Biomarkers of inflammation and platelet activation MedDRA version: 9.1 Level: LLT Classification code 10058542 Term: Anti-platelet antibody
Conditions
Interventions
Pharmaceutical Form:
INN or Proposed INN: clopidogrel
Sponsors
Bristol Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who signed the informed consent prior to any study-related procedures. 2) 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. 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 50 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
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 participating in a non-sirolimus or non-paclitaxel drug-eluting stent study 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if the withdrawal of clopidogrel 12 months after DES implantation leads to an increase in the level of soluble CD40 Ligand over a four weeks follow-up period.;Secondary Objective: To assess the withdrawal of clopidogrel 12 months after DES implantation on: • Laboratory biomarkers: - Plasma soluble P-selectin - High sensitivity C-reactive protein (hs-CRP) • Safety measures: Adverse Events (AE) / Serious Adverse Events (SAE) reports.;Primary end point(s): Primary Biomarkers Blood will be drawn to assess the levels of the soluble CD40 Ligand biomarker at each visit. Secondary biomarker measurements are: • Plasma soluble P-selectin • hs-CRP Blood will be drawn at each visit. Safety Safety will be evaluated during the entire study period of a subject by reporting of adverse events (AEs) and serious adverse events (SAEs), including reporting of any bleeding and locally available laboratory tests performed because of an adverse event. | — |
Countries
France, Germany, Netherlands, United Kingdom
Outcome results
None listed