Inflammation and Vascular Function in Atherosclerosis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2011-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

salsalate

Intervention Type DRUG

1.5 grams orally 3 times daily

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

matching placebo

Interventions

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salsalate

1.5 grams orally 3 times daily

Intervention Type DRUG

placebo

matching placebo

Intervention Type DRUG

Other Intervention Names

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Disalcid

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes