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

Coronary Artery Disease Clinical Trial

— OPTIDUAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822536
• Other study ID #: P071210
• Status: Completed
• Phase: Phase 4
• First received: January 13, 2009
• Last updated: October 16, 2014
• Start date: January 2009
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1798
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Stent Thrombosis
• Thrombosis

Intervention

Drug:
• Aspirin and Clopidogrel
Aspirin <= 325 mg/j Clopidogrel = 75 mg /j
• Aspirin
Aspirin : <= 325 mg/j

Locations

Country	Name	City	State
France	Hopital la Pitié Salpêtrière Institut de Cardiologie	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Fédération Française de Cardiologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite criteria : death, non fatal myocardial infarction, non fatal stroke and severe bleeding		At each visit (every 6 months) with Follow-up of 3 years	Yes
Secondary	Death		At each visit (every 6 months) with Follow-up of 3 years	Yes
Secondary	Non fatal myocardial infarction		At each visit (every 6 months) with Follow-up of 3 years	Yes
Secondary	Non fatal stroke		At each visit (every 6 months) with Follow-up of 3 years	Yes
Secondary	Severe bleeding		At each visit (every 6 months) with Follow-up of 3 years	Yes
Secondary	Stent thrombosis (ARC définition)		At each visit (every 6 months) with Follow-up of 3 years	Yes
Secondary	Target lesion revascularization		At each visit (every 6 months) with Follow-up of 3 years	Yes
Secondary	Moderate bleeding (ISTH definition)		At each visit (every 6 months) with Follow-up of 3 years	Yes