Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Triple Therapy in Patients on Oral Anticoagulation After Drug Eluting Stent Implantation (ISAR-TRIPLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00776633
Recruitment Status : Unknown
Verified August 2014 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Active, not recruiting
First Posted : October 21, 2008
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

Tracking Information
First Submitted Date  ICMJE October 20, 2008
First Posted Date  ICMJE October 21, 2008
Last Update Posted Date August 30, 2016
Study Start Date  ICMJE September 2008
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2008)
Composite of death, myocardial infarction, definite stent thrombosis, stroke or major bleeding. [ Time Frame: 9 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2008)
  • Ischemic complications (composite of cardiac death, myocardial infarction, stent thrombosis or ischemic stroke) [ Time Frame: 9 months ]
  • Bleeding complications (Major bleeding) [ Time Frame: 9 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Triple Therapy in Patients on Oral Anticoagulation After Drug Eluting Stent Implantation
Official Title  ICMJE Intracoronary Stenting and Antithrombotic Regimen: Testing of a Six-week Versus a Six-month Clopidogrel Treatment Regimen in Patients With Concomitant Aspirin and Oral Anticoagulant Therapy Following Drug-eluting Stenting
Brief Summary The investigators hypothesize that reducing the duration of clopidogrel therapy from 6 months to 6 weeks after DES implantation is associated with improved clinical outcomes in patients on ASA and an oral anticoagulant.
Detailed Description The introduction of drug-eluting stents (DES) was associated not only with a widening of the indication for percutaneous coronary intervention (PCI) but also with longer antithrombotic therapy duration. Dual antiplatelet therapy with ASA and a thienopyridine is very efficient in preventing adverse events after coronary stenting but it is inferior to oral anticoagulation (OAC) to reduce the risk of stroke in patients with atrial fibrillation. OAC is also superior to antiplatelet therapy in patients with mechanical heart valves and the therapy of choice for the treatment of deep vein thrombosis and pulmonary embolism. OAC is also administered for left ventricular thrombi and low ejection fraction. There is an increasing number of patients undergoing coronary stenting who are in need of life-long anticoagulation therapy and would therefore require a triple therapy consisting of aspirin, clopidogrel and oral anticoagulation. As oral anticoagulation and antithrombotic therapy impair primary and secondary hemostasis there are concerns that adding warfarin to dual antiplatelet therapy might cause increased bleeding rates. Several studies have retrospectively assessed efficacy and safety in patients receiving a triple therapy with various results: major bleeding rates varied from 3,1%-14,9% with total bleeding rates up to 27,5%. Prospective randomized data on this topic are not available. Therefore the aim of this study is to compare a 6 week versus a 6 month triple therapy after DES implantation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • Atrial Fibrillation
Intervention  ICMJE
  • Drug: aspirin
    6 weeks triple therapy with aspirin, clopidogrel and oral anticoagulation
  • Drug: clopidogrel
    6 months triple therapy with aspirin, clopidogrel and oral anticoagulation
  • Drug: oral anticoagulation
Study Arms  ICMJE
  • Experimental: Short triple
    6 weeks triple therapy
    Interventions:
    • Drug: aspirin
    • Drug: clopidogrel
    • Drug: oral anticoagulation
  • Active Comparator: Long triple
    6 months triple therapy
    Interventions:
    • Drug: aspirin
    • Drug: clopidogrel
    • Drug: oral anticoagulation
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 Unknown status
Actual Enrollment  ICMJE
 (submitted: August 28, 2014)
614
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2008)
600
Estimated Study Completion Date  ICMJE September 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Patients with an indication for oral anticoagulation and a DES implantation.
  2. Informed, written consent by the patient or her/his legally-authorized representative for participation in the study.

Key Exclusion Criteria:

  1. Age ≤18 years
  2. Previous stent thrombosis
  3. DES in left main
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 Denmark,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00776633
Other Study ID Numbers  ICMJE GE IDE No. A01508
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Deutsches Herzzentrum Muenchen
Study Sponsor  ICMJE Deutsches Herzzentrum Muenchen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Adnan Kastrati, MD Deutsches Herzzentum München
Principal Investigator: Stefanie Schulz, MD Deutsches Herzzentrum Muenchen
PRS Account Deutsches Herzzentrum Muenchen
Verification Date August 2014

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