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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
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.
Trial website
https://clinicaltrials.gov/study/NCT00661206
Trial related presentations / publications
Schulz-Schupke S, Byrne RA, Ten Berg JM, Neumann FJ, Han Y, Adriaenssens T, Tolg R, Seyfarth M, Maeng M, Zrenner B, Jacobshagen C, Mudra H, von Hodenberg E, Wohrle J, Angiolillo DJ, von Merzljak B, Rifatov N, Kufner S, Morath T, Feuchtenberger A, Ibrahim T, Janssen PW, Valina C, Li Y, Desmet W, Abdel-Wahab M, Tiroch K, Hengstenberg C, Bernlochner I, Fischer M, Schunkert H, Laugwitz KL, Schomig A, Mehilli J, Kastrati A; Intracoronary Stenting and Antithrombotic Regimen: Safety And EFficacy of 6 Months Dual Antiplatelet Therapy After Drug-Eluting Stenting (ISAR-SAFE) Trial Investigators. ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting. Eur Heart J. 2015 May 21;36(20):1252-63. doi: 10.1093/eurheartj/ehu523. Epub 2015 Jan 23.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00661206