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| Name | Class |
|---|---|
| Fédération Française de Cardiologie | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Bi therapy : aspirin/ clopidogrel |
|
| 2 | Active Comparator | Monotherapy: aspirin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin and Clopidogrel | Drug | Aspirin <= 325 mg/j Clopidogrel = 75 mg /j |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Death | At each visit (every 6 months) with Follow-up of 3 years | |
| Non fatal myocardial infarction | At each visit (every 6 months) with Follow-up of 3 years | |
| Non fatal stroke |
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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:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gérard HELFT, MD,PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital la Pitié Salpêtrière Institut de Cardiologie | Paris | 75010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26364288 | Derived | 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. | |
| 23433461 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Aspirin | Drug | Aspirin : <= 325 mg/j |
|
|
| At each visit (every 6 months) with Follow-up of 3 years |
| Severe bleeding | At each visit (every 6 months) with Follow-up of 3 years |
| Stent thrombosis (ARC définition) | At each visit (every 6 months) with Follow-up of 3 years |
| Target lesion revascularization | At each visit (every 6 months) with Follow-up of 3 years |
| Moderate bleeding (ISTH definition) | At each visit (every 6 months) with Follow-up of 3 years |
| Derived |
| 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. |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |