Expired Study
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Jacksonville, Florida 32209


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

GE IDE No. A01207


NCT ID:

NCT00661206


Secondary ID:


Study Acronym:

ISAR-SAFE


Brief Title:

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


Official Title:

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


Overall Status:

Active, not recruiting


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Deutsches Herzzentrum Muenchen


Oversight Authority:

Germany: Federal Institute for Drugs and Medical Devices


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

4005


Enrollment Type:

Actual


Overall Contact Information

Official Name:Adnan Kastrati, MD
Study Chair
Deutsches Herzzentrum Muenchen

Study Dates

Start Date:September 2008
Completion Date:November 2014
Completion Type:Anticipated
Primary Completion Date:November 2014
Primary Completion Type:Anticipated
Verification Date:October 2014
Last Changed Date:October 8, 2014
First Received Date:April 15, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:The individual components of the primary endpoint
Time Frame:9 months after randomization
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Composite of death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding.
Time Frame:9 months after randomization
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Clopidogrel
Description: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
Arm Name:Clopidogrel
Other Name:Plavix
Intervention Type:Drug
Name:Placebo
Description:Patients randomized in this group will receive placebo for 6 months.
Arm Name:Placebo

Study Arms

Study Arm Type:Active Comparator
Arm Name:Clopidogrel
Study Arm Type:Placebo Comparator
Arm Name:Placebo

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Deutsches Herzzentrum Muenchen

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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