Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00661206




Registration number
NCT00661206
Ethics application status
Date submitted
15/04/2008
Date registered
18/04/2008
Date last updated
9/10/2014

Titles & IDs
Public title
Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting
Scientific title
Randomized, Double-Blind, Placebo-controlled Trial of 6 vs. 12 Months Clopidogrel Therapy After Implantation of a Drug-Eluting Stent
Secondary ID [1] 0 0
GE IDE No. A01207
Universal Trial Number (UTN)
Trial acronym
ISAR-SAFE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Clopidogrel
Treatment: Drugs - Placebo

Active comparator: Clopidogrel -

Placebo comparator: Placebo -


Treatment: Drugs: 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

Treatment: Drugs: Placebo
Patients randomized in this group will receive placebo for 6 months.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding.
Timepoint [1] 0 0
9 months after randomization
Secondary outcome [1] 0 0
The individual components of the primary endpoint
Timepoint [1] 0 0
9 months after randomization

Eligibility
Key inclusion criteria
* Patients on clopidogrel therapy at 6 months (-1/+2 months) after DES implantation
* Informed, written consent by the patient
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2014
Actual
Sample size
Target
Accrual to date
Final
4005
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
Albania
State/province [2] 0 0
Tirana
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
China
State/province [5] 0 0
Shenyang
Country [6] 0 0
Denmark
State/province [6] 0 0
Aarhus
Country [7] 0 0
Germany
State/province [7] 0 0
Bad Krozingen
Country [8] 0 0
Germany
State/province [8] 0 0
Bad Segeberg
Country [9] 0 0
Germany
State/province [9] 0 0
Berlin
Country [10] 0 0
Germany
State/province [10] 0 0
Dresden
Country [11] 0 0
Germany
State/province [11] 0 0
Erlangen
Country [12] 0 0
Germany
State/province [12] 0 0
Garmisch-Partenkirchen
Country [13] 0 0
Germany
State/province [13] 0 0
Göttingen
Country [14] 0 0
Germany
State/province [14] 0 0
Ingolstadt
Country [15] 0 0
Germany
State/province [15] 0 0
Lahr
Country [16] 0 0
Germany
State/province [16] 0 0
Landshut
Country [17] 0 0
Germany
State/province [17] 0 0
Leipzig
Country [18] 0 0
Germany
State/province [18] 0 0
Lübeck
Country [19] 0 0
Germany
State/province [19] 0 0
Munich
Country [20] 0 0
Germany
State/province [20] 0 0
München
Country [21] 0 0
Germany
State/province [21] 0 0
Neuss
Country [22] 0 0
Germany
State/province [22] 0 0
Regensburg
Country [23] 0 0
Germany
State/province [23] 0 0
Rostock
Country [24] 0 0
Germany
State/province [24] 0 0
Ulm
Country [25] 0 0
Germany
State/province [25] 0 0
Wuppertal
Country [26] 0 0
Ireland
State/province [26] 0 0
Galway
Country [27] 0 0
Italy
State/province [27] 0 0
Rome
Country [28] 0 0
Japan
State/province [28] 0 0
Isehara
Country [29] 0 0
Japan
State/province [29] 0 0
Kyoto
Country [30] 0 0
Netherlands
State/province [30] 0 0
Eindhoven
Country [31] 0 0
Netherlands
State/province [31] 0 0
Nieuwegein
Country [32] 0 0
Netherlands
State/province [32] 0 0
Rotterdam
Country [33] 0 0
Netherlands
State/province [33] 0 0
Zwolle
Country [34] 0 0
New Zealand
State/province [34] 0 0
Auckland
Country [35] 0 0
Switzerland
State/province [35] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Other
Name
Deutsches Herzzentrum Muenchen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Adnan Kastrati, MD
Address 0 0
Deutsches Herzzentrum Muenchen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00661206