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Slow enrollment
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| Name | Class |
|---|---|
| Doris Duke Charitable Foundation | OTHER |
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To evaluate the causal relationship between Rho/Rho kinase overactivity and mechanisms of vascular dysfunction in patients with atherosclerosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: Fasudil hydrochloride | Experimental | Fasudil hydrochloride 40 mg three times a day X 14 days |
|
| Drug: Placebo oral tablet | Placebo Comparator | Placebo 1 tablet three times daily x 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasudil Hydrochloride | Drug | Fasudil 40 mg three times a day x 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | >= 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anju Nohria, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Drug: Fasudil | Fasudil 40 mg three times a day X 14 days Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Drug: Fasudil | Fasudil 40 mg three times a day X 14 days Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | >= 2 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Drug: Fasudil | Fasudil 40 mg three times a day X 14 days Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anju Nohria | Brigham and Women's Hospital | 617-525-7052 | 617 | anohria@partners.org |
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C049347 | fasudil |
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Randomized, placebo controlled, parallel arm design
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| Placebo Oral Tablet | Drug | Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| 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 |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | 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 | 0 | 0 | 0 | 0 |
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| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |