Trial · NCT01176565
Antihypertensive Treatment of Acute Cerebral Hemorrhage-II
NCT01176565, Phase 3, Terminated, University of Minnesota; results first posted 2017-04-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Antihypertensive Treatment of Acute Cerebral Hemorrhage-II. Trials, record NCT01176565. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01176565
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antihypertensive Treatment of Acute Cerebral Hemorrhage-II
- NCT number
- NCT01176565
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,000 participants, actual
- Lead sponsor
- University of Minnesota
- Conditions
- Intracerebral Hemorrhage
- Interventions
- Intravenous nicardipine hydrochloride
- First posted
- 2010-08-06
- Last updated
- 2017-04-25
- Results first posted
- 2017-04-25
- Limitations and caveats
Treatment failures, randomization window, demographics, pre-randomization treatment, low death/disability, favorable baselines, and early termination could limit generalizability of primary (all with intent-to-treat) results and some sub-analyses.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization | 90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization | The primary outcome was death or disability, defined by modified Rankin scale (mRS) of 4-6 at 90 days following treatment. The modified Rankin Scale score ranges from 0, indicating no symptoms, to 6, indicating death. A score of 4 indicates moderately severe disability including the inability to walk or attend to one's own bodily needs. A score of 5 indicates severe disability; bedridden, incontinent, and requiring constant nursing care. To score a 3 or lower on the mRS, a person must at least be able to walk without the assistance of another person. We chose the mRS because of its high inter-observer reliability, superiority to other indices, and consistency with previous trials in patients with ICH. Reliability was further increased by use of a structured interview template and by requiring mRS assessors to pass a certification test. Persons conducting the 90-day mRS assessment were to be unaware of the treatment arm or clinical course of the patients they assessed. |
| Secondary | Quality of Life at 90 Days Using EuroQol (EQ) Measures: EQ-5D (EuroQol Five Dimension), Consisting of Standardized EQ-5D-3L (EuroQol Five Dimension, Three-Level) Questionnaire and EQ VAS (EuroQol Visual Analog Scale) Scores | 90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization | Standardized scales developed by the EuroQol Research Foundation were used as a secondary outcome measure in addition to the mRS scale score. The EQ-5D is a simple, standardized non-disease-specific instrument for describing and valuating health-related quality of life. The EQ-5D-3L questionnaire consists of 5 questions in 5 different domains and allows for responses from 1 (the best outcome) to 3 (the worst outcome) in each of five categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Total scores range from 5 to 15, with lower scores indicating better quality of life and a higher score indicating a worse quality of life. A second component of EuroQol outcome measurements is a printed 20 cm visual analogue scale (EQ VAS) that appears somewhat like a thermometer, on which a score from 0 (worst imaginable health state or death) to 100 (best imaginable health state) is marked by the patient (or, when necessary, their proxy) with the scale in view. |
| Secondary | Hematoma Expansion (Number of Patients With Hematoma Expansion of 33% or Greater Between the Baseline and 24 +/- 6 Hours Head CTs, as Measured by the Central Reader for Patients With Readable Scans for Both Time Points Submitted by Data Lock.) | From the baseline head CT to the 24 +/- 6 hours from randomization head CT | Hematoma expansion as determined by serial CT scans: Hematoma expansion was defined as an increase in the volume of intraparenchymal hemorrhage of 33% or greater as measured by a central imaging analyst who was was unaware of the treatment assignments, clinical findings, and time points of image acquisition. The area of the hematoma was delineated by image analysis software with the use of density thresholds on each slice, followed by manual correction. To ensure accuracy and consistency of the readings, images were coded randomly and independently of subject numbers and manual correction was also done without awareness of treatment assignments, clinical findings, or time points of image acquisition. This data point is defined as being present (hematoma expansion of 33% or more was calculated between the baseline scan hematoma volume and the 24 +/- 6 hours hematoma volume measures at data analysis), meaning that hematoma expansion as defined must have occurred or it was not counted. |
| Other | Neurological Deterioration Within 24 Hours, Defined by a Decrease of 2 or More Points on the GCS Score or an Increase of 4 or More Points on the NIHSS Score From Baseline, Not Related to Sedation or Hypnotic-agent Use and Sustained for at Least 8 Hours. | From randomization through the 24-hour treatment period | Neurologic deterioration was measured using two scales. The Glasgow Coma Scale (GCS) score measures of 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 movement, visual fields, facial palsy, movement in each limb, sensation, language \& speech, and extinction or inattention on one side of the body are tested. Scores range from 0 to 42, with 0 indicating normal function and higher scores indicating greater deficit severity. Neurological status was checked per ICU standards through 24 hours, recommended as hourly GCS and full assessment every 2 hours. NIHSS assessment at baseline and 24 +/- 3 hours was pre-specified. Assessments were added for suspected neurological change. |
| Other | Hypotension Within 72 Hours | From randomization through 72 hours from randomization | Hypotension (abnormally low blood pressure) was the most likely adverse event that could be associated with the study treatment, and is the primary basis (risk) on which neurological deterioration or other untoward effects of the study treatment could occur. It is therefore examined as a numerically-measured occurrence in addition to monitoring patients closely for neurological deterioration or other symptoms. Hypotension, when named as an adverse event, was defined as the syndrome of low blood pressure with SBP \< 85 mmHg. Instances of hypotension were to be avoided through close monitoring, and administration of fluid bolus for SBP \< 110 mmHg. If hypotension did occur, it was to be reversed as quickly as possible through discontinuation of intravenous nicardipine and intravenous fluid administration, which can be accomplished readily in a variety of settings where patients with intracerebral hemorrhage are routinely housed during early hospitalization. |
| Other | Treatment-related Serious Adverse Event Within 72 Hours of Randomization | From randomization through 72 hours (3 days) | Adverse events (AEs) and serious adverse events (SAEs) were assessed by the site investigators for all patients, including for their potential relatedness to the study treatment. An Independent Oversight Committee (IOC) reviewed and adjudicated all adverse event data. The 72-hours-from-randomization time window was considered the most likely time frame during which treatment-related adverse events or serious adverse events would be observed. Terminology from the Medical Dictionary for Regulatory Activities (MedDRA) and severity criteria from the Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) were used as a basis for reporting adverse events. Serious adverse events are defined as being fatal, life-threatening, resulting in hospitalization or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage and were required to be reported promptly. |
| Other | Any Serious Adverse Event Within the 90-day Study Period | From randomization through the 90 day visit (90 ± 14 days per protocol window; up to ± 30 days data is used) or until known death, withdrawal, or loss to follow-up. | The complete count of all subjects who experienced any serious adverse events throughout their participation in the trial was included in this tabulation. Adverse events (AEs) and serious adverse events (SAEs) were assessed by the site investigators for all patients. Potential relatedness to the study treatment was a required reporting element for all adverse events but was not considered in this count. Terminology from the Medical Dictionary for Regulatory Activities (MedDRA) and severity criteria from the Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) were used as a basis for reporting adverse events. Serious adverse events are defined as being fatal, life-threatening, resulting in hospitalization or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage and were required to be reported promptly. An Independent Oversight Committee (IOC) reviewed and adjudicated adverse event data. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization | 90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization | All subjects were analyzed for known death at any time following randomization. Patients surviving through 90 days (± 14 days per protocol window; data used up to ± 30 days) were assessed for disability using the mRS. Patients not completing the 90-day visit within 30 days of due date aren't included in the death \& disability participant counts. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Quality of Life at 90 Days Using EuroQol (EQ) Measures: EQ-5D (EuroQol Five Dimension), Consisting of Standardized EQ-5D-3L (EuroQol Five Dimension, Three-Level) Questionnaire and EQ VAS (EuroQol Visual Analog Scale) Scores | 90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization | All available valid data were analyzed. Outcomes collected outside of 90 ± 30 days weren't considered valid. EQ-5D data were missing for 28 patients in the intensive group \& for 27 in the standard group. EQ VAS data were missing for 144 patients in the intensive group and for 146 in the standard group. | units on a scale | MEDIAN |
| SECONDARY | Hematoma Expansion (Number of Patients With Hematoma Expansion of 33% or Greater Between the Baseline and 24 +/- 6 Hours Head CTs, as Measured by the Central Reader for Patients With Readable Scans for Both Time Points Submitted by Data Lock.) | From the baseline head CT to the 24 +/- 6 hours from randomization head CT | Participants with readable head CTs at baseline and 24 +/- 6 hours from randomization (submitted before data lock) were analyzed. Hematoma expansion was only recorded as present if ≥ 33% volume increase was calculated. Scans done outside of time window + margin, submitted after data lock, or not readable in standard DICOM format could not be used. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Neurological Deterioration Within 24 Hours, Defined by a Decrease of 2 or More Points on the GCS Score or an Increase of 4 or More Points on the NIHSS Score From Baseline, Not Related to Sedation or Hypnotic-agent Use and Sustained for at Least 8 Hours. | From randomization through the 24-hour treatment period | All subjects were assessed for neurological status regularly. Grid-estimated verbal scoring based on eye and motor scores was used for intubated patients so that GCS scores could be compared over time and was consistent across patients. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Hypotension Within 72 Hours | From randomization through 72 hours from randomization | Blood pressure including the potential for hypotension was monitored according to intensive care unit standards for ICH patients during early hospitalization. Blood pressure was monitored more closely during the 24-hour study period and at times when nicardipine (or other/secondary IV antihypertensive medications) were being titrated. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Treatment-related Serious Adverse Event Within 72 Hours of Randomization | From randomization through 72 hours (3 days) | Relatedness is defined by the terms unrelated, unlikely, possibly, probably, or definitely related to the study treatment. Results are entered as the count of participants experiencing any serious adverse event within 72 hours of randomization that was determined by the site investigator to possibly or more have relationship to the study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Any Serious Adverse Event Within the 90-day Study Period | From randomization through the 90 day visit (90 ± 14 days per protocol window; up to ± 30 days data is used) or until known death, withdrawal, or loss to follow-up. | Patients may have experienced more than one adverse event. This measure is designed to show the total count of any patients who experienced any type of serious adverse event, whether it was felt to be related to the study treatment or not, throughout the duration of their participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization | Standard SBP Reduction Arm | Death or disability at 90 days (mRS = 4 - 6) | 181 | Participants | |
| Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization | Intensive SBP Reduction Arm | Death or disability at 90 days (mRS = 4 - 6) | 186 | Participants | |
| Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization | Standard SBP Reduction Arm | Known death at or before 90 days | 34 | Participants | |
| Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization | Intensive SBP Reduction Arm | Known death at or before 90 days | 33 | Participants | |
Quality of Life at 90 Days Using EuroQol (EQ) Measures: EQ-5D (EuroQol Five Dimension), Consisting of Standardized EQ-5D-3L (EuroQol Five Dimension, Three-Level) Questionnaire and EQ VAS (EuroQol Visual Analog Scale) Scores | Standard SBP Reduction Arm | EQ-5D utility scale questionnaire | 0.7 | Full Range 0 to 1.0 | units on a scale |
Quality of Life at 90 Days Using EuroQol (EQ) Measures: EQ-5D (EuroQol Five Dimension), Consisting of Standardized EQ-5D-3L (EuroQol Five Dimension, Three-Level) Questionnaire and EQ VAS (EuroQol Visual Analog Scale) Scores | Intensive SBP Reduction Arm | EQ-5D utility scale questionnaire | 0.7 | Full Range -0.109 to 1.0 | units on a scale |
Quality of Life at 90 Days Using EuroQol (EQ) Measures: EQ-5D (EuroQol Five Dimension), Consisting of Standardized EQ-5D-3L (EuroQol Five Dimension, Three-Level) Questionnaire and EQ VAS (EuroQol Visual Analog Scale) Scores | Standard SBP Reduction Arm | EQ VAS (visual analog scale) | 70 | Full Range 0 to 100 | units on a scale |
Quality of Life at 90 Days Using EuroQol (EQ) Measures: EQ-5D (EuroQol Five Dimension), Consisting of Standardized EQ-5D-3L (EuroQol Five Dimension, Three-Level) Questionnaire and EQ VAS (EuroQol Visual Analog Scale) Scores | Intensive SBP Reduction Arm | EQ VAS (visual analog scale) | 62.5 | Full Range 0 to 100 | units on a scale |
Hematoma Expansion (Number of Patients With Hematoma Expansion of 33% or Greater Between the Baseline and 24 +/- 6 Hours Head CTs, as Measured by the Central Reader for Patients With Readable Scans for Both Time Points Submitted by Data Lock.) | Standard SBP Reduction Arm | 104 | Participants | ||
Hematoma Expansion (Number of Patients With Hematoma Expansion of 33% or Greater Between the Baseline and 24 +/- 6 Hours Head CTs, as Measured by the Central Reader for Patients With Readable Scans for Both Time Points Submitted by Data Lock.) | Intensive SBP Reduction Arm | 85 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard SBP Reduction Arm | 500 | |
| Overall Study | STARTED | Intensive SBP Reduction Arm | 500 | |
| Overall Study | COMPLETED | Standard SBP Reduction Arm | 480 | |
| Overall Study | COMPLETED | Intensive SBP Reduction Arm | 481 | |
| Overall Study | NOT COMPLETED | Standard SBP Reduction Arm | 20 | |
| Overall Study | NOT COMPLETED | Intensive SBP Reduction Arm | 19 |
Source ClinicalTrials.gov
Adverse events862
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 | Abdominal discomfort | Gastrointestinal disorders | Standard SBP Reduction Arm | 0 | 500 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Intensive SBP Reduction Arm | 1 | 500 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Standard SBP Reduction Arm | 1 | 500 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Intensive SBP Reduction Arm | 0 | 500 | 0 |
| other | Abscess limb | Injury, poisoning and procedural complications | Standard SBP Reduction Arm | 0 | 500 | 0 |
| other | Abscess limb | Injury, poisoning and procedural complications | Intensive SBP Reduction Arm | 1 | 500 | 1 |
| other | Activated partial thromboplastin time prolonged | Investigations | Standard SBP Reduction Arm | 1 | 500 | 1 |
| other | Activated partial thromboplastin time prolonged | Investigations | Intensive SBP Reduction Arm | 0 | 500 | 0 |
| other | Acute myocardial infarction | Cardiac disorders | Standard SBP Reduction Arm | 1 | 500 | 1 |
| other | Acute myocardial infarction | Cardiac disorders | Intensive SBP Reduction Arm | 0 | 500 | 0 |
1 to 10 of 862Source ClinicalTrials.gov
See all 862 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard SBP Reduction Arm | ||
| Total, all-cause mortality | Intensive SBP Reduction Arm | ||
| Total, other adverse events | Standard SBP Reduction Arm | 500 | 500 |
| Total, other adverse events | Intensive SBP Reduction Arm | 500 | 500 |
| Total, serious adverse events | Standard SBP Reduction Arm | 100 | 500 |
| Total, serious adverse events | Intensive SBP Reduction Arm | 128 | 500 |
Source ClinicalTrials.gov
Papers36
The papers the trial lists on ClinicalTrials.gov.
Grants4
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 | Source |
|---|---|---|---|---|---|---|
| U01NS056975 | Neurologic Emergencies Treatment Trials Network: Clinical Coordinating Center | BARSAN, WILLIAM G | UNIVERSITY OF MICHIGAN AT ANN ARBOR | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2006 to 2015 | NIH RePORTER |
| U01NS059041 | Neurological Emergencies Treatment Trial Network Statistical/Data Management Ctr | DURKALSKI, VALERIE L; PALESCH, YUKO Y | MEDICAL UNIVERSITY OF SOUTH CAROLINA | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2006 to 2015 | NIH RePORTER |
| U01NS061861 | Statistical and Data Coordinating Center for the ATACH - 2 | PALESCH, YUKO Y | MEDICAL UNIVERSITY OF SOUTH CAROLINA | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2010 to 2014 | NIH RePORTER |
| U01NS062091 | Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II) | QURESHI, ADNAN IQBAL | UNIVERSITY OF MINNESOTA | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2010 to 2014 | NIH RePORTER |
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Standard SBP Reduction Arm vs Intensive SBP Reduction Arm: Hematoma Expansion (Number of Patients With Hematoma Expansion of 33% or Greater Between the Baseline and 24 +/- 6 Hours Head CTs, as Measured by the Central Reader for Patients With Readable Scans for Both Time Points Submitted by Data Lock.) | Trial comparisons |
| Standard SBP Reduction Arm vs Intensive SBP Reduction Arm: Any Serious Adverse Event Within the 90-day Study Period | Trial comparisons |
| Standard SBP Reduction Arm vs Intensive SBP Reduction Arm: Hypotension Within 72 Hours | Trial comparisons |
Standard SBP Reduction Arm vs Intensive SBP Reduction Arm: Neurological Deterioration Within 24 Hours, Defined by a Decrease of 2 or More Points on the GCS Score or an Increase of 4 or More Points on the NIHSS Score From Baseline, Not Related to Sedation or Hypnotic-agent Use and Sustained for at Least 8 Hours. | Trial comparisons |
| Standard SBP Reduction Arm vs Intensive SBP Reduction Arm: Treatment-related Serious Adverse Event Within 72 Hours of Randomization | Trial comparisons |
| Standard SBP Reduction Arm vs Intensive SBP Reduction Arm: serious adverse events | Trial comparisons |
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.
GET https://conductscience.org/api/trials/v1/NCT01176565
GET https://conductscience.org/api/trials/v1/NCT01176565/events?page=2