Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting (ISAR-SAFE)
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| ClinicalTrials.gov Identifier: NCT00661206 |
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Recruitment Status : Unknown
Verified October 2014 by Deutsches Herzzentrum Muenchen.
Recruitment status was: Active, not recruiting
First Posted : April 18, 2008
Last Update Posted : October 9, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Coronary Artery Disease | Drug: Clopidogrel Drug: Placebo | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 4005 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized, Double-Blind, Placebo-controlled Trial of 6 vs. 12 Months Clopidogrel Therapy After Implantation of a Drug-Eluting Stent |
| Study Start Date : | September 2008 |
| Estimated Primary Completion Date : | November 2014 |
| Estimated Study Completion Date : | November 2014 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Clopidogrel |
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
Other Names:
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| Placebo Comparator: Placebo |
Drug: Placebo
Patients randomized in this group will receive placebo for 6 months. |
- Composite of death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding. [ Time Frame: 9 months after randomization ]
- The individual components of the primary endpoint [ Time Frame: 9 months after randomization ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00661206
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| Study Chair: | Adnan Kastrati, MD | Deutsches Herzzentrum Muenchen | |
| Principal Investigator: | Adnan Kastrati, MD | Deutsches Herzzentrum Muenchen | |
| Principal Investigator: | Jurriёn M ten Berg, MD | St. Antonius Hospital Nieuwegein, Department of Cardiology |
| Responsible Party: | Deutsches Herzzentrum Muenchen |
| ClinicalTrials.gov Identifier: | NCT00661206 |
| Other Study ID Numbers: |
GE IDE No. A01207 |
| First Posted: | April 18, 2008 Key Record Dates |
| Last Update Posted: | October 9, 2014 |
| Last Verified: | October 2014 |
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Clopidogrel Drug-eluting stent |
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Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Clopidogrel |
Platelet Aggregation Inhibitors Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |