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

Use our guide to learn which trials are right for you!

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
46
sites
1782 Avenida Belgrano
Caba, C1093
5387
mi
from 43215
Caba,
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
643
mi
from 43215
Boston, MA
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
643
mi
from 43215
Boston, MA
Click here to add this to my saved trials
860 South Columbia Road
Grand Forks, North Dakota 58201
701-780-1750
886
mi
from 43215
Grand Forks, ND
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
333
mi
from 43215
Nashville, TN
Click here to add this to my saved trials
22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
704
mi
from 43215
Portland, ME
Click here to add this to my saved trials
Anderson, Indiana 46011
140
mi
from 43215
Anderson, IN
Click here to add this to my saved trials
Aurora, Colorado 80012
1154
mi
from 43215
Aurora, CO
Click here to add this to my saved trials
Birmingham, Alabama 35211
495
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
Buffalo, New York 14215
294
mi
from 43215
Buffalo, NY
Click here to add this to my saved trials
Chambersburg, Pennsylvania 17201
283
mi
from 43215
Chambersburg, PA
Click here to add this to my saved trials
Charlotte, North Carolina 28204
349
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
Chattanooga, Tennessee 37404
362
mi
from 43215
Chattanooga, TN
Click here to add this to my saved trials
Cottonwood, Arizona 86326
1625
mi
from 43215
Cottonwood, AZ
Click here to add this to my saved trials
4500 S. Lancaster Rd.
Dallas, Texas 75216
800-849-3597
Dallas VA Medical Center VA North Texas Health Care System (VANTHCS) is a progressive health...
911
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
654
mi
from 43215
Duluth, MN
Click here to add this to my saved trials
194
mi
from 43215
Elkhart, IN
Click here to add this to my saved trials
2088
mi
from 43215
Fremont, CA
Click here to add this to my saved trials
Harrisburg, Pennsylvania 17011
322
mi
from 43215
Harrisburg, PA
Click here to add this to my saved trials
Houma, Louisiana 70360
838
mi
from 43215
Houma, LA
Click here to add this to my saved trials
Hyannis, Massachusetts 02601
675
mi
from 43215
Hyannis, MA
Click here to add this to my saved trials
Jackson, Tennessee 38301
436
mi
from 43215
Jackson, TN
Click here to add this to my saved trials
Jacksonville, Florida 32209
670
mi
from 43215
Jacksonville, FL
Click here to add this to my saved trials
616
mi
from 43215
Kansas City, MO
Click here to add this to my saved trials
Lakeland, Florida 33805
826
mi
from 43215
Lakeland, FL
Click here to add this to my saved trials
Little Rock, Arkansas 72205
624
mi
from 43215
Little Rock, AR
Click here to add this to my saved trials
1650 South 41st Street
Manitowoc, Wisconsin 54220
371
mi
from 43215
Manitowoc, WI
Click here to add this to my saved trials
McKinney, Texas 75069
885
mi
from 43215
McKinney, TX
Click here to add this to my saved trials
Mesa, Arizona 85206
1645
mi
from 43215
Mesa, AZ
Click here to add this to my saved trials
Midland, Michigan 48670
261
mi
from 43215
Midland, MI
Click here to add this to my saved trials
Muncie, Indiana 47303
125
mi
from 43215
Muncie, IN
Click here to add this to my saved trials
Newark, New Jersey 07102
468
mi
from 43215
Newark, NJ
Click here to add this to my saved trials
600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
422
mi
from 43215
Norfolk, VA
Click here to add this to my saved trials
320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
162
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
1100 Reid Parkway
Richmond, Indiana 47374
98
mi
from 43215
Richmond, IN
Click here to add this to my saved trials
Round Rock, Texas 78665
1047
mi
from 43215
Round Rock, TX
Click here to add this to my saved trials
Saginaw, Michigan 48602
243
mi
from 43215
Saginaw, MI
Click here to add this to my saved trials
1406 6th Avenue North
Saint Cloud, Minnesota 56303
684
mi
from 43215
Saint Cloud, MN
Click here to add this to my saved trials
Saint Louis, Missouri 63128
394
mi
from 43215
Saint Louis, MO
Click here to add this to my saved trials
Salt Lake City, Utah 84132
1511
mi
from 43215
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78299
1136
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
Scottsdale, Arizona 85258
1650
mi
from 43215
Scottsdale, AZ
Click here to add this to my saved trials
Toledo, Ohio 43608
119
mi
from 43215
Toledo, OH
Click here to add this to my saved trials
1708 Old Donation Parkway
Virginia Beach, Virginia 23454
434
mi
from 43215
Virginia Beach, VA
Click here to add this to my saved trials
Voorhees, New Jersey 08043
425
mi
from 43215
Voorhees, NJ
Click here to add this to my saved trials
1631 11th Street
Wichita Falls, Texas 76301
950
mi
from 43215
Wichita Falls, TX
Click here to add this to my saved trials