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Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis

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ClinicalTrials.gov Identifier: NCT00670202
Recruitment Status : Terminated (Slow enrollment)
First Posted : May 1, 2008
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
Anju Nohria, Brigham and Women's Hospital

Study Description
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Brief Summary:
To evaluate the causal relationship between Rho/Rho kinase overactivity and mechanisms of vascular dysfunction in patients with atherosclerosis.

Condition or disease Intervention/treatment Phase
Carotid Stenosis Drug: Fasudil Hydrochloride Drug: Placebo Oral Tablet Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, placebo controlled, parallel arm design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: The Effect of Fasudil on Rho Kinase Activity in Patients Scheduled for Elective Carotid Endarterectomy
Actual Study Start Date : March 13, 2008
Actual Primary Completion Date : January 20, 2011
Actual Study Completion Date : January 20, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Drug: Fasudil hydrochloride
Fasudil hydrochloride 40 mg three times a day X 14 days
 Drug: Fasudil Hydrochloride
Fasudil 40 mg three times a day x 14 days
Other Name: Fasudil
Placebo Comparator: Drug: Placebo oral tablet
Placebo 1 tablet three times daily x 14 days
 Drug: Placebo Oral Tablet
Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens. [ Time Frame: >= 2 weeks ]
    We were going to compare Rho/ROCK expression and eNOS expression/activity in carotid specimens obtained from patients treated with fasudil and compare those to specimens obtained from patients treated with placebo. We anticipated that Rho/ROCK expression and activity would be decreased in spcimens obtained from fasudil treated patients compared to specimens obtained from patients treated with placebo. We also anticipated that eNOS expression and activity would be increased in specimens obtained from patients treated with fasudil compared to specimens obtained from patients treated with placebo.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with >= 70% carotid stenosis (unilateral or bilateral) who are scheduled to undergo elective carotid endarterectomy
  • Age >= 18 years
  • Agreement of the operating surgeon for patient to participate

Exclusion Criteria:

  • Surgery scheduled < 14 days after randomization
  • Pregnancy
  • ALT, GGT > 3x upper limit of normal (ULN)
  • Creatinine > 3.5 mg/dL
  • Prior intolerance to statins
  • Reluctance to add or change dosage of statin therapy during study
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670202


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Doris Duke Charitable Foundation
Investigators
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Principal Investigator: Anju Nohria, MD Brigham and Women's Hospital
More Information
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Responsible Party: Anju Nohria, Associate Physician in Internal Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00670202    
Other Study ID Numbers: P-002369
First Posted: May 1, 2008    Key Record Dates
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017
Last Verified: February 2017
Keywords provided by Anju Nohria, Brigham and Women's Hospital:
Patients scheduled for elective carotid endarterectomy
Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
 Fasudil
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Protein Kinase Inhibitors
Enzyme Inhibitors