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)

Bristol-Myers Squibb1 site in 1 country103 target enrollmentOctober 2007

ConditionsAntiplatelet Aggregation

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Antiplatelet Aggregation
Sponsor: Bristol-Myers Squibb
Enrollment: 103
Locations: 1
Primary Endpoint: Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

June 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

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

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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