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A Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent Implantation in Non-diabetic Patients (DECADES)

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00493779
First received: June 27, 2007
Last updated: August 3, 2010
Last verified: June 2010

June 27, 2007
August 3, 2010
October 2007
June 2008   (final data collection date for primary outcome measure)
Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L) [ Time Frame: Week 1, Week 2, Week 3, Week 4 (primary timepoint) ] [ Designated as safety issue: No ]
Based on ANCOVA models performed on log scale controlling for site & natural logarithm of baseline soluble CD40 Ligand value. Percent changes from baseline can be interpreted as the difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change might indicate possible enhanced platelet activation.
to assess if the withdrawal of clopidogrel 12 months after DES Implantation leads to an increase in the level of soluble CD40 Ligand over a four week follow-up period [ Time Frame: at four weeks ]
Complete list of historical versions of study NCT00493779 on ClinicalTrials.gov Archive Site
  • Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin [ Time Frame: Week 1, Week 2, Week 3, Week 4 ] [ Designated as safety issue: No ]
    Based on ANCOVA models performed on log scale controlling for site and natural logarithm of baseline Plasma Soluble P-selectin value. Percent changes from baseline can be interpreted as difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change is known to be mediated by increases in sCD40L.
  • Adjusted Mean Percent Changes From Baseline in Hs-CRP [ Time Frame: Week 1, Week 2, Week 3, Week 4 ] [ Designated as safety issue: No ]
    ANCOVA models performed on log scale controlling for site & natural logarithm of baseline hs-CRP. Back-transformed mean percent changes are presented. Percent changes from baseline can be interpreted as difference of biomarker timepoint value - baseline value ÷ baseline value. Since there is no measure of platelet inhibition or overall thrombogenicity assay presented here, a negative percent change for this measure can not be judged on its own as indicating improvement.
  • Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up [ Time Frame: Throughout 4-week follow-up period ] [ Designated as safety issue: Yes ]
    An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
  • to assess the withdrawal of clopidogrel 12 months after DES implantation on laboratory biomarkers: Plasma soluble P-selection, High sensitivity C-reactive protein (hs-CRP) [ Time Frame: at four weeks ]
  • to assess the withdrawal of clopidogrel 12 months after DES implantation on Safety measures: Adverse Events (AE) Serious Adverse Events (SAE) reports [ Time Frame: at four weeks ]
Not Provided
Not Provided
 
A Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent Implantation in Non-diabetic Patients
An Exploratory, Multi-Center, Open-Label, Single-Arm Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent (DECADES) on Inflammatory and Platelet Activation Markers in Subjects Who Are Receiving Low Dose Acetylsalicylic Acid (ASA)

The purpose of the study is to look at the biomarkers of inflammation and platelet activation in patients with drug eluting stents implanted approximately 12 months ago on aspirin and statin, for a 4-week period after the routine discontinuation of clopidogrel

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Antiplatelet Aggregation
Procedure: Blood Collection
4 weeks
No Intervention: 1
Effect of Clopidogrel withdrawal on biomarkers will be assessed via blood draws
Intervention: Procedure: Blood Collection
Wykrzykowska JJ, Warnholtz A, de Jaeger P, Curzen N, Oldroyd KG, Collet JP, Ten Berg JM, Rademaker T, Goedhart D, Lissens J, Kint PP, Serruys PW. Effect of clopidogrel discontinuation at 1 year after drug eluting stent placement on soluble CD40L, P-selectin and C-reactive protein levels: DECADES (Discontinuation Effect of Clopidogrel After Drug Eluting Stent): a multicenter, open-label study. J Thromb Thrombolysis. 2009 Nov;28(4):410-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with one or more drug-eluting stents of any type who are coming to the end of their 12 months of clopidogrel (75 mg daily) treatment
  • Subjects receiving low dose ASA
  • Subjects receiving a statin
  • Current medication regimen (including ASA and statins) must have been stable for three (3) months. i.e. no initiation of new prescription medication or change in dosage of any previously initiated medication within three (3) months of entering this study
  • Subjects with no clinical history of diabetes mellitis
  • Men and women, ages 18 years or older
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Netherlands,   United Kingdom
 
NCT00493779
CV149-208, Eudract number: 2007-000713-11
Not Provided
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Sanofi
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP