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Completed

NCT Number: NCT00760019

Inflammation and Vascular Function in Atherosclerosis

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salsalate

Drug

1.5 grams orally 3 times daily

Other names: Disalcid

Placebo

Drug

matching placebo

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2011
First posted
Sep 25, 2008
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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