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PROCLAIM: Study Examining Effects of Clopidogrel Compared to Placebo on Inflammation in Subjects With Metabolic Syndrome
This study has been completed.
First Received: February 23, 2006   Last Updated: January 18, 2008   History of Changes
Sponsor: Sanofi-Aventis
Collaborator: Bristol-Myers Squibb
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00296803
  Purpose

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.


Condition Intervention Phase
Metabolic Syndrome X
Drug: clopidogrel
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title: PROCLAIM: Pilot Study Examining Effects of Clopidogrel Compared to Placebo on Markers of Inflammation in Subjects With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 216
Study Start Date: November 2005
Study Completion Date: August 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296803

Locations
United States, New Jersey
Sanofi-aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi-Aventis
Bristol-Myers Squibb
Investigators
Study Director: Lisa Lilienthal, M.S. Sanofi-Aventis
  More Information

Additional Information:
No publications provided

Study ID Numbers: L 9842
Study First Received: February 23, 2006
Last Updated: January 18, 2008
ClinicalTrials.gov Identifier: NCT00296803     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Sanofi-Aventis:
metabolic syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Disease
Metabolic Diseases
Hematologic Agents
Pharmacologic Actions
Inflammation
Hyperinsulinism
Pathologic Processes
Syndrome
Clopidogrel
Therapeutic Uses
Platelet Aggregation Inhibitors
Insulin Resistance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010