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Optimal Duration of Dual Antiplatelet Therapy After Drug-eluting Stent Implantation (OPTIDUAL)

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ClinicalTrials.gov Identifier: NCT00822536
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : October 17, 2014
Sponsor:
Collaborator:
Fédération Française de Cardiologie
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE January 13, 2009
First Posted Date  ICMJE January 14, 2009
Last Update Posted Date October 17, 2014
Study Start Date  ICMJE January 2009
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2009)
Composite criteria : death, non fatal myocardial infarction, non fatal stroke and severe bleeding [ Time Frame: At each visit (every 6 months) with Follow-up of 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00822536 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2009)
  • Death [ Time Frame: At each visit (every 6 months) with Follow-up of 3 years ]
  • Non fatal myocardial infarction [ Time Frame: At each visit (every 6 months) with Follow-up of 3 years ]
  • Non fatal stroke [ Time Frame: At each visit (every 6 months) with Follow-up of 3 years ]
  • Severe bleeding [ Time Frame: At each visit (every 6 months) with Follow-up of 3 years ]
  • Stent thrombosis (ARC définition) [ Time Frame: At each visit (every 6 months) with Follow-up of 3 years ]
  • Target lesion revascularization [ Time Frame: At each visit (every 6 months) with Follow-up of 3 years ]
  • Moderate bleeding (ISTH definition) [ Time Frame: At each visit (every 6 months) with Follow-up of 3 years ]
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 Optimal Duration of Dual Antiplatelet Therapy After Drug-eluting Stent Implantation
Official Title  ICMJE Optimal Duration of Dual Antiplatelet Therapy After Drug Eluting Stent (DES) Implantation
Brief Summary To compare treatment with aspirin alone versus the combined antiplatelet treatment aspirin and clopidogrel after 12 months of combined antiplatelet treatment following drug-eluting stent (DES) implantation.
Detailed Description

Drug-eluting stents (DES) substantially reduce restenosis compared with bare metal stents and represent a significant advance in percutaneous coronary interventions (PCIs). Accordingly, DES have been rapidly adopted into practice and are currently used in the majority of PCI procedures. Despite their rapid acceptance, DES are not without limitations. In particular, patients who receive DES (like those who receive conventional bare metal stents) remain at risk of a 1% to 2% incidence of stent thrombosis, which is often associated with devastating consequences like death or myocardial infarction. Understanding and eliminating mediators of stent thrombosis are thus important goals for optimizing the clinical benefits of DES. Delayed endothelial coverage after DES implantation has been demonstrated and is thought to prolong the window of vulnerability to stent thrombosis. Consequently, current recommendations for DES are: dual antiplatelet therapy for at least 12 months in patients at low risk of bleeding, especially with " off-label " use. Because of rare but severe very late stent thrombosis, the dual antiplatelet therapy is more and more prescribed in clinical practice for several years.But it has been clearly demonstrated that the combination of aspirin and clopidogrel (the thienopyridine the most used) significantly increase the rate of severe and moderate bleedings when compared to aspirin alone. This is important if we consider the possibility or the necessity to prolong the combined antiplatelet therapy after stent implantation.ProposalTo compare treatment with aspirin alone versus the combined antiplatelet treatment with aspirin and clopidogrel after 12 months of combined antiplatelet treatment after DES implantation

NB : On the decision of the sponsor, the latest patient monitoring was advanced to September 30, 2014 instead of January 2015.

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
  • Stent Thrombosis
  • Myocardial Ischemia
Intervention  ICMJE
  • Drug: Aspirin and Clopidogrel
    Aspirin <= 325 mg/j Clopidogrel = 75 mg /j
    Other Names:
    • Aspirin: acid acetylsalycilic
    • Clopidogrel: plavix
  • Drug: Aspirin
    Aspirin : <= 325 mg/j
    Other Name: Aspirin: acid acetylsalycilic
Study Arms  ICMJE
  • Active Comparator: 1
    Bi therapy : aspirin/ clopidogrel
    Intervention: Drug: Aspirin and Clopidogrel
  • Active Comparator: 2
    Monotherapy: aspirin
    Intervention: Drug: Aspirin
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: October 16, 2014)
1798
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2009)
1966
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion can be done either after stenting or 12 months later :

A: Patients admitted for DES implantation can be selected. After 12 months of bi therapy, they will be randomized

B: patients who have got a DES implantation 12 months before can be selected and randomised

Inclusion criteria:

  • Patients on aspirin and clopidogrel therapy at 12 months after DES implantation
  • Informed, written consent by the patient

Exclusion criteria:

  • DES in left main coronary artery
  • Oral anticoagulation therapy with coumadin derivatives
  • Active bleeding; bleeding diathesis; history intracranial bleeding
  • Known allergy or intolerance to the study medications: aspirin and clopidogrel
  • Pregnancy (present, suspected or planned) or positive pregnancy test (In women with childbearing potential a negative pregnancy test is mandatory)
  • Patient's inability to fully comply with the study protocol
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 France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00822536
Other Study ID Numbers  ICMJE P071210
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Fédération Française de Cardiologie
Investigators  ICMJE
Principal Investigator: Gérard HELFT, MD,PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date October 2014

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