Clinical trial NCT00822536: Optimal Duration of Dual Antiplatelet Therapy After Drug-eluting Stent Implantation
Official title: Optimal Duration of Dual Antiplatelet Therapy After Drug Eluting Stent (DES) Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Stent Thrombosis
Myocardial Ischemia
Keywords: Drug-eluting stent
Clopidogrel
Stent thrombosis
Myocardial infarction
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Fédération Française de Cardiologie
First posted: 2009-01-14
Enrollment: 1798
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite criteria : death, non fatal myocardial infarction, non fatal stroke and severe bleeding
timeFrame: At each visit (every 6 months) with Follow-up of 3 years
Secondary outcomes:
measure: Death
timeFrame: At each visit (every 6 months) with Follow-up of 3 years
measure: Non fatal myocardial infarction
timeFrame: At each visit (every 6 months) with Follow-up of 3 years
measure: Non fatal stroke
timeFrame: At each visit (every 6 months) with Follow-up of 3 years
measure: Severe bleeding
timeFrame: At each visit (every 6 months) with Follow-up of 3 years
measure: Stent thrombosis (ARC définition)
timeFrame: At each visit (every 6 months) with Follow-up of 3 years
measure: Target lesion revascularization
timeFrame: At each visit (every 6 months) with Follow-up of 3 years
measure: Moderate bleeding (ISTH definition)
timeFrame: At each visit (every 6 months) with Follow-up of 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital la Pitié Salpêtrière Institut de Cardiologie
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Gérard HELFT, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Helft G, Steg PG, Le Feuvre C, Georges JL, Carrie D, Dreyfus X, Furber A, Leclercq F, Eltchaninoff H, Falquier JF, Henry P, Cattan S, Sebagh L, Michel PL, Tuambilangana A, Hammoudi N, Boccara F, Cayla G, Douard H, Diallo A, Berman E, Komajda M, Metzger JP, Vicaut E; OPTImal DUAL Antiplatelet Therapy Trial Investigators. Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial. Eur Heart J. 2016 Jan 21;37(4):365-74. doi: 10.1093/eurheartj/ehv481. Epub 2015 Sep 12.
citation: Helft G, Le Feuvre C, Georges JL, Carrie D, Leclercq F, Eltchaninoff H, Furber A, Prunier F, Sebagh L, Cattan S, Cayla G, Vicaut E, Metzger JP. Efficacy and safety of 12 versus 48 months of dual antiplatelet therapy after implantation of a drug-eluting stent: the OPTImal DUAL antiplatelet therapy (OPTIDUAL) trial: study protocol for a randomized controlled trial. Trials. 2013 Feb 21;14:56. doi: 10.1186/1745-6215-14-56.