Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting (ISAR-SAFE)

German Heart Center Munich

Status and phase

Unknown

Phase 4

Conditions

Coronary Artery Disease

Treatments

Drug: Placebo

Drug: Clopidogrel

Study type

Interventional

Funder types

Other

Identifiers

NCT00661206

GE IDE No. A01207

Details and patient eligibility

About

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.

Full description

Drug elution from stent struts is associated with less smooth muscle cell proliferation and delayed stent strut re-endothelialization. Thus it seems conceivable that a longer duration of dual antiplatelet therapy (aspirin and clopidogrel) after DES implantation is needed. However, no studies have been done to investigate which is the optimal antiplatelet therapy duration after DES implantation. Therefore, the objective of the randomized, double-blind, placebo-controlled ISAR-SAFE study is to evaluate the safety and efficacy of a 6 month versus a 12 month duration of clopidogrel therapy after DES implantation.

Patients on clopidogrel therapy at least 6 months after DES implantation, who do not require a reintervention will be randomized to an additional 6 month period of clopidogrel or placebo. The patients will be followed-up for 9 months after randomization.

Enrollment

4,005 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.