeland, Florida, United States
• Community Clinical Research Center — Anderson, Indiana, United States
• Midwest Cardiovascular Research and Education Foundation — Elkhart, Indiana, United States
• Ball Memorial Hospital — Muncie, Indiana, United States
• Richmond Cardiology Associates Research, LLC — Richmond, Indiana, United States
• Cardiovascular Institute of the South — Houma, Louisiana, United States
• Maine Medical Center — Portland, Maine, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Cape Cod Research Institute — Hyannis, Massachusetts, United States
• Mid Michigan Medical Center — Midland, Michigan, United States
• Covenant Medical Center, Inc. — Saginaw, Michigan, United States
• Saint Mary's Medical Center dba Essentia Health Saint Mary's Medical Center — Duluth, Minnesota, United States
• CentraCare Heart and Vascular Center — Saint Cloud, Minnesota, United States
• Kansas City Veterans Administration Medical Center — Kansas City, Missouri, United States
• Saint Anthony's Medical Center — St Louis, Missouri, United States
• St. Michaels Medical Center — Newark, New Jersey, United States
• Cardiology P.C. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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