Inflammation and Vascular Function in Atherosclerosis - Full Text View

Sponsored by:	Brigham and Women's Hospital
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00760019

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 II Phase III

Drug Information available for: Salicylsalicylic acid Sodium salicylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Inflammation and Vascular Function in Atherosclerosis

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:	September 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator salsalate	Drug: salsalate 1.5 grams orally 3 times daily
2: Placebo Comparator 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: Robert Copeland-Halperin, BA	617 732-6320	rcopeland-halperin@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: Robert Copeland-Halperin, BA 617-732-6320 rcopeland-halperin@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

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

Keywords provided by Brigham and Women's Hospital:

vascular inflammation
endothelium-dependent flow-mediated blood vessel function

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Salicylsalicylic acid
Sodium Salicylate

Vascular Diseases
Arteriosclerosis
Inflammation

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Physiological Effects of Drugs
Pharmacologic Actions
Pathologic Processes
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses

Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009