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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: Antiplatelet Aggregation

Treatments: Procedure: Blood Collection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00493779

Eudract number: 2007-000713-11

CV149-208

Details and patient eligibility

About

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

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

103 participants in 1 patient group

1

No Intervention group

Description:

Effect of Clopidogrel withdrawal on biomarkers will be assessed via blood draws

Treatment:

Procedure: Blood Collection