Carotid StenosisPhase 2NCT00670202

Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis

A Phase 2 study testing Fasudil Hydrochloride in people with Carotid Stenosis, run by Brigham and Women's Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Carotid Stenosis
What is being tested?: Fasudil Hydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2 participants
Where: 1 siteUnited States
Study dates: 13 Mar 2008to 20 Jan 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Brigham and Women's Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

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

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

Conditions: Carotid Stenosis
Being tested: Fasudil Hydrochloride, Placebo Oral Tablet
Keywords: Patients scheduled for elective carotid endarterectomy
Medical subject headings: Carotid Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fasudil HydrochlorideDrug
Also called Fasudil
Fasudil 40 mg three times a day x 14 days
Placebo Oral TabletDrug
Also called Placebo
Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days

Study groups in NCT00670202
Study group	Role	What they receive
Drug: Fasudil hydrochloride	Experimental	Fasudil hydrochloride 40 mg three times a day X 14 days Receives: Drug: Fasudil Hydrochloride
Drug: Placebo oral tablet	Placebo comparator	Placebo 1 tablet three times daily x 14 days Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: >= 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 200820 Jan 2011

First posted1 May 2008 (estimated)
Study start13 Mar 2008
Primary completion20 Jan 2011
Study completion20 Jan 2011

Why it stopped: Slow enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Carotid StenosisStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, placebo controlled, parallel arm design
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00670202
Sponsor's protocol ID: P-002369
Status last verified: Feb 2017
First submitted: 29 Apr 2008
Last updated: 29 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
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A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
Carotid Artery Stenosis
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Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

All Carotid Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Fasudil on Rho Kinase Activity in Patients Scheduled for Elective Carotid Endarterectomy
ClinicalTrials.gov ID: NCT00670202
Acronym / sponsor ID: P-002369
Conditions: Carotid Stenosis
Keywords: Patients scheduled for elective carotid endarterectomy
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow enrollment
Enrolment: 2 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Collaborators: Doris Duke Charitable Foundation
Study start: 13 Mar 2008 (actual)
Primary completion: 20 Jan 2011 (actual)
Study completion: 20 Jan 2011 (actual)
First posted: 1 May 2008 (estimated)
Results: Posted 29 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized, placebo controlled, parallel arm design

Arm	Type	Receives
Drug: Fasudil hydrochloride	Experimental	Drug: Fasudil HydrochlorideFasudil hydrochloride 40 mg three times a day X 14 days
Drug: Placebo oral tablet	Placebo comparator	Drug: Placebo Oral TabletPlacebo 1 tablet three times daily x 14 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

Surgery scheduled < 14 days after randomization
Pregnancy
ALT, GGT > 3x upper limit of normal (ULN)
Creatinine > 3.5 mg/dL
Prior intolerance to statins

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fasudil HydrochlorideAlso: FasudilFasudil 40 mg three times a day x 14 days	Drug	Drug: Fasudil hydrochloride
Placebo Oral TabletAlso: PlaceboPlacebo oral tablet manufactured to mimic fasudil three times a day x 14 days	Drug	Drug: Placebo oral tablet

Primary outcome

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.

Results and safety

Results posted to the registry on 29 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Drug: Fasudil	2	2
Drug: Placebo	0	0

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

Time frame: >= 2 weeks

Measure	Drug: Fasudil Hydrochloride n = 0	Drug: Placebo Oral Tablet n = 0
Value	0	0

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Drug: Fasudil	0 of 2 (0%)	0 of 2 (0%)	Not reported
Drug: Placebo	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Carotid Stenosis

Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruitingObservational study
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
Carotid Artery Stenosis
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anju Nohria, MD principal investigator

Brigham and Women's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fasudil Hydrochloride in people with Carotid Stenosis, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens. (time frame: >= 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00670202.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.