- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00115830
Rho Kinase in Patients With Atherosclerosis
Rho Kinase in Patients With Atherosclerosis: Effects of Statins - A Double Blind, Randomized Clinical Trial Comparing Rosuvastatin and Atorvastatin
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Womens Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrew Selwyn, MD, Brigham and Womens Hospital
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Atherosclerosis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
- Rosuvastatin Calcium
Other Study ID Numbers
- 2004P-002254
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atherosclerosis
-
University Hospital, CaenUnknownPeripheral Arterial Disease | Atherosclerosis Obliterans | Atherosclerosis Right Leg | Atherosclerosis Left LegFrance
-
Nantes University HospitalAbbottCompletedAtherosclerosis ObliteransFrance
-
Federal University of São PauloCompletedAtherosclerosis of ArteryBrazil
-
MedtronicActive, not recruitingAtherosclerosis of Femoral Artery | Obstructive Disease | Atherosclerosis of Popliteal ArteryFrance
-
Central Hospital, Nancy, FranceSuspended
-
Cabinet de Medecine Interne Générale Demetrio PitarchCompletedAtherosclerosis of Artery
-
Emory UniversityThe Robert W. Woodruff FoundationCompleted
-
Zhejiang Zylox Medical Device Co., Ltd.RecruitingAtherosclerosis of Femoral ArteryGermany
-
VA Office of Research and DevelopmentCompletedSaphenous Vein Graft AtherosclerosisUnited States
-
Korea UniversityMinistry of Health & Welfare, KoreaCompletedAtherosclerosis | Noninvasive Imaging of AtherosclerosisKorea, Republic of
Clinical Trials on Rosuvastatin
-
AstraZenecaCompletedDyslipidemia | Kidney DiseaseUnited States, Puerto Rico
-
Yuhan CorporationCompletedHypertension | HyperlipidemiaKorea, Republic of
-
Ottawa Hospital Research InstituteUnknownVenous ThromboembolismCanada, Norway
-
Kobe UniversityCompletedCoronary Artery Disease Progression
-
National Institute of Diabetes and Digestive and...National Institute on Alcohol Abuse and Alcoholism (NIAAA); National Cancer... and other collaboratorsRecruitingCirrhosis | Cirrhosis, Liver | Cirrhosis Due to Hepatitis B | Cirrhosis Due to Hepatitis C | Cirrhosis Early | Cirrhosis Advanced | Cirrhosis Infectious | Cirrhosis Alcoholic | Cirrhosis, Biliary | Cirrhosis Cryptogenic | Cirrhosis Due to Primary Sclerosing CholangitisUnited States
-
Gachon University Gil Medical CenterDaewoong Pharmaceutical Co. LTD.UnknownCoronary Artery DiseaseKorea, Republic of
-
Alvogen KoreaCompletedPrimary HypercholesterolemiaKorea, Republic of
-
Hanmi Pharmaceutical Company LimitedUnknownHealthyKorea, Republic of
-
Organon and CoCompleted