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Trial record 35 of 296 for:    ASPIRIN AND clopidogrel AND dual

Pharmacodynamic Effects of Dabigatran in Patients on Dual Antiplatelet Therapy

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ClinicalTrials.gov Identifier: NCT01852162
Recruitment Status : Completed
First Posted : May 13, 2013
Results First Posted : March 17, 2015
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE May 8, 2013
First Posted Date  ICMJE May 13, 2013
Results First Submitted Date  ICMJE February 3, 2015
Results First Posted Date  ICMJE March 17, 2015
Last Update Posted Date March 17, 2015
Study Start Date  ICMJE February 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2015)
TRAP-induced Platelet Aggregation [ Time Frame: 1 week ]
TRAP-induced platelet aggregation measured by light transmittance aggregometry (LTA) was similar between groups
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2013)
Platelet reactivity [ Time Frame: 1 week ]
Change History Complete list of historical versions of study NCT01852162 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2015)
  • Platelet Reactivity Measured by LTA [ Time Frame: 1-week ]
    Multiple measures of platelet reactivity evaluating purinergic and non-purinergic signaling pathways were assessed by light transmittance aggregometry (LTA).
  • Platelet Reactivity Measured by Multiple Electrode Aggregometry. [ Time Frame: 1-week ]
    Multiple measures of platelet reactivity evaluating purinergic and non-purinergic signaling pathways were assessed by multiple electrode aggregometry.
  • Clot Kinetic: Thrombin Activity [ Time Frame: 1-week ]
    Parameters related to thrombin activity and velocity of thrombus generation (reaction time: R; time to maximum rate of thrombus generation: TMRTG) were evaluated by thromboelastography.
  • Clot Kinetic: Clot Stength [ Time Frame: 1-week ]
    Clot strength (maximal amplitude:MA) was assessed by thromboelastography.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2013)
Thrombin generation profiles [ Time Frame: 1-week ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacodynamic Effects of Dabigatran in Patients on Dual Antiplatelet Therapy
Official Title  ICMJE Pharmacodynamic Effects of Dabigatran in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel
Brief Summary Dual antiplatelet therapy consisting of aspirin and clopidogrel is the cornerstone of treatment for prevention of atherothrombotic events in patients with coronary artery disease (CAD) undergoing percutaneous coronary interventions (PCI). Many patients on dual antiplatelet therapy in this setting may be affected by other thromboembolic conditions, in particular atrial fibrillation, therefore having an indication to also receive oral anticoagulation for stroke prevention. Thus, a considerable percentage of patients are under "triple therapy" which consists of aspirin plus clopidogrel plus an oral anticoagulant. The ever raising population with CAD warranting triple therapy and the growing number of patients being treated with dabigatran underscores the importance of understanding the pharmacodynamic effects of this treatment regimen.
Detailed Description

Dual antiplatelet therapy consisting of aspirin and clopidogrel is the cornerstone of treatment for prevention of atherothrombotic events in patients with coronary artery disease (CAD) undergoing percutaneous coronary interventions (PCI). Many patients on dual antiplatelet therapy in this setting may be affected by other thromboembolic conditions, in particular atrial fibrillation, therefore having an indication to also receive oral anticoagulation for stroke prevention. Thus, a considerable percentage of patients are under "triple therapy" which consists of aspirin plus clopidogrel plus an oral anticoagulant. Although this combination therapy allows a reduction of atherothrombotic and thromboembolic events, patients on triple therapy are at an increased risk of bleeding complications.

Dabigatran, a synthetic, reversible direct thrombin inhibitor, has been studied as an alternative to warfarin in patients with atrial fibrillation and has been shown to be at least as efficacious with a favorable safety profile. In particular, dabigatran at a dose of 110 mg is associated with rates of stroke and systemic embolism similar to warfarin, with lower rates of major hemorrhage, while a dose of 150 mg is associated with lower thrombotic events with similar rates of bleeding events. These findings have led the Food and Drug Administration (FDA) to approve dabigatran for use in atrial fibrillation patients in December 2011 and this has also been implemented in practice guidelines to be a superior strategy to warfarin. However, the FDA only approved the 150mg formulation.

Dabigatran has high affinity and specificity for its target serine protease thrombin, and one small study shows that dabigatran produced potent inhibition of thrombin-induced platelet aggregation in vitro. However, there are no studies assessing the ex vivo pharmacodynamic effects of dabigatran in patients on dual antiplatelet therapy. The ever raising population with CAD warranting triple therapy and the growing number of patients being treated with dabigatran underscores the importance of understanding the pharmacodynamic effects of this treatment regimen.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Drug: Dabigatran
    Dabigatran 150mg
    Other Name: Pradaxa
  • Drug: Placebo
    Matching placebo tablets
Study Arms  ICMJE
  • Experimental: Dabigatran
    Dabigatran 150mg
    Intervention: Drug: Dabigatran
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   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: March 10, 2015)
35
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2013)
25
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with known CAD
  • On maintenance treatment with aspirin (81 to 325mg per day) and clopidogrel (75 mg per day) for at least for at least 4-weeks as per standard of care.
  • Age between 18 and 80 years old.

Exclusion Criteria:

  • Transient ischemic attack or ischemic stroke in the past 6 months.
  • Prior hemorrhagic stroke (irrespective of timing).
  • Known allergies to dabigatran.
  • On treatment with Coumadin derivate or have an indication to be on Coumadin treatment (atrial fibrillation, prosthetic valve, DVT/pulmonary embolism).
  • Platelet count <80x106/mL
  • Active bleeding or hemodynamic instability.
  • Creatinine clearance <30 mL/minute.
  • Baseline ALT >2.5 times the upper limit of normal.
  • Hemoglobin < 10 gm/dL
  • Pregnant females*. *Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01852162
Other Study ID Numbers  ICMJE UFJ 2011-112
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dominick Angiolillo, MD, PhD University of Florida
PRS Account University of Florida
Verification Date March 2015

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