Clinical trial NCT00493779: A Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent Implantation in Non-diabetic Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Antiplatelet Aggregation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2007-06-28
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L)
timeFrame: Week 1, Week 2, Week 3, Week 4 (primary timepoint)
Secondary outcomes:
measure: Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin
timeFrame: Week 1, Week 2, Week 3, Week 4
measure: Adjusted Mean Percent Changes From Baseline in Hs-CRP
timeFrame: Week 1, Week 2, Week 3, Week 4
measure: Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up
timeFrame: Throughout 4-week follow-up period
Other outcomes:
Locations:
city: Paris
country: France
facility: Local Institution
city: Mainz
country: Germany
facility: Local Institution
city: Nieuwegein
country: Netherlands
facility: Local Institution
city: Rotterdam
country: Netherlands
facility: Local Institution
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Central
city: Southampton
country: United Kingdom
facility: Local Institution
state: Hampshire
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1007/s11239-009-0354-y.