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Inflammation and Vascular Function in Atherosclerosis

Primary Purpose

Atherosclerosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
salsalate
placebo
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring vascular inflammation, endothelium-dependent flow-mediated blood vessel function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Salsalate first, then Placebo

Placebo first, then Salsalate

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Flow-mediated, Endothelium-dependent Vasodilation
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.

Secondary Outcome Measures

Full Information

First Posted
September 24, 2008
Last Updated
April 17, 2017
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00760019
Brief Title
Inflammation and Vascular Function in Atherosclerosis
Official Title
Inflammation and Vascular Function in Atherosclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
vascular inflammation, endothelium-dependent flow-mediated blood vessel function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Salsalate first, then Placebo
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo first, then Salsalate
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
salsalate
Other Intervention Name(s)
Disalcid
Intervention Description
1.5 grams orally 3 times daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
Flow-mediated, Endothelium-dependent Vasodilation
Description
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.
Time Frame
Upon completion of 4 weeks of salsalate and placebo treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua A. Beckman, M.D.
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24390146
Citation
Nohria A, Kinlay S, Buck JS, Redline W, Copeland-Halperin R, Kim S, Beckman JA. The effect of salsalate therapy on endothelial function in a broad range of subjects. J Am Heart Assoc. 2014 Jan 3;3(1):e000609. doi: 10.1161/JAHA.113.000609.
Results Reference
derived

Learn more about this trial

Inflammation and Vascular Function in Atherosclerosis

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