A Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent Implantation in Non-diabetic Patients (DECADES)
|ClinicalTrials.gov Identifier: NCT00493779|
Recruitment Status : Completed
First Posted : June 28, 2007
Results First Posted : August 11, 2009
Last Update Posted : August 10, 2010
|Condition or disease||Intervention/treatment||Phase|
|Antiplatelet Aggregation||Procedure: Blood Collection||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
No Intervention: 1
Effect of Clopidogrel withdrawal on biomarkers will be assessed via blood draws
Procedure: Blood Collection
- Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L) [ Time Frame: Week 1, Week 2, Week 3, Week 4 (primary timepoint) ]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.
- Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin [ Time Frame: Week 1, Week 2, Week 3, Week 4 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00493779
|Paris, France, 75013|
|Mainz, Germany, 55101|
|Nieuwegein, Netherlands, 3435 CM|
|Rotterdam, Netherlands, 3015 GD|
|Glasgow, Central, United Kingdom, G11 6NT|
|Southampton, Hampshire, United Kingdom, SO16 6YD|
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|