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Inflammation and Vascular Function in Atherosclerosis

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ClinicalTrials.gov Identifier: NCT00760019
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : April 6, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Joshua A. Beckman, MD, Brigham and Women's Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Atherosclerosis Drug: salsalate Drug: placebo Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inflammation and Vascular Function in Atherosclerosis
Study Start Date : August 2005
Actual Primary Completion Date : October 2009
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Salsalate first, then Placebo
In this crossover study, this group was randomly allocated therapy with salsalate first, a 4 week washout, then 4 weeks of placebo therapy in a double-blinded fashion.
Drug: salsalate
1.5 grams orally 3 times daily
Other Name: Disalcid
Placebo Comparator: Placebo first, then Salsalate
In this crossover study, this group was randomly allocated therapy with placebo first, a 4 week washout, then 4 weeks of salsalate therapy in a double-blinded fashion.
Drug: placebo
matching placebo



Primary Outcome Measures :
  1. Flow-mediated, Endothelium-dependent Vasodilation [ Time Frame: Upon completion of 4 weeks of salsalate and placebo treatment ]
    Flow-mediated, endothelium-dependent vasodilation (percentage increase in brachial artery diameter after a 5 minute ischemic stimulus) measured at the end of placebo treatment and end of salsalate treatment were compared.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • Alanine Aminotransferase > 150
  • Creatinine > 1.4 mg/dL
  • Concommitant use of warfarin

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 ClinicalTrials.gov identifier (NCT number): 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

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
Obsolete Identifiers: NCT00762827
Other Study ID Numbers: 2005P-001406
First Posted: September 25, 2008    Key Record Dates
Results First Posted: April 6, 2017
Last Update Posted: May 16, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Joshua A. Beckman, MD, Brigham and Women's Hospital:
vascular inflammation
endothelium-dependent flow-mediated blood vessel function

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