Inflammation and Vascular Function in Atherosclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joshua A. Beckman, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00760019
First received: September 24, 2008
Last updated: August 14, 2013
Last verified: August 2013
  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:


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 ]

Enrollment: 44
Study Start Date: August 2005
Study Completion Date: February 2011
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

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
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 by Brigham and Women's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joshua A. Beckman, MD, MD, 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: August 14, 2013
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 April 17, 2014