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| Name | Class |
|---|---|
| Chiesi USA, Inc. | INDUSTRY |
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The aim is to compare the rate of hypertensive subjects with ICH who reach SBP target with stability within 60 minutes of enrollment, among patients treated with IV clevidipine with those treated with alternate IV antihypertensive regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| designated clevidipine hospitals |
| ||
| designated non-clevidipine hospitals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clevidipine Injection | Drug | Sites will be trained and instructed to administer IV clevidipine according to Food and Drug Administration label, which recommends starting at 1-2 mg/hour, and then doubling the dose initially at short (90 second) intervals. As the BP approaches the goal, the increase in doses should be less than doubling and the time between dose adjustments should be lengthened to every 5-10 minutes. The desired therapeutic response for most patients occurs at doses of 4-6 mg/hour. Most patients have been treated with maximum doses of 16 mg/hour or less. There is limited short-term experience with doses up to 32 mg/hour, and because of lipid load restrictions, no more than 1000 mL or an average of 21 mg/hour of Clevidipine infusion is recommended per 24-hour period. There is little experience beyond 72 hours at any dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure Monitoring | To compare the rate of hypertensive subjects with ICH who reach SBP target with stability within 60 minutes of enrollment, among patients treated with IV clevidipine with those treated with alternate IV antihypertensive regimen. SBP target with stability is defined as achieving a SBP of less than 150 mm Hg and greater than 130 mm Hg with two subsequent consecutive recordings at least 15 minutes apart that show SBP of less than 150 mm Hg and greater than 130 mm Hg. | 15 minutes |
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Inclusion Criteria
Exclusion Criteria
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All subjects 18 years or older but less than 100 years old who present to the study sites with clinical symptoms consistent with an ICH demonstrated on brain imaging are to be screened for study eligibility.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Recruiting | Irvine | California | 92696-7600 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40993486 | Derived | Qureshi AI, Baskett W, Gomes JA, Lakhani P, Rabinstein AA, Rose DZ, Suarez JI, Steiner T, Shyu CR. The Association between Hourly Systolic Blood Pressure Variability and Outcomes in Patients with Intracerebral Hemorrhage is Time-Dependent: Post-hoc Analysis of the ATACH-2 Trial. Neurocrit Care. 2026 Apr;44(2):647-655. doi: 10.1007/s12028-025-02376-0. Epub 2025 Sep 24. |
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|
| Alternate IV Antihypertensive Regimen | Drug | The alternate IV antihypertensive regimen would be the institutional standard management at designated "non-clevidipine hospitals". It is expected that most of these sites will be using IV nicardipine, which if administered per FDA label is started at 5 mg/hour and increased by 2.5 mg/hour every 5-15 minutes to a maximum dose of 15mg/hour, until desired BP is reached. Once the goal is reached, then the dose may be reduced to 3 mg/hour. |
|
| Antelope Valley Medical Center | Recruiting | Lancaster | California | 93534 | United States |
|
| Stanford Medical Center (Stanford Health Care) | Recruiting | Palo Alto | California | 94304 | United States |
|
| Cleveland Clinic Martin North Hospital | Recruiting | Stuart | Florida | 34994 | United States |
|
| University of South Florida | Recruiting | Tampa | Florida | 33606 | United States |
|
| Cleveland Clinic Florida | Recruiting | Weston | Florida | 33331 | United States |
|
| Augusta University-Neuroscience Center | Recruiting | Augusta | Georgia | 30912 | United States |
|
| University of Michigan Health-West | Recruiting | Wyoming | Michigan | 49519 | United States |
|
| CentraCare - St. Cloud Hospital | Recruiting | Saint Cloud | Minnesota | 56303 | United States |
|
| University of Missouri | Recruiting | Columbia | Missouri | 65212 | United States |
|
| Albany Medical Center | Recruiting | Albany | New York | 12208 | United States |
|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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| Cleveland Clinic Akron General | Recruiting | Akron | Ohio | 44307 | United States |
|
| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| ProMedica Toledo Hospital | Recruiting | Toledo | Ohio | 43606 | United States |
|
| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
|
| University of Texas Health Science Center San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
|
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D020521 | Stroke |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C118563 | clevidipine |
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