| April 15, 2008 |
| June 19, 2009 |
| September 2008 |
| September 2011 (final data collection date for primary outcome measure) |
| Composite of death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding. [ Time Frame: 9 months after randomization ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00661206 on ClinicalTrials.gov Archive Site |
| The individual components of the primary endpoint [ Time Frame: 9 months after randomization ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting |
| Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of 6 vs. 12 Months Clopidogrel Therapy After Implantation of a Drug-Eluting Stent |
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. |
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. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Coronary Artery Disease |
- Drug: Clopidogrel
- Drug: Placebo
|
| |
| |
| |
| Recruiting |
| 6000 |
| December 2011 |
| September 2011 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years and older |
| No |
|
|
| Belgium, Germany, Ireland, Italy, Netherlands |
| |
| NCT00661206 |
| Prof. A. Schömig, Deutsches Herzzentrum Muenchen |
| GE IDE No. A01207 |
| Deutsches Herzzentrum Muenchen |
|
| Study Chair: |
Adnan Kastrati, MD |
Deutsches Herzzentrum Muenchen |
|
| Principal Investigator: |
Julinda Mehilli, MD |
Deutsches Herzzentrum Muenchen |
|
| Principal Investigator: |
Jurriёn M ten Berg, MD |
Department of Cardiology; St. Antonius Hospital; 3435 CM Nieuwegein; The Netherlands |
|
|
| Deutsches Herzzentrum Muenchen |
| June 2009 |
