Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting

• Status: Unknown status
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether a 6 month duration of clopidogrel therapy after DES implantation is not inferior to that of a 12 month therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deutsches Herzzentrum Muenchen
• Treatments: Clopidogrel; Ticlopidine

Criteria

Inclusion Criteria:

• Patients on clopidogrel therapy at 6 months (-1/+2 months) after DES implantation

• Informed, written consent by the patient

Exclusion Criteria:

• Age ≤18 years

• Clinically symptoms, proof of ischemia and/or presence of angiographic lesions requiring revascularization

• Previous stent thrombosis

• DES in left main coronary artery

• ST-elevation and non-ST-elevation myocardial infarction during the last 6 months

• Malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance

• Planned major surgery within the next 6 months with the need to discontinue antiplatelet therapy

• Active bleeding; bleeding diathesis; history intracranial bleeding

• Oral anticoagulation therapy with coumadin derivatives

• 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

• Prior enrollment in the same clinical trial.