An Exploratory, Multi-center, Open-Label, Single-Arm study to evaluate theDiscontinuation Effect of Clopidogrel After Drug Eluting Stent (DECADES) onInflammatory and Platelet Activation Markers in Subjects Who Are Receiving Low Dose Acetylsalicylic Acid (ASA).Revised Protocol 02 to incorporate protocol amendments 01 and 02 - DECADES

• Conditions: Biomarkers of inflammation and platelet activation; MedDRA version: 9.1Level: LLTClassification code 10058542Term: Anti-platelet antibody

• Registration Number: EUCTR2007-000713-11-DE
• Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-26
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

1) Subjects who signed the informed consent prior to any study-related procedures.
2) 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.
3) Subjects receiving low dose ASA.
4) Subjects receiving a statin.
5) 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.
6) Subjects with no clinical history of diabetes mellitus.
7) Men and women, ages 18 years or older.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Subjects with a clinical history of diabetes mellitus.
2) History of alcohol or substance abuse within the past 12 months.
3) Any condition the Investigator believes would interfere with evaluation of the
subject or which could put the subject at undue risk.
4) Uncontrolled hypertension (systolic blood pressure >180mmHg or diastolic
>100mmHg) at screening.
5) Intolerance or contraindication to ASA or statins.
6) Current use or use within the past 3 months of oral anticoagulants or dipyridamole
or oral glucocorticoids.
7) Currently taking another investigational study medication or has taken investigational study medication within 30 days prior to screening visit .
8) Subjects who would be likely to require prohibited concomitant therapy during
the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified