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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

Tracking Information
First Submitted Date  ICMJE June 13, 2014
First Posted Date  ICMJE June 17, 2014
Results First Submitted Date  ICMJE June 5, 2018
Results First Posted Date  ICMJE July 31, 2018
Last Update Posted Date July 31, 2018
Actual Study Start Date  ICMJE July 22, 2014
Actual Primary Completion Date June 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2018)
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'.
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2014)
  • Time to death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)) [ Time Frame: up to 30 months ]
  • Time to first International Society of Thrombosis and Haemostasis Major Bleeding Event [ Time Frame: up to 30 months ]
Change History Complete list of historical versions of study NCT02164864 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2018)
  • 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.
  • 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
  • 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.
  • 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.
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2014)
  • 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 event for repeated revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft [ Time Frame: up to 30 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Percutaneous Coronary Intervention
Intervention  ICMJE
  • 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: Warfarin 5mg
    Active comparator
  • Drug: Warfarin 1mg
    Active comparator
Study Arms  ICMJE
  • Experimental: Dabigatran Etexilate 110mg
    Patient to receive Dabigatran Etexilate 110mg twice a day (BID)
    Interventions:
    • Drug: Dabigatran Etexilate 110mg
    • Drug: Clopidogrel or Ticagrelor
  • Experimental: Dabigatran Etexilate 150mg
    Patient to receive Dabigatran Etexilate 150mg twice a day (BID)
    Interventions:
    • Drug: Dabigatran Etexilate 150mg
    • Drug: Clopidogrel or Ticagrelor
  • Active Comparator: Warfarin
    Warfarin doses to maintain INR
    Interventions:
    • Drug: Warfarin 3mg
    • Drug: Aspirin
    • Drug: Clopidogrel or Ticagrelor
    • Drug: Warfarin 5mg
    • Drug: Warfarin 1mg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2017)
2725
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2014)
8520
Actual Study Completion Date  ICMJE June 5, 2017
Actual Primary Completion Date June 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Croatia,   Czechia,   Denmark,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Norway,   Poland,   Portugal,   Russian Federation,   Singapore,   Slovakia,   Slovenia,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States
Removed Location Countries Czech Republic,   El Salvador
 
Administrative Information
NCT Number  ICMJE NCT02164864
Other Study ID Numbers  ICMJE 1160.186
2013-003201-26 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP