Inflammation and Vascular Function in Atherosclerosis

Mass General Brigham

Status and phase: Completed; Phase 3; Phase 2

Conditions: Atherosclerosis

Treatments: Drug: placebo; Drug: salsalate

Study type: Interventional

Funder types: Other

Identifiers

NCT00760019

2005P-001406

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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58 participants in 2 patient groups, including a placebo group

Salsalate first, then Placebo

Active Comparator group

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.

Treatment:

Drug: salsalate

Placebo first, then Salsalate

Placebo Comparator group

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.

Treatment:

Drug: placebo