Inflammation and Vascular Function in Atherosclerosis

NCT00760019 | Completed Phase 2 Results DMC

• 1 other identifier: 2005P-001406
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis

Keywords

vascular inflammation; endothelium-dependent flow-mediated blood vessel function

Outcome Measures

Primary Outcomes (1)

• 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.

  Upon completion of 4 weeks of salsalate and placebo treatment

Study Arms (2)

Salsalate first, then Placebo

ACTIVE COMPARATOR

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

Placebo first, then Salsalate

PLACEBO COMPARATOR

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

Interventions

salsalate DRUG

1.5 grams orally 3 times daily

Also known as: Disalcid

Salsalate first, then Placebo

placebo DRUG

matching placebo

Placebo first, then Salsalate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-smoking adult subjects with known atherosclerosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• Sullivan AE, Courvan MCS, Ada AW, Wasserman DH, Niswender KD, Shardelow EM, Wells EK, Wells QS, Freiberg MS, Beckman JA. The Role of Serum Free Fatty Acids in Endothelium-Dependent Microvascular Function. Endocrinol Diabetes Metab. 2025 Mar;8(2):e70031. doi: 10.1002/edm2.70031.

  PMID: 39888728 DERIVED

• 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.

  PMID: 24390146 DERIVED

MeSH Terms

Conditions

Atherosclerosis

Interventions

salicylsalicylic acid

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Joshua Beckman
• Organization: Brigham and Women's Hospital

jbeckman@partners.org

617-732-6186

Study Officials

• Joshua A. Beckman, M.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: August 1, 2005
• Primary Completion: October 1, 2009
• Study Completion: February 1, 2011
• Last Updated: May 16, 2017
• Results First Posted: April 6, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)