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Inflammation and Vascular Function in Atherosclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Brigham and Women's Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00760019
First received: September 24, 2008
Last updated: July 22, 2010
Last verified: July 2010
History of Changes
  Purpose

The purpose of this study is to determine whether reducing inflammation in blood vessels with an aspirin-like drug called salsalate will improve blood vessel function.


Condition Intervention Phase
Atherosclerosis
 Drug: salsalate
Drug: placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inflammation and Vascular Function in Atherosclerosis

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change in flow-mediated, endothelium-dependent vasodilation [ Time Frame: following 4 weeks of salsalate/placebo ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2005
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
salsalate
 Drug: salsalate
1.5 grams orally 3 times daily
Other Name: Disalcid
Placebo Comparator: 2
placebo
 Drug: placebo
matching placebo

Detailed Description:

To test the hypothesis that inhibition of I [kappa] B kinase [beta] (IĸKβ), an inflammatory mediator, by high dose salsalate, will restore insulin-mediated endothelium-dependent vasodilation in subjects with atherosclerosis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non-smoking adult subjects with known atherosclerosis

Exclusion Criteria:

  • Uncontrolled hypertension (> 140/90 mmHg)
  • Untreated hypercholesterolemia (LDL > 160 mg/dL)
  • Diabetes mellitus
  • ALT > 150
  • Creatinine > 1.4 mg/dL
  • Concommitant use of warfarin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760019

Contacts
Contact: Whitney Redline, BA 617 732-6320 wredline@partners.org
Contact: Anju Nohria, M.D. 617 525-6852 anohria@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Whitney Redline, BA     617-732-6320     wredline@partners.org    
Contact: Anju Nohria, M.S.     617 525-6852     anohria@partners.org    
Principal Investigator: Joshua A. Beckman, M.D.            
Sub-Investigator: Anju Nohria, M.D.            
Sub-Investigator: Todd S. Perlstein, M.D.            
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Joshua A. Beckman, M.D. Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Joshua Beckman, M.D., Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00760019     History of Changes
Other Study ID Numbers: 2005P-001406
Study First Received: September 24, 2008
Last Updated: July 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
vascular inflammation
endothelium-dependent flow-mediated blood vessel function

Additional relevant MeSH terms:
Atherosclerosis
Inflammation
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Sodium Salicylate
Salicylsalicylic acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013