NCT00661206

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

Randomized, Double-Blind, Placebo-controlled Trial of 6 vs. 12 Months Clopidogrel Therapy After Implantation of a Drug-Eluting Stent

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4,005 (actual)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Clopidogrel	Patients on clopidogrel therapy at 6 months after implantation of a drug-eluting stent will be randomized to an additional 6 month period of clopidogrel 75mg per day
DRUG	Placebo	Patients randomized in this group will receive placebo for 6 months.

Timeline

• Start date: 2008-09-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2008-04-18
• Last updated: 2014-10-09

Locations

40 sites across 13 countries: United States, Albania, Austria, Belgium, China, Denmark, Germany, Ireland, Italy, Japan, Netherlands, New Zealand, Switzerland