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

October 16, 2014 updated by: Assistance Publique - Hôpitaux de Paris

Optimal Duration of Dual Antiplatelet Therapy After Drug Eluting Stent (DES) Implantation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

1798

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Hopital la Pitié Salpêtrière Institut de Cardiologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Bi therapy : aspirin/ clopidogrel
Drug: Aspirin and Clopidogrel
Aspirin <= 325 mg/j Clopidogrel = 75 mg /j
Other Names:
  • Aspirin: acid acetylsalycilic
  • Clopidogrel: plavix
Active Comparator: 2
Monotherapy: aspirin
Drug: Aspirin
Aspirin : <= 325 mg/j
Other Names:
  • Aspirin: acid acetylsalycilic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At each visit (every 6 months) with Follow-up of 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: At each visit (every 6 months) with Follow-up of 3 years
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
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
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
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
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
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
At each visit (every 6 months) with Follow-up of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Fédération Française de Cardiologie

Investigators

  • Principal Investigator: Gérard HELFT, MD,PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (Estimate)

January 14, 2009

Study Record Updates

Last Update Posted (Estimate)

October 17, 2014

Last Update Submitted That Met QC Criteria

October 16, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P071210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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