Optimal Duration of Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation - Full Text View

Sponsors and Collaborators:	Assistance Publique - Hôpitaux de Paris Fédération Française de Cardiologie
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00822536

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease Stent Thrombosis Myocardial Ischemia	Drug: Aspirin and Clopidogrel Drug: Aspirin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Optimal Duration of Dual Antiplatelet Therapy After Drug Eluting Stent (DES) Implantation

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Attack

Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Death [ Time Frame: At each visit (every 6 months) with Follow-up of 3 years ] [ Designated as safety issue: Yes ]
Non fatal myocardial infarction [ Time Frame: At each visit (every 6 months) with Follow-up of 3 years ] [ Designated as safety issue: Yes ]
Non fatal stroke [ Time Frame: At each visit (every 6 months) with Follow-up of 3 years ] [ Designated as safety issue: Yes ]
Severe bleeding [ Time Frame: At each visit (every 6 months) with Follow-up of 3 years ] [ Designated as safety issue: Yes ]
Stent thrombosis (ARC définition) [ Time Frame: At each visit (every 6 months) with Follow-up of 3 years ] [ Designated as safety issue: Yes ]
Target lesion revascularization [ Time Frame: At each visit (every 6 months) with Follow-up of 3 years ] [ Designated as safety issue: Yes ]
Moderate bleeding (ISTH definition) [ Time Frame: At each visit (every 6 months) with Follow-up of 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1966
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Bi therapy : aspirin/ clopidogrel	Drug: Aspirin and Clopidogrel Aspirin <= 325 mg/j Clopidogrel = 75 mg /j
2: Active Comparator Monotherapy: aspirin	Drug: Aspirin Aspirin : <= 325 mg/j

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822536

Contacts

Contact: Gérard HELFT, MD,PhD

+33 (0) 1 42 16 29 12

gerard.helft@psl.aphp.fr

Locations

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

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Fédération Française de Cardiologie

Investigators

Principal Investigator:

Gérard HELFT, MD,PhD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	Department of Clinical Research of developpement ( Amel OUSLIMANI )
Study ID Numbers:	P071210
Study First Received:	January 13, 2009
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00822536 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Drug-eluting stent
Clopidogrel
Stent thrombosis
Myocardial infarction

Study placed in the following topic categories:

Anti-Inflammatory Agents
Myocardial Ischemia
Fibrinolytic Agents
Arteriosclerosis
Fibrin Modulating Agents
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Myocardial Infarction
Arterial Occlusive Diseases
Heart Diseases
Cyclooxygenase Inhibitors
Vascular Diseases

Ischemia
Cardiovascular Agents
Thrombosis
Coronary Disease
Embolism and Thrombosis
Embolism
Analgesics, Non-Narcotic
Clopidogrel
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Infarction
Antirheumatic Agents
Coronary Artery Disease

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Arteriosclerosis
Fibrin Modulating Agents
Pathologic Processes
Aspirin
Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics

Arterial Occlusive Diseases
Heart Diseases
Cyclooxygenase Inhibitors
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Ischemia
Thrombosis
Pharmacologic Actions
Coronary Disease
Embolism and Thrombosis
Analgesics, Non-Narcotic
Clopidogrel
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 01, 2009