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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.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00296803
First received: February 23, 2006
Last updated: January 10, 2011
Last verified: January 2011
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bristol-Myers Squibb
Investigators
Study Director: Lisa Lilienthal, M.S. Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00296803     History of Changes
Other Study ID Numbers: L_9842
Study First Received: February 23, 2006
Last Updated: January 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Sanofi:
metabolic syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Inflammation
Syndrome
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes
Clopidogrel
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014