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

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

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

Sponsors & Collaborators

• Boehringer Ingelheim

  lead INDUSTRY

Principal Investigators

• Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-07-22

Primary Completion

2017-06-05

Completion

2017-06-05

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

Study Locations