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
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:
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)
Exclusion criteria:
Duluth, Minnesota 55805, United States
Virginia Beach, Virginia 23454, United States
CABA, C1093AAS, Argentina
CABA, C1199ABB, Argentina
CABA, C1428DCO, Argentina
Capital Federal, C1425AGC, Argentina
Middelheim, 2020, Belgium
Ste-Foy, Quebec GLV 4G5, Canada
Århus N, 8200, Denmark
Bad Friedrichshall, 74177, Germany
Homburg/Saar, 66421, Germany
Seemandhra, 530002, India
Aichi, Nagoya, 466-8650, Japan
Aomori, Hirosaki, 036-8563, Japan
Chiba, Chiba, 260-8677, Japan
Fukuoka, Kitakyushu, 802-8555, Japan
Fukuoka, Koga, 811-3195, Japan
Fukuoka, Kurume, 830-8577, Japan
Hiroshima, Fukuyama, 720-0804, Japan
Hyogo, Himeji, 670-0981, Japan
Hyogo, Kawanishi, 666-0125, Japan
Hyogo, Kobe, 650-0017, Japan
Hyogo, Kobe, 654-0026, Japan
Ishikawa, Kanazawa, 920-8650, Japan
Iwate, Morioka, 020-8505, Japan
Kagawa, Takamatsu, 760-8557, Japan
Kanagawa, Fujisawa, 251-0041, Japan
Kanagawa, Sagamihara, 252-0375, Japan
Kanagawa, Yokohama, 231-8682, Japan
Kyoto, Kyoto, 606-8507, Japan
Miyazaki, Miyazaki, 880-0834, Japan
Osaka, Osaka, 530-0001, Japan
Osaka, Osaka, 534-0021, Japan
Saitama, Sayama, 350-1305, Japan
Saitama, Wako, 351-0102, Japan
Shiga, Kusatsu, 525-8585, Japan
Shiga, Omihachiman, 523-0082, Japan
Tokushima, Komatsushima, 773-8502, Japan
Tokyo, Bunkyo-ku, 113-8603, Japan
Tokyo, Hachioji, 192-0918, Japan
Zapopan, Jalisco, 45040, Mexico
L'Hospitalet Llobregat (bcn), 08907, Spain
Vizcaya, 48960, Spain