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Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis

Primary Purpose

Carotid Stenosis

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Fasudil Hydrochloride

Placebo Oral Tablet

About this trial

This is an interventional other trial for Carotid Stenosis focused on measuring Patients scheduled for elective carotid endarterectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug: Fasudil hydrochloride

Drug: Placebo oral tablet

Arm Description

Fasudil hydrochloride 40 mg three times a day X 14 days

Placebo 1 tablet three times daily x 14 days

Outcomes

Primary Outcome Measures

Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00670202

First Posted

April 29, 2008

Last Updated

February 10, 2017

Sponsor

Brigham and Women's Hospital

Collaborators

Doris Duke Charitable Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00670202

Brief Title

Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis

Official Title

The Effect of Fasudil on Rho Kinase Activity in Patients Scheduled for Elective Carotid Endarterectomy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Terminated

Why Stopped

Slow enrollment

Study Start Date

March 13, 2008 (Actual)

Primary Completion Date

January 20, 2011 (Actual)

Study Completion Date

January 20, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

Collaborators

Doris Duke Charitable Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carotid Stenosis

Keywords

Patients scheduled for elective carotid endarterectomy

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Randomized, placebo controlled, parallel arm design

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Drug: Fasudil hydrochloride

Arm Type

Experimental

Arm Description

Fasudil hydrochloride 40 mg three times a day X 14 days

Arm Title

Drug: Placebo oral tablet

Arm Type

Placebo Comparator

Arm Description

Placebo 1 tablet three times daily x 14 days

Intervention Type

Drug

Intervention Name(s)

Fasudil Hydrochloride

Other Intervention Name(s)

Fasudil

Intervention Description

Fasudil 40 mg three times a day x 14 days

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Tablet

Other Intervention Name(s)

Placebo

Intervention Description

Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days

Primary Outcome Measure Information:

Title

Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens.

Description

Time Frame

>= 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anju Nohria, MD

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis

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