Trial Outcomes & Findings for Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis (NCT NCT00670202)

NCT ID: NCT00670202

Last Updated: 2017-03-29

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: >= 2 weeks
• Results posted on: 2017-03-29

Participant Flow

Participant milestones

Measure	Drug: Fasudil Fasudil 40 mg three times a day X 14 days Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days	Drug: Placebo Placebo 1 tablet three times daily x 14 days Placebo Oral Tablet: Placebo manufactured to mimic fasudil three times a day x 14 days
Overall Study STARTED	2	0
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis

Baseline characteristics by cohort

Measure	Drug: Fasudil n=2 Participants Fasudil 40 mg three times a day X 14 days Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days	Drug: Placebo 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 n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	—	2 participants n=5 Participants

PRIMARY outcome

Timeframe: >= 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.

Outcome measures

Measure	Drug: Fasudil Hydrochloride Fasudil hydrochloride 40 mg three times a day X 14 days Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days	Drug: Placebo Oral Tablet 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
Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens.	0	0

Adverse Events

Drug: Fasudil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Drug: Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anju Nohria

Brigham and Women's Hospital

Phone: 617-525-7052

Email: anohria@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place