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)
- Conditions
- subjects with one or more drug eluting stents1001108210047066
- Registration Number
- NL-OMON31060
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
1. Subjects with one or more sirolimus or paclitaxel drug-eluting stents who are coming to the end of their 12 months of clopidogrel (75 mg daily) treatment.
2. Subjects receiving low dose ASA.
3. Subjects receiving a statin.
4. 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.
5. Subjects with no clinical history of diabetes mellitus.
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Assess the mean change in the level of soluble CD40 Ligand over a four week<br /><br>follow up period following withdrawal of clopidogrel after a 12 month treatment<br /><br>period.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Changes in levels of high sensitivity C-reactive protein (hs-CRP) and plasma<br /><br>soluble P-selectin.<br /><br>2. Safety (evaluated by Adverse Event/Serious Adverse Event (AE/SAE) reports).</p><br>