Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01NS044976-01A2 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this trial is to evaluate the safety and effectiveness of lowering blood pressure using nicardipine in persons with acute hypertension associated with intracerebral hemorrhage.
An estimated 37,000 to 52,400 people in the United States have intracerebral hemorrhage (ICH) every year. ICH--a form of stroke that has poor outcome and is difficult to treat--is associated with the highest mortality rate of all strokes. Hematoma expansion has been identified as the most common cause of neurological deterioration in persons with ICH. Early evidence suggests that acute hypertension (HTN)-or elevated blood pressure-may make some individuals more susceptible to hematoma expansion. Treating HTN acutely may prevent hematoma expansion, however, the effect of aggressive HTN treatment has not been determined.
The purpose of this trial is to evaluate the treatment feasibility and safety of lowering blood pressure using nicardipine--an antihypertensive medication--in persons who have acute HTN associated with ICH.
This pilot study will enroll 60 individuals who qualify with a presenting systolic blood pressure of at least 170 mmHg, have an ICH, and can be evaluated and treatment initiated within 6 hours of onset of stroke symptoms. In a stepwise fashion, the scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 3 sequential levels: 170 to 200 mmHg, 140 to 170 mmHg, and 110 to 140 mmHg. Twenty participants will be enrolled per level.
Treatment will last 18 to 24 hours. Participants will stay in the hospital for about 7 days (including 24 hours in the intensive care unit for close monitoring) and will return for 1-hour follow-up visits at 30 days and at 90 days after discharge from the hospital. During these visits participants will receive neurological assessments to determine their functional outcome. For participants, the study will be completed after the 90-day follow-up visit.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tier 1 | Other | Dose escalation: The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 170 to 200 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician. |
|
| Tier 2 | Other | Dose escalation: The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 140 to 170 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician. |
|
| Tier 3 | Other | Dose escalation: The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 110 to 140 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nicardipine | Drug | Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
|
| Measure | Description | Time Frame |
|---|---|---|
| Particpants Who Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier. | Feasibility of treatment was assessed by whether SBP reduction and maintenance within the respective target range was achieved (treatment success) or not (treatment failure), and secondarily by whether a significant difference between treatment arms was achieved. Treatment failure was defined based on the observed hourly hourly minimum SBP remaining greater than the upper limit of the target range for 2 consecutive hours after initiation of nicardipine infusion. Spontaneous decline of SBP below the lower limit of the specific tier was not considered treatment failure as all such declines were asymptomatic.The lower number in the more intensive treatment groups reflects in part the greater challenge of rapidly lowering systolic blood pressure to a more intensive (lower) range, as a higher number of treatment failures as pre-defined by meeting the SBP range goal within 3 hours of symptom onset in this group predictably occurred. | Within 3 hours of symptom onset and sustained through 18-24 hours. |
| Number of Participants With Neurological Deteriorations (Decrease of 2 or More Points on the GCS Score or an Increase of 4 or More Points on the NIHSS Score) During the 24 Hour Treatment", | Neurological status was monitored quantitatively and independently of other adverse events using two scales. The Glasgow Coma Scale (GCS) score measures level of consciousness in eye, motor, and verbal components. At least one point is given in each category. The scale ranges from 3 to 15, with 3 indicating deep unconsciousness and 15 indicating consciousness is not impaired. The National Institutes of Health Stroke Scale (NIHSS) quantifies neurologic deficits in 11 categories. Level of consciousness, horizontal eye movements, visual fields, facial palsy, movement in each limb, sensation, language and speech, and extinction or inattention on one side of the body are tested. Scores range from 0 to 42; 0 indicates normal function and higher scores indicate greater deficit severity. | within the first 72 hours of treatment initiation |
| Total Number of Serious Adverse Events Within the Initial 72 Hours From Treatment Per Subject | Serious adverse events were ascertained by site investigators using FDA-defined guidelines, defined as any untoward clinical events having been fatal, life-threatening, resulting in new or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage. Subjects were followed closely from randomization through 90 days. The initial 72-hour period was chosen as the most meaningful time period for which to examine SAEs likely to be related to the acute safety of the study treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Particpants Who Tolerate Rapid Systolic Blood Pressure Reduction and Maintain Treatment Goals | The ability to maintain the Specified Systolic Blood Pressure Range for the 18-24 Hour Period without Neurological Deterioration or Side Effects | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Particpants Who Achieve Reduction of Blood Pressure and Maintain Treatment Goals (the Specified Systolic Blood Pressure Range for the 18-24 Hour Period) Without Neurological Deterioration or Side Effects Resulting in Death. | The tolerability of the study treatment was further ascertained by examination of in-hospital, 1-month, or 3-month mortality in each treatment group. This pilot study was not powered (did not plan to enroll an adequate number of patients) to draw meaningful conclusions about individual adverse event categories, outcome measures, or to make comparisons between the treatment arms beyond the overall feasibility and tolerability of rapidly and significantly lowering SBP following intracerebral hemorrhage. The timing and magnitude of SBP reduction was also compared to the timing of individual safety events to further evaluate possible relationships between the study treatment, adverse events, and any recognizable safety concerns. This information is available in publication but is not able to be displayed on this website due to formatting restrictions. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adnan I. Qureshi, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Kansas University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17356194 | Background | Qureshi AI. Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH): rationale and design. Neurocrit Care. 2007;6(1):56-66. doi: 10.1385/ncc:6:1:56. | |
| 20457956 | Result | Qureshi AI, Palesch YY, Martin R, Novitzke J, Cruz-Flores S, Ehtisham A, Ezzeddine MA, Goldstein JN, Hussein HM, Suri MF, Tariq N; Antihypertensive Treatment of Acute Cerebral Hemorrhage Study Investigators. Effect of systolic blood pressure reduction on hematoma expansion, perihematomal edema, and 3-month outcome among patients with intracerebral hemorrhage: results from the antihypertensive treatment of acute cerebral hemorrhage study. Arch Neurol. 2010 May;67(5):570-6. doi: 10.1001/archneurol.2010.61. |
Not provided
Not provided
consult investigator for options
Not provided
Not provided
Not provided
Not provided
A progressive, three-tiered approach to lowering systolic blood pressure with DSMB review after enrollment in each successive SBP range was completed. Safety was determined at each level before progressing to the next. Subjects meeting criteria and consenting to participate were considered enrolled and have been included in the data analysis.
Patients 18 years and older presenting to site hospital ED and ICU areas within 6 hours of symptom onset for ≤ 60 cc volume intracerebral hemorrhage, with GCS ≥ 8, systolic blood pressure ≥ 170 mmHg and meeting all inclusion/exclusion criteria were enrolled following consent by themselves or a family member/legally authorized representative.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tier 1 | Dose escalation: Initial range The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
The DSMB will review safety, tolerability, and feasibility before escalation to the next level. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Staged intensity levels of rapid intravenous antihypertensive control for elevated SBP in patients with intracerebral hemorrhage were implemented in 3 sequential treatment arms to assess the feasibility and tolerability (safety) of this treatment.
Not provided
Not provided
Open treatment assignment was employed because it is not safe to conceal SBP measurement. Patient data routinely entered by clinical staff were used to evaluate safety.
Not provided
|
|
| from treatment initiation through 72 hours |
| From enrollment through 3 months |
| Kansas City |
| Kansas |
| 66160 |
| United States |
| The University of Kansas School of Medicine, Wichita Via Christi Regional Medical Center | Kansas City | Kansas | 66160 | United States |
| Massachusetts General/Brigham Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Clinical Coordinating Center: University of Minnesota, Fairview Hospital | Minneapolis | Minnesota | 55455 | United States |
| Saint Louis University | St Louis | Missouri | 63108 | United States |
| JFK Medical Center | Edison | New Jersey | 08818 | United States |
| University of Medicine and Dentistry of New Jersey | Newark | New Jersey | 07107 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Statistical Coordinating Center: Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| 19770736 | Result | Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) investigators. Antihypertensive treatment of acute cerebral hemorrhage. Crit Care Med. 2010 Feb;38(2):637-48. doi: 10.1097/CCM.0b013e3181b9e1a5. |
| 18606927 | Result | Qureshi AI. Acute hypertensive response in patients with stroke: pathophysiology and management. Circulation. 2008 Jul 8;118(2):176-87. doi: 10.1161/CIRCULATIONAHA.107.723874. No abstract available. |
| 22560810 | Result | Qureshi AI, Palesch YY, Martin R, Novitzke J, Cruz Flores S, Ehtisham A, Goldstein JN, Kirmani JF, Hussein HM, Suri MF, Tariq N; Antihypertensive Treatment of Acute Cerebral Hemorrhage Investigators. Systolic blood pressure reduction and risk of acute renal injury in patients with intracerebral hemorrhage. Am J Med. 2012 Jul;125(7):718.e1-6. doi: 10.1016/j.amjmed.2011.09.031. Epub 2012 May 4. |
| 21626077 | Result | Qureshi AI, Palesch YY. Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) II: design, methods, and rationale. Neurocrit Care. 2011 Dec;15(3):559-76. doi: 10.1007/s12028-011-9538-3. |
| 23233387 | Derived | Hussein HM, Tariq NA, Palesch YY, Qureshi AI; ATACH Investigators. Reliability of hematoma volume measurement at local sites in a multicenter acute intracerebral hemorrhage clinical trial. Stroke. 2013 Jan;44(1):237-9. doi: 10.1161/STROKEAHA.112.667220. Epub 2012 Dec 11. |
| FG001 | Tier 2 | Dose escalation: The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
The DSMB will review safety, tolerability, and feasibility before escalation to the next level. |
| FG002 | Tier 3 | Dose escalation: The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Group numbers were adjusted as adequate safety parameters were met in each successive treatment tier. A larger number of subjects were therefore evaluated in the final tier where safety is of greatest concern and SBP parameter is also of greatest challenge to meet.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tier 1 | Dose escalation: The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 170 to 200 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician. nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
|
| BG001 | Tier 2 | Dose escalation: The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 140 to 170 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician. nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
|
| BG002 | Tier 3 | Dose escalation: The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 110 to 140 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician. nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
|
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Baseline Measures - Timing of Treatment | as mean time in hours from symptom onset | Mean | Standard Deviation | hours |
| ||||||||||||||
| Initial SBP | as measured on ED arrival by automated cuff inflation device | Median | Full Range | millimeters of mercury (mmHg) |
| ||||||||||||||
| Initial Hematoma Volume | as measured by central reader (vs. rapid ABC/2 method used for initial qualification), in cubic centimeters estimated total volume | Mean | Standard Deviation | cubic centimeters |
| ||||||||||||||
| Baseline Measures of stroke symptom severity | As measured on ED arrival. The Glasgow Coma Scale (GCS) is most applicable in those critically ill and measures eye opening, verbal, and motor responses. Scores on the 3-component GCS may range from 3-15 and a lower score indicates a more severe condition. The National Institutes of Health Stroke Scale (NIHSS) is more sensitive for discerning subtle symptoms. Scores on the 11-component NIHSS may total between 0-42, with a higher score indicating a more severe stroke. ICH is an evolving condition and may worsen. NIHSS and GCS scores are used to measure changes in neurological status over time. | Median | Full Range | units on a scale |
| ||||||||||||||
| Duration of nicardipine infusion | in total hours, as measured from initial start to final stop of any nicardipine administration | Mean | Standard Deviation | hours |
| ||||||||||||||
| Maximum Dose of Nicardipine Used | in total milligrams, as calculated by rate per hour by nicardipine volume % for total hours of infusion | Mean | Standard Deviation | milligrams |
|
| 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 | Particpants Who Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier. | Feasibility of treatment was assessed by whether SBP reduction and maintenance within the respective target range was achieved (treatment success) or not (treatment failure), and secondarily by whether a significant difference between treatment arms was achieved. Treatment failure was defined based on the observed hourly hourly minimum SBP remaining greater than the upper limit of the target range for 2 consecutive hours after initiation of nicardipine infusion. Spontaneous decline of SBP below the lower limit of the specific tier was not considered treatment failure as all such declines were asymptomatic.The lower number in the more intensive treatment groups reflects in part the greater challenge of rapidly lowering systolic blood pressure to a more intensive (lower) range, as a higher number of treatment failures as pre-defined by meeting the SBP range goal within 3 hours of symptom onset in this group predictably occurred. | All subjects were evaluated for achievement of the treatment goals. | Posted | Number | participants | Within 3 hours of symptom onset and sustained through 18-24 hours. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Neurological Deteriorations (Decrease of 2 or More Points on the GCS Score or an Increase of 4 or More Points on the NIHSS Score) During the 24 Hour Treatment", | Neurological status was monitored quantitatively and independently of other adverse events using two scales. The Glasgow Coma Scale (GCS) score measures level of consciousness in eye, motor, and verbal components. At least one point is given in each category. The scale ranges from 3 to 15, with 3 indicating deep unconsciousness and 15 indicating consciousness is not impaired. The National Institutes of Health Stroke Scale (NIHSS) quantifies neurologic deficits in 11 categories. Level of consciousness, horizontal eye movements, visual fields, facial palsy, movement in each limb, sensation, language and speech, and extinction or inattention on one side of the body are tested. Scores range from 0 to 42; 0 indicates normal function and higher scores indicate greater deficit severity. | All subjects entered in the trial were followed and their data analyzed for safety measures. Not all subjects entered in the trial survived or remained in the trial to assess final outcomes at 1 or 3 months. When safety stopping rules could not have triggered after 18 initial subjects recruitment was adjusted to weight the subsequent tiers. | Posted | Number | participants | within the first 72 hours of treatment initiation |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Total Number of Serious Adverse Events Within the Initial 72 Hours From Treatment Per Subject | Serious adverse events were ascertained by site investigators using FDA-defined guidelines, defined as any untoward clinical events having been fatal, life-threatening, resulting in new or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage. Subjects were followed closely from randomization through 90 days. The initial 72-hour period was chosen as the most meaningful time period for which to examine SAEs likely to be related to the acute safety of the study treatment. | All subjects entered in the trial were followed and their data analyzed for safety measures. Not all subjects entered in the trial survived or remained in the trial to assess final outcomes at 1 or 3 months. When safety stopping rules could not have triggered after 18 initial subjects recruitment was adjusted to weight the subsequent tiers. | Posted | Count of Participants | Participants | from treatment initiation through 72 hours |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Particpants Who Tolerate Rapid Systolic Blood Pressure Reduction and Maintain Treatment Goals | The ability to maintain the Specified Systolic Blood Pressure Range for the 18-24 Hour Period without Neurological Deterioration or Side Effects | All subjects were analyzed by treatment arm for the presence of SAEs, neurological deterioration, symptomatic or asymptomatic hematoma expansion, and mortality in-hospital or within 3 months. Pre-specified safety stopping rules were used. The nature and relatedness of events was examined and overseen by an external Data safety and Monitoring Board. | Posted | Number | participants | 3 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Particpants Who Achieve Reduction of Blood Pressure and Maintain Treatment Goals (the Specified Systolic Blood Pressure Range for the 18-24 Hour Period) Without Neurological Deterioration or Side Effects Resulting in Death. | The tolerability of the study treatment was further ascertained by examination of in-hospital, 1-month, or 3-month mortality in each treatment group. This pilot study was not powered (did not plan to enroll an adequate number of patients) to draw meaningful conclusions about individual adverse event categories, outcome measures, or to make comparisons between the treatment arms beyond the overall feasibility and tolerability of rapidly and significantly lowering SBP following intracerebral hemorrhage. The timing and magnitude of SBP reduction was also compared to the timing of individual safety events to further evaluate possible relationships between the study treatment, adverse events, and any recognizable safety concerns. This information is available in publication but is not able to be displayed on this website due to formatting restrictions. | Serious adverse events were monitored for all patients throughout the 3-month study period; when mortality resulted death was categorized as having occurred prior to or following hospital discharge. The 3-month mortality count includes deaths that occurred earlier. Survival was confirmed at hospital discharge, 1 month, and 3 months. | Posted | Count of Participants | Participants | From enrollment through 3 months |
|
SAEs were collected from randomization through 90 +/- 14 days, but are reported through 72 hours (meaningful time in relation to treatment). Other AEs were collected through seven days from randomization or until hospital discharge, whichever came first.
Safety stopping rules were established in the protocol based on the upper limit (by 95% confidence interval) for individual and cumulative rates of neurologic deterioration and serious adverse events (SAE) from previous studies in a manner similar to other phase I trials in acute stroke patents. Safety data was monitored by the NIH-appointed DSMB.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tier 1 | Dose escalation: Initial range The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
The DSMB will review safety, tolerability, and feasibility before escalation to the next level. | 0 | 18 | 7 | 18 | ||
| EG001 | Tier 2 | Dose escalation: The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
The DSMB will review safety, tolerability, and feasibility before escalation to the next level. | 1 | 20 | 4 | 20 | ||
| EG002 | Tier 3 | Dose escalation: The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
| 3 | 22 | 7 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (4.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (4.1) | Systematic Assessment |
| |
| Acute respiratory distress syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | MedDRA (4.1) | Systematic Assessment |
| |
| Hyperglycemia and hypokalemia | Metabolism and nutrition disorders | MedDRA (4.1) | Systematic Assessment |
| |
| Symptomatic hematoma volume expansion | Nervous system disorders | MedDRA (4.1) | Systematic Assessment | defined as > 33 % increase in hematoma volume as measured by central reader between baseline and 24 hour head CT scans, accompanied by neurological deterioration or new neurological symptoms |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neurological deterioration within 24 hours | Nervous system disorders | MedDRA (4.1) | Systematic Assessment | defined as increase of 4 or more points on NIHSS or decrease of 2 or more points on GCS |
|
| Asymptomatic hematoma expansion | Nervous system disorders | MedDRA (4.1) | Systematic Assessment | Hematoma expansion is defined as > 33% increase in hematoma volume as measured by central reader between baseline and 24 hour head CT scans |
|
Limited by small sample size and likelihood of imbalances in subject characteristics among the three tiers. Clinical measures may be insensitive. Not designed to provide comparative event rates and not powered toward prediction of clinical outcomes.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adnan I Qureshi, MD | University of Minnesota | 612-624-2431 | qureshai@gmail.com |
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D006973 | Hypertension |
| D020521 | Stroke |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D009529 | Nicardipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Black |
|
| Others |
|
| Symptom onset to treatment initiation |
|
| Initial GCS |
|
|
| Treatment Failure, SBP not in range by 2 hours |
|
| Superiority or Other |
| OG001 | Tier 2 | Dose escalation: The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
The DSMB will review safety, tolerability, and feasibility before escalation to the next level. |
| OG002 | Tier 3 | Dose escalation: The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
|
|
|
|
| OG001 | Tier 2 | Dose escalation: The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
The DSMB will review safety, tolerability, and feasibility before escalation to the next level. |
| OG002 | Tier 3 | Dose escalation: The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
|
|
|
| OG002 | Tier 3 | Dose escalation: The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
|
|
|
| OG001 | Tier 2 | Dose escalation: The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
The DSMB will review safety, tolerability, and feasibility before escalation to the next level. |
| OG002 | Tier 3 | Dose escalation: The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
|
|
|