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PROCLAIM: Study Examining Effects of Clopidogrel Compared to Placebo on Inflammation in Subjects With Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00296803
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : January 11, 2011
Bristol-Myers Squibb
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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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome x Drug: clopidogrel Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: PROCLAIM: Pilot Study Examining Effects of Clopidogrel Compared to Placebo on Markers of Inflammation in Subjects With Metabolic Syndrome
Study Start Date : November 2005
Actual Study Completion Date : August 2006

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00296803

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United States, New Jersey
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Lisa Lilienthal, M.S. Sanofi

Layout table for additonal information Identifier: NCT00296803     History of Changes
Other Study ID Numbers: L_9842
First Posted: February 27, 2006    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011

Keywords provided by Sanofi:
metabolic syndrome

Additional relevant MeSH terms:
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Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs