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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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02164864
First received: June 13, 2014
Last updated: January 3, 2017
Last verified: January 2017
  Purpose

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 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 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.


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
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 first International Society of Thrombosis and Haemostasis Major Bleeding Event or Clinically Relevant Non Major Bleeding Event [ Time Frame: up to 30 months ]

Secondary Outcome Measures:
  • Time to event for individual outcome events - Undetermined cause of death [ Time Frame: up to 30 months ]
  • Time to event for individual outcome events - Non-cardiovascular death [ Time Frame: up to 30 months ]
  • Time to event for individual outcome events - Cardiovascular death [ Time Frame: up to 30 months ]
  • Time to event for individual outcome events - All death [ Time Frame: up to 30 months ]
  • Time to event for individual outcome events - Myocardial Infarction [ Time Frame: up to 30 months ]
  • Time to event for individual outcome events - Stroke [ Time Frame: up to 30 months ]
  • Time to event for individual outcome events - SE [ Time Frame: up to 30 months ]
  • Time to event for individual outcome events - Stent Thrombosis [ Time Frame: up to 30 months ]
  • Time to event for the composite endpoint of death + MI + stroke [ Time Frame: up to 30 months ]
  • Time to death or first thrombotic event (all death, myocardial infarction, stroke/systemic embolism) or unplanned revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft [ Time Frame: up to 30 months ]
  • Time to death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)) [ Time Frame: up to 30 months ]
  • Time to event for unplanned revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft [ Time Frame: up to 30 months ]

Estimated Enrollment: 2800
Study Start Date: July 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 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 comparator
Experimental: Dabigatran Etexilate 150mg
Patient to receive Dabigatran Etexilate 150mg BID
Drug: Dabigatran Etexilate 150mg
Active treatment
Drug: Clopidogrel or Ticagrelor
Active comparator
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Show 407 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02164864     History of Changes
Other Study ID Numbers: 1160.186
2013-003201-26 ( EudraCT Number: EudraCT )
Study First Received: June 13, 2014
Last Updated: January 3, 2017

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Clopidogrel
Ticlopidine
Aspirin
Ticagrelor
Dabigatran
Warfarin
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 25, 2017