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



Status:Completed
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:8/2/2018
Start Date:July 22, 2014
End Date:June 5, 2017

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A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate (110mg and 150mg b.i.d.) Plus Clopidogrel or Ticagrelor vs. Triple Therapy Strategy With Warfarin (INR 2.0 - 3.0) Plus Clopidogrel or Ticagrelor and Aspirin in Patients With Non Valvular Atrial Fibrillation (NVAF) That Have Undergone a Percutaneous Coronary Intervention (PCI) With Stenting

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.


Inclusion criteria:

- 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.

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

- Active liver disease
We found this trial at
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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75 Francis street
Boston, Massachusetts 02115
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860 South Columbia Road
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1211 Medical Center Dr
Nashville, Tennessee 37232
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22 Bramhall St
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Cottonwood, Arizona 86326
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4500 S. Lancaster Rd.
Dallas, Texas 75216
800-849-3597
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600 Gresham Dr
Norfolk, Virginia 23507
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320 E North Ave
Pittsburgh, Pennsylvania 15212
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Richmond, Indiana 47374
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