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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
First received: June 13, 2014
Last updated: January 26, 2016
Last verified: January 2016

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 Dual Antithrombotic Therapy (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 ASA <= 100mg q.d. (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome (ACS)).

The study aims to show non-inferiority of both doses of DE-DAT when compared to Warfarin-TAT in efficacy and safety. Efficacy will be determined by comparing a composite death and thrombotic event rate of death, myocardial infarction, stroke and systemic embolism. In addition, comparisons will be made of the rates of clinically relevant bleeding, assessed using the modified International Society of Thrombosis and Haemostasis (ISTH) major classification.

Condition Intervention Phase
Atrial Fibrillation
Percutaneous Coronary Intervention
Drug: Dabigatran Etexilate 110mg
Drug: Warfarin 3mg
Drug: Aspirin
Drug: Dabigatran Etexilate 150mg
Drug: Clopidogrel or Ticagrelor
Drug: Warfarin 5mg
Drug: Warfarin 1mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Time to death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)) [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to first International Society of Thrombosis and Haemostasis Major Bleeding Event [ Time Frame: up to 30 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to event for individual outcome events - Undetermined cause of death [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to event for individual outcome events - Non-cardiovascular death [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to event for individual outcome events - Cardiovascular death [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to event for individual outcome events - All death [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to event for individual outcome events - Myocardial Infarction [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to event for individual outcome events - Stroke [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to event for individual outcome events - SE [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to event for individual outcome events - Stent Thrombosis [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to event for the composite endpoint of death + MI + stroke [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to event for repeated revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 8520
Study Start Date: July 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dabigatran Etexilate 110mg
Patient to receive Dabigatran Etexilate 110mg BID
Drug: Dabigatran Etexilate 110mg
Active treatment
Drug: Clopidogrel or Ticagrelor
Active treatment
Experimental: Dabigatran Etexilate 150mg
Patient to receive Dabigatran Etexilate 150mg BID
Drug: Dabigatran Etexilate 150mg
Active treatment
Drug: Clopidogrel or Ticagrelor
Active treatment
Active Comparator: Warfarin
Warfarin doses to maintain INR
Drug: Warfarin 3mg
Active comparator
Drug: Aspirin
Active comparator
Drug: Clopidogrel or Ticagrelor
Active comparator
Drug: Warfarin 5mg
Active comparator
Drug: Warfarin 1mg
Active comparator


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Male or female patients aged >=18 years
  • Patients with Non Valvular Atrial Fibrillation
  • Patient presenting with:

An ACS (STEMI, NonSTEMI [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either Bare Metal Stent 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 CrCl calculated by Cockcroft-Gault equation) <30mL/min at screening
  • Active liver disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02164864

Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Show 600 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02164864     History of Changes
Other Study ID Numbers: 1160.186  2013-003201-26 
Study First Received: June 13, 2014
Last Updated: January 26, 2016
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Austrian Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Brazil: Ministry of Health
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
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Czech Republic: State Institute for Drug Control
Denmark: The Danish Health and Medicines Authority
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Greece: Ethics Committee
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Hungary: National Institute of Pharmacy
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Italy: AIFA (Italian Medicine Agency)
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Korea: Ministry of Food and Drug Safety
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New Zealand: Medsafe
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Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
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Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Cardiovascular Agents
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protease Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Serine Proteinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on February 07, 2016