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

This study has been completed.
Sponsor:
Collaborator:
Fédération Française de Cardiologie
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00822536
First received: January 13, 2009
Last updated: October 16, 2014
Last verified: October 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimal Duration of Dual Antiplatelet Therapy After Drug Eluting Stent (DES) Implantation

Resource links provided by NLM:


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 ]

Enrollment: 1798
Study Start Date: January 2009
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Aspirin: acid acetylsalycilic

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00822536     History of Changes
Other Study ID Numbers: P071210
Study First Received: January 13, 2009
Last Updated: October 16, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Drug-eluting stent
Clopidogrel
Stent thrombosis
Myocardial infarction

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Thrombosis
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Embolism and Thrombosis
Heart Diseases
Vascular Diseases
Aspirin
Clopidogrel
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014