NCT02164864

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,725 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Atrial Fibrillation
• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DRUG	Dabigatran Etexilate 110mg	Active treatment
DRUG	Warfarin 3mg	Active comparator
DRUG	Aspirin	Active comparator
DRUG	Dabigatran Etexilate 150mg	Active treatment
DRUG	Clopidogrel or Ticagrelor	Active comparator
DRUG	Clopidogrel or Ticagrelor	Active comparator
DRUG	Warfarin 5mg	Active comparator
DRUG	Clopidogrel or Ticagrelor	Active comparator
DRUG	Warfarin 1mg	Active comparator

Timeline

• Start date: 2014-07-22
• Primary completion: 2017-06-05
• Completion: 2017-06-05
• First posted: 2014-06-17
• Last updated: 2018-07-31
• Results posted: 2018-07-31

Locations

421 sites across 41 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom