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

Arm | Intervention/treatment |
---|---|
Experimental: Drug: Fasudil hydrochloride
Fasudil hydrochloride 40 mg three times a day X 14 days
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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
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Drug: Placebo Oral Tablet
Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days
Other Name: Placebo |
- 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.

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

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
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Anju Nohria, MD | Brigham and Women's Hospital |
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 |
Patients scheduled for elective carotid endarterectomy |
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 |