Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Condition Carotid Stenosis
Interventions Drug: Fasudil Hydrochloride
Drug: Placebo Oral Tablet
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Drug: Fasudil Drug: Placebo
Hide Arm/Group Description

Fasudil 40 mg three times a day X 14 days

Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days

Placebo 1 tablet three times daily x 14 days

Placebo Oral Tablet: Placebo manufactured to mimic fasudil three times a day x 14 days

Period Title: Overall Study
Started 2 [1] 0
Completed 2 [1] 0
Not Completed 0 0
[1]
Investigators blinded to study drug assignment due to early termination of study
Arm/Group Title Drug: Fasudil Drug: Placebo Total
Hide Arm/Group Description

Fasudil 40 mg three times a day X 14 days

Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days

Placebo 1 tablet three times daily x 14 days

Placebo Oral Tablet: Placebo manufactured to mimic fasudil three times a day x 14 days

Total of all reporting groups
Overall Number of Baseline Participants 2 0 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 0 participants 2 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
>=65 years
2
 100.0%
2
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 0 participants 2 participants
Female
2
 100.0%
2
 100.0%
Male
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 0 participants 2 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
White
2
 100.0%
2
 100.0%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 0 participants 2 participants
2 2
1.Primary Outcome
Title Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens.
Hide Description 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.
Time Frame >= 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drug: Fasudil Hydrochloride Drug: Placebo Oral Tablet
Hide Arm/Group Description:

Fasudil hydrochloride 40 mg three times a day X 14 days

Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days

Placebo 1 tablet three times daily x 14 days

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Drug: Fasudil Drug: Placebo
Hide Arm/Group Description

Fasudil 40 mg three times a day X 14 days

Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days

Placebo 1 tablet three times daily x 14 days

Placebo Oral Tablet: Placebo manufactured to mimic fasudil three times a day x 14 days

All-Cause Mortality
Drug: Fasudil Drug: Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Drug: Fasudil Drug: Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Drug: Fasudil Drug: Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/0 
Study was terminated early due to poor enrollment. The patients and physicians remained blinded to study drug assignment for the 2 patients who completed the protocol and no analyses were performed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anju Nohria
Organization: Brigham and Women's Hospital
Phone: 617-525-7052 ext 617
EMail: anohria@partners.org
Layout table for additonal information
Responsible Party: Anju Nohria, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00670202    
Other Study ID Numbers: P-002369
First Submitted: April 29, 2008
First Posted: May 1, 2008
Results First Submitted: February 10, 2017
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017