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

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

This study is currently recruiting participants.

Study NCT00661206. Last updated on November 3, 2008. Information provided by Deutsches Herzzentrum Muenchen

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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

Brief 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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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 ]

Secondary Outcome Measure ^†

The individual components of the primary endpoint [ Time Frame: 9 months after randomization ] [ Designated as safety issue: Yes ]

Condition ^†

Coronary Artery Disease

Intervention ^†

Drug: Clopidogrel
Drug: Placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

6000

Start Date ^†

September 2008

Completion Date

December 2011

Eligibility Criteria ^†

Inclusion Criteria:

Patients on clopidogrel therapy at 6 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
Enrollment in another clinical trial at the same time.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Julinda Mehilli, MD	49-89-1218 ext 4073	mehilli@dhm.mhn.de
Contact: Stefanie Schulz, MD	49-89-1218 ext 1521	schulzs@dhm.mhn.de

Location Countries ^†

Germany, Netherlands

Administrative Information Fields

NCT ID ^†

NCT00661206

Organization ID

GE IDE No. A01207

Secondary IDs ^††

Study Sponsor ^†

Deutsches Herzzentrum Muenchen

Collaborators ^††

Investigators ^†

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

Information Provided By

Deutsches Herzzentrum Muenchen

Verification Date

November 2008

First Received Date ^†

April 15, 2008

Last Updated Date

November 3, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.