Clinical trial NCT00296803: PROCLAIM: Study Examining Effects of Clopidogrel Compared to Placebo on Inflammation in Subjects With Metabolic Syndrome
Official title: PROCLAIM: Pilot Study Examining Effects of Clopidogrel Compared to Placebo on Markers of Inflammation in Subjects With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metabolic Syndrome x
Keywords: metabolic syndrome
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2006-02-27
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of clopidogrel compared to placebo on markers of inflammation in subjects with metabolic syndrome who are receiving background therapy including low dose aspirin.


Eligibility criteria: Inclusion Criteria:

1. Men and women at least 18 years old
2. Women must be post-menopausal for one year, surgically sterilized, or using a medically accepted method of contraception and must agree to use an effective method of contraception throughout the study.
3. Subject must meet 3 of the 5 National Cholesterol Education Program/Adult Treatment Panel III (NCEP/ATP III) criteria for the classification of metabolic syndrome: triglycerides \>/= 150 mg/dL; blood pressure (BP): systolic blood pressure (SBP) \>/= 130 mmHg/diastolic blood pressure (DBP) \> 85 mmHg; fasting glucose \>/= 110 mg/dL; waist circumference: men - \> 101.6 cm (40 in)/women - \> 88.9 cm (35 in); high-density lipoprotein (HDL) cholesterol: men - \< 40 mg/dL/women - \< 50 mg/dL.
4. Subject has high-sensitivity C-reactive protein (hs-CRP) levels of \>/= 2.0 but \<10.0 mg/L at the Screening Visit (Week -2).
5. Current medication regimen must be stable for six (6) weeks, i.e. no initiation of new prescription medication nor change in dosage of any previously initiated medication within three months of entering this study.
6. Subject is normally active and judged to be in good health, based on medical history, routine safety laboratory tests (Screening Visit, Week -2), and a brief physical examination (Week -2).

Exclusion Criteria:

1. Intolerance or contraindication to the use of clopidogrel or aspirin.
2. Thrombocytopenia as defined by platelet count \< 100,000/mm3.
3. Current use or use within the past 3 months of oral anticoagulants, or dipyridamole or thienopyridine (ticlopidine or open-label clopidogrel) or oral glucocorticoids.
4. Daily aspirin in excess of 81 mg, or chronic use of non-steroidal anti-inflammatory agents.
5. Use of oral hormone replacement therapy or oral contraceptives including transdermal patch.
6. History of pathologic bleeding (i.e., peptic ulcer or intracranial hemorrhage).
7. History of chronic inflammatory disease or any recent medical event(s) resulting in tissue injury, infection, or inflammation.
8. Myocardial infarction, coronary artery bypass graft, or angioplasty within the 6 months prior to Screening.
9. Uncontrolled hypertension (systolic blood pressure \>/= 180 mmHg or diastolic blood pressure \>/= 100 mmHg) at Screening.
10. History or presence of cancer in the past 2 years, except for successfully resected basal cell carcinoma of the skin.
11. Recent history (within the past 12 months) for alcohol or substance abuse.
12. Currently taking another investigational study medication or has taken investigational study medication within 30 days prior to Screening Visit.
13. Any condition the Investigator believes would interfere with evaluation of the subject, or which could put the subject at undue risk.

Primary outcomes:
measure: To assess the effects of clopidogrel + aspirin vs placebo + aspirin on hs-CRP, CD40-ligand, soluble P-selectin, and other selected biomarkers in subjects with metabolic syndrome and elevated hs-CRP levels at study baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
Study officials:
affiliation: Sanofi
name: Lisa Lilienthal, M.S.
role: STUDY_DIRECTOR
References: