Trial · NCT00415610
Antihypertensive Treatment in Acute Cerebral Hemorrhage
NCT00415610, Phase 1, Completed, University of Minnesota; results first posted 2015-09-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Antihypertensive Treatment in Acute Cerebral Hemorrhage. Trials, record NCT00415610. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00415610
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antihypertensive Treatment in Acute Cerebral Hemorrhage
- NCT number
- NCT00415610
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 60 participants, actual
- Lead sponsor
- University of Minnesota
- Conditions
- Intracerebral Hemorrhage, Hypertension, Stroke
- Interventions
- nicardipine
- First posted
- 2006-12-25
- Last updated
- 2017-11-21
- Results first posted
- 2015-09-07
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Particpants Who Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier. | Within 3 hours of symptom onset and sustained through 18-24 hours. | 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. |
| 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", | within the first 72 hours of treatment initiation | 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. |
| Primary | Total Number of Serious Adverse Events Within the Initial 72 Hours From Treatment Per Subject | from treatment initiation through 72 hours | 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. |
| Secondary | Particpants Who Tolerate Rapid Systolic Blood Pressure Reduction and Maintain Treatment Goals | 3 months | The ability to maintain the Specified Systolic Blood Pressure Range for the 18-24 Hour Period without Neurological Deterioration or Side Effects |
| Other | 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. | From enrollment through 3 months | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Particpants Who Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier. | Within 3 hours of symptom onset and sustained through 18-24 hours. | All subjects were evaluated for achievement of the treatment goals. | participants | NUMBER |
| 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, | within the first 72 hours of treatment initiation | 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. | participants | NUMBER |
| PRIMARY | Total Number of Serious Adverse Events Within the Initial 72 Hours From Treatment Per Subject | from treatment initiation through 72 hours | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Particpants Who Tolerate Rapid Systolic Blood Pressure Reduction and Maintain Treatment Goals | 3 months | 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. | participants | NUMBER |
| 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. | From enrollment through 3 months | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Particpants Who Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier. | Tier 1 | Meeting Criteria of initial SBP > 170 mmHg | 18 | participants | |
| Particpants Who Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier. | Tier 2 | Meeting Criteria of initial SBP > 170 mmHg | 20 | participants | |
| Particpants Who Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier. | Tier 3 | Meeting Criteria of initial SBP > 170 mmHg | 22 | participants | |
| Particpants Who Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier. | Tier 1 | Number treated within 3 hours of symptom onset | 7 | participants | |
| Particpants Who Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier. | Tier 2 | Number treated within 3 hours of symptom onset | 5 | participants | |
| Particpants Who Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier. | Tier 3 | Number treated within 3 hours of symptom onset | 6 | participants | |
| Particpants Who Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier. | Tier 1 | Treatment Failure, SBP not in range by 2 hours | 0 | participants | |
| Particpants Who Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier. | Tier 2 | Treatment Failure, SBP not in range by 2 hours | 0 | participants | |
| Particpants Who Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier. | Tier 3 | Treatment Failure, SBP not in range by 2 hours | 9 | participants | |
| 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, | Tier 1 | 1 | participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tier 1 | 18 | |
| Overall Study | STARTED | Tier 2 | 20 | |
| Overall Study | STARTED | Tier 3 | 22 | |
| Overall Study | COMPLETED | Tier 1 | 15 | |
| Overall Study | COMPLETED | Tier 2 | 18 | |
| Overall Study | COMPLETED | Tier 3 | 17 | |
| Overall Study | NOT COMPLETED | Tier 1 | 3 | |
| Overall Study | NOT COMPLETED | Tier 2 | 2 | |
| Overall Study | NOT COMPLETED | Tier 3 | 5 |
Source ClinicalTrials.gov
Adverse events21
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neurological deterioration within 24 hours | Nervous system disorders | Tier 1 | 1 | 18 | 1 |
| other | Neurological deterioration within 24 hours | Nervous system disorders | Tier 2 | 2 | 20 | 2 |
| other | Neurological deterioration within 24 hours | Nervous system disorders | Tier 3 | 4 | 22 | 4 |
| other | Asymptomatic hematoma expansion | Nervous system disorders | Tier 1 | 6 | 18 | 6 |
| other | Asymptomatic hematoma expansion | Nervous system disorders | Tier 2 | 2 | 20 | 2 |
| other | Asymptomatic hematoma expansion | Nervous system disorders | Tier 3 | 3 | 22 | 3 |
| serious | Respiratory distress | Respiratory, thoracic and mediastinal disorders | Tier 1 | 0 | 18 | 0 |
| serious | Respiratory distress | Respiratory, thoracic and mediastinal disorders | Tier 2 | 1 | 20 | 1 |
| serious | Respiratory distress | Respiratory, thoracic and mediastinal disorders | Tier 3 | 0 | 22 | 0 |
| serious | Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Tier 1 | 0 | 18 | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tier 1 | ||
| Total, all-cause mortality | Tier 2 | ||
| Total, all-cause mortality | Tier 3 | ||
| Total, other adverse events | Tier 1 | 7 | 18 |
| Total, other adverse events | Tier 2 | 4 | 20 |
| Total, other adverse events | Tier 3 | 7 | 22 |
| Total, serious adverse events | Tier 1 | 0 | 18 |
| Total, serious adverse events | Tier 2 | 1 | 20 |
| Total, serious adverse events | Tier 3 | 3 | 22 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01NS044976 | Antihypertensive Treatment in Acute Cerebral Hemorrhage | QURESHI, ADNAN IQBAL | UNIVERSITY OF MINNESOTA | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2004 to 2006 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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