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Trial record 1 of 1 for:    NCT02164864
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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)

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ClinicalTrials.gov Identifier: NCT02164864
Recruitment Status : Completed
First Posted : June 17, 2014
Results First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief 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.


Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2725 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : July 22, 2014
Actual Primary Completion Date : June 5, 2017
Actual Study Completion Date : June 5, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Dabigatran Etexilate 110mg
Patient to receive Dabigatran Etexilate 110mg twice a day (BID)
 Drug: Dabigatran Etexilate 110mg
Active treatment

Drug: Clopidogrel or Ticagrelor
Active comparator
Experimental: Dabigatran Etexilate 150mg
Patient to receive Dabigatran Etexilate 150mg twice a day (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


Outcome Measures
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Primary Outcome Measures :
  1. Time to First Adjudicated ISTH MBE or CRNMBE [ Time Frame: up to 30 months ]

    Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported.

    Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation period for this analysis set was the date of randomisation. Patients who discontinued trial medication were followed until the end of the trial.

    Patients who were lost to follow-up for vital status were censored for the primary endpoint at the time of their last known vital status.

    Intention to treat period: The observation period for these analysis was the so called 'intention to treat period'.



Secondary Outcome Measures :
  1. Time to Adjudicated Undetermined Cause of Death [ Time Frame: up to 30 months ]

    Time to event analysis of patients with adjudicated Undetermined cause of death. The number of observed patients with adjudicated Undetermined cause of death was reported.

    This is referred to a death not attributable to cardiovascular (CV) death or to a non-cardiovascular (non-CV) cause. Inability to classify the cause of death may have been due to lack of information (e.g. the only available information was "patient died") or when there was insufficient supporting information or detail to assign the cause of death.


  2. Time to Adjudicated Non-CV [ Time Frame: up to 30 months ]

    Time to event analysis of patients with adjudicated Non-cardiovascular (Non-CV). The number of observed patients with adjudicated Non-CV was reported.

    Non-CV death was defined as any death with a specific cause that was not thought to be CV. These were possible examples of non-CV causes of death: Pulmonary, Renal, Gastrointestinal, Hepatobiliary, Pancreatic Infection(included sepsis), Inflammatory (e.g. systemic inflammatory response syndrome) or immune (including autoimmune), Haemorrhage that was neither CV bleeding nor a stroke, Non-CV procedure or surgery, Trauma, Suicide, Non-prescription drug reaction or overdose, Prescription drug reaction or overdose, Neurological (non-CV), Malignancy, Other non-CV


  3. Time to Adjudicated CV [ Time Frame: up to 30 months ]

    Time to event analysis of patients with adjudicated Cardiovascular (CV) death. The number of observed patients with adjudicated Cardiovascular (CV) death was reported.

    CV death included death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to CV procedures, death due to CV haemorrhage, and death due to other CV causes.


  4. Time to Adjudicated All Cause Death [ Time Frame: up to 30 months ]
    Time to event analysis of patients with adjudicated all cause death. The number of observed patients with adjudicated all cause death was reported. All cause death is defined as the death from any cause included CV death, non-CV death, and undetermined cause of death.

  5. Time to First Adjudicated MI [ Time Frame: up to 30 months ]
    Time to event analysis of patients with first adjudicated Myocardial Infarction (MI). The number of observed patients with adjudicated MI was reported

  6. Time to First Adjudicated Stroke [ Time Frame: up to 30 months ]

    Time to event analysis of patients with first adjudicated Stroke. The number of observed patients with adjudicated Stroke was reported.

    Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction


  7. Time to First Adjudicated SE [ Time Frame: up to 30 months ]

    Time to event analysis of patients with first adjudicated Systemic embolism (SE). The number of observed patients with adjudicated SE was reported.

    SE is an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and had to be documented by angiography, surgery, scintigraphy, or autopsy.


  8. Time to First Adjudicated ST [ Time Frame: up to 30 months ]
    Time to event analysis of patients with first adjudicated Stent Thrombosis (ST). The number of observed patients with adjudicated ST was reported.

  9. Time to Composite Endpoint of Death + MI + Stroke [ Time Frame: up to 30 months ]
    Time to event analysis of patients with the composite endpoint of death + myocardial infarction (MI) + stroke. The number of observed patients with the composite endpoint of death + myocardial infarction (MI) + stroke was reported.

  10. Time to Composite Endpoint of Death or First Thrombotic Event [ Time Frame: up to 30 months ]
    Time to event analysis of patients with composite endpoint of death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)). The number of observed patients with composite endpoint of death or thrombotic event (all death, MI, stroke/SE).

  11. Time to First Adjudicated Unplanned Revascularisation by PCI/CABG [ Time Frame: up to 30 months ]
    Time to event analysis of patients with adjudicated unplanned revascularisation by Percutaneous Coronary Intervention (PCI)/Coronary Artery Bypass Graft (CABG). The number of observed patients with adjudicated unplanned revascularisation by PCI/CABG was reported.

  12. Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG [ Time Frame: up to 30 months ]
    Time to event analysis of patients with death or thrombotic event (all death, myocardial infarction, stroke/systemic embolism) or unplanned revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft. The number of observed patients with death or first thrombotic event or unplanned revascularisation by PCI/CABG was reported.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 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)

  • 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 Creatinine Clearance (CrCl) calculated by Cockcroft-Gault equation) <30mL/min at screening
  • Active liver disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164864


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] July 21, 2016
Statistical Analysis Plan  [PDF] June 9, 2017

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02164864    
Other Study ID Numbers: 1160.186
2013-003201-26 ( EudraCT Number )
First Posted: June 17, 2014    Key Record Dates
Results First Posted: July 31, 2018
Last Update Posted: July 31, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Aspirin
Warfarin
Dabigatran
Clopidogrel
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents