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Rho Kinase in Patients With Atherosclerosis

NCT ID: NCT00115830

Last Updated: 2007-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2007-02-28

Brief Summary

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The purpose of the study is to investigate the effects of atorvastatin (Lipitor) and rosuvastatin (Crestor), United States Food and Drug Administration (FDA) approved drugs commonly prescribed by doctors to lower cholesterol, on certain functions of platelets (cells that cause blood clots), white blood cells (cells that are responsible for inflammation), and blood flow regulation by arteries. This is important because we are looking at ways to more effectively prevent atherosclerosis (plaque buildup in blood vessels) and heart disease. Many studies have demonstrated that these drugs are effective at reducing inflammation and stabilizing plaques. We are interested in better understanding the effects of these medicines on inflammation (pain and swelling) and the mechanism by which they act.

Hypothesis: Atorvastatin (40mg) will reduce inflammatory markers and activity more than Rosuvastatin (10mg) in spite of equal LDL-C reduction.

Detailed Description

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A double-blind controlled trial with two arms will be conducted at Brigham and Women's Hospital (BWH). We will screen subjects with stable atherosclerosis to complete enrollment of 40 subjects in the study (see inclusion and exclusion criteria section below). A central pharmacist at BWH will randomize the patients to 40mg of atorvastatin (n=20) or 10mg of rosuvastatin (n=20) for 28 days. If the patient is already on a statin a two-week washout period will be required prior to trial initiation. Our subjects, clinicians, data collectors, outcomes assessors and statisticians will be blind with regards to the patient allocation. There are a total of 3 visits for each patient: a short screening visit, an initial visit for baseline data (90 min.) and a final visit after 28 days. Our participants will be asked to take the medication every day at the same time between 9pm and 10pm. Each visit will take place between 7am and 9am. Patients will be instructed to fast overnight for a minimum of 8hrs. They will also be advised not to make any other changes to their current medications and lifestyle for 28 days while in the study and to record in a diary any side effects, missed doses, or changes in concomitant medication.

Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Atorvastatin

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects aged 40 to 80 years
* Documented stable atherosclerosis by angiography or vascular ultrasound (more that 20% luminal narrowing), previous myocardial infarction, ischemic stroke, peripheral arterial disease or type 2 diabetes mellitus (coronary heart disease (CHD) risk equivalent - Adult Treatment Program (ATP)-III guidelines)
* LDL-cholesterol \>100mg/dL (indication to treat with statin)
* Written informed consent
* Primary care physician authorization letter to participate in the study.

Exclusion Criteria

* Inability to give consent
* Pre-menopausal women
* Current use of antibiotics, anti-inflammatory or immunosuppressant drugs
* History of LFT \>2 times the upper normal limit
* History of myopathy/myositis or CPK \> 10 times the upper normal limit
* CPK above normal limits at study onset
* Any evidence of inflammatory, infectious or neoplastic disease
* History of CABG, PCI or acute ischemic syndrome in the preceding 3 months
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Andrew Selwyn, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Womens Hospital

Locations

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Brigham and Womens Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2004P-002254

Identifier Type: -

Identifier Source: org_study_id