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

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

Study Overview

• Status: Completed
• Conditions: Antiplatelet Aggregation
• Intervention / Treatment: Procedure: Blood Collection

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Local Institution
• Germany
  • Mainz, Germany, 55101
    • Local Institution
• Netherlands
  • Nieuwegein, Netherlands, 3435 CM
    • Local Institution
  • Rotterdam, Netherlands, 3015 GD
    • Local Institution
• United Kingdom
  • Central
    • Glasgow, Central, United Kingdom, G11 6NT
      • Local Institution
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 1; Effect of Clopidogrel withdrawal on biomarkers will be assessed via blood draws	Procedure: Blood Collection; 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L)	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.	Week 1, Week 2, Week 3, Week 4 (primary timepoint)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin	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.	Week 1, Week 2, Week 3, Week 4
Adjusted Mean Percent Changes From Baseline in Hs-CRP	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.	Week 1, Week 2, Week 3, Week 4
Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up	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.	Throughout 4-week follow-up period

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Sanofi

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: June 27, 2007
• First Submitted That Met QC Criteria: June 27, 2007
• First Posted (Estimate): June 28, 2007

Study Record Updates

• Last Update Posted (Estimate): August 10, 2010
• Last Update Submitted That Met QC Criteria: August 3, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: CV149-208; Eudract number: 2007-000713-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No