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CompletedNCT00415610ATACHUpdated Nov 21, 2017Results posted

Antihypertensive Treatment in Acute Cerebral Hemorrhage

A Phase 1 interventional study of nicardipine in Intracerebral Hemorrhage, Hypertension and Stroke, sponsored by University of Minnesota. Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-21.

Sponsored by University of Minnesota · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Intracerebral Hemorrhage
  • Hypertension
  • Stroke

Keywords

  • cerebral hemorrhage
  • intracerebral hemorrhage
  • stroke
  • hypertension
  • blood pressure
  • nicardipine
  • antihypertensive agent
  • hematoma expansion
03

In context

Cerebral Hemorrhage

476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.

This study's enrollment of 60 is below the median of 100 across 287 interventional studies indexed under Cerebral Hemorrhage.

Browse Cerebral Hemorrhage studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age older than 18 years.
  • Onset of new neurological signs of a stroke within 12 hours of the time to evaluation AND initiation of treatment with intravenous nicardipine.
  • Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect.
  • The total GCS score is greater than 8 at the time of enrollment.
  • CT scan demonstrates intraparenchymal hematoma with manual hematoma volume measurement less than 60 cc.
  • ICH is supratentorial and is located in lobar, basal ganglionic, or thalamic based on the initial CT scan appearance.
  • Admission systolic blood pressure greater than 170 mm Hg on two repeat measurements at least 5 minutes apart.
  • Evidence of chronic hypertension.
  • Subject is not considered a surgical candidate by the neurosurgery service.

Exclusion criteria

Exclusion Criteria:

  • Time of symptom onset cannot be reliably assessed.
  • Previously known neoplasms, arteriovenous malformation, or aneurysms.
  • Intracerebral hematoma considered to be related to trauma by the neurologist or neurosurgeon.
  • ICH is located in the cortex or infratentorial regions such as pons or cerebellum.
  • Blood is visualized in the subarachnoid space.
  • Intravenous nicardipine cannot be initiated within 12 hours of symptom onset.
  • Use of clonidine hydrochloride and other central alpha-agonist within the last 48 hours that have the potential of withdrawal hypertension.
  • Pregnancy, lactation, or parturition within previous 30 days.
  • Any history of bleeding diathesis or coagulopathy, including the use of warfarin.
  • Use of heparin in the previous 48 hours and a prolonged partial thromboplastin time.
  • Known atrial-ventricular heart block other than first degree, or sick sinus syndrome without a pacemaker.
  • Intolerance to calcium channel blockers.
  • Exposure to study medication in the preceding 24 hours prior to enrollment.
  • A platelet counts less than 100 000/mm3.
  • Major surgery within the previous six weeks.
  • History of any intracranial hemorrhage (including intracerebral or subarachnoid hemorrhage) or hemorrhagic stroke.
  • Seizure at onset of stroke.
  • Blood glucose less than 50 mg/dL or greater than 400 mg/dL.
  • Current participation in another research drug treatment protocol.
  • Isolated ventricular blood on CT scan.
  • Subject has a living will that precludes aggressive intensive care unit management.
  • Subject has acute myocardial infarction or renal failure that precludes use of aggressive antihypertensive therapy.
  • Subjects with unstable angina or acute myocardial infarction within 2 weeks prior to ICH.
  • Subjects with renal insufficiency with serum creatinine greater than 2.0 mg/dl or on renal dialysis.
  • Sinus tachycardia exceeding 120 beats per minute or supraventricular tachycardia is observed during initial evaluation.
  • Ischemic stroke within 4 weeks of presentation.
  • Congestive heart failure graded as class III and IV by New York Heart Association (NYHA) classification.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Other
    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.

    Drug: nicardipine

  • Other
    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.

    Drug: nicardipine

  • Other
    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.

    Drug: nicardipine

Interventions

  • Drugnicardipine

    Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours. * Started at 5mg/h * Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour \*Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.

    Also known as: Cardene, nicardipine hydrochloride

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 3 hours of symptom onset and sustained through 18-24 hours.

  2. 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.

    Time frame: within the first 72 hours of treatment initiation

  3. 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.

    Time frame: from treatment initiation through 72 hours

Secondary outcomes

  1. 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

    Time frame: 3 months

Other outcomes

  1. 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.

    Time frame: From enrollment through 3 months

07

Results

Posted Sep 7, 2015
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.

Participant flow

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.

Participant flow — Overall Study
MilestoneTier 1Tier 2Tier 3
Started182022
Completed151817
Not completed325
Withdrew: Death325

Outcome measures

PrimaryParticpants 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.

Time frame:
Within 3 hours of symptom onset and sustained through 18-24 hours.
Reported as:
Number · participants
Particpants Who Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier.
participantsTier 1Tier 2Tier 3
Meeting Criteria of initial SBP > 170 mmHg182022
Number treated within 3 hours of symptom onset756
Treatment Failure, SBP not in range by 2 hours009
Statistical analysis
  • Tier 1 vs Tier 2 vs Tier 3 · repeated measure · p = < 0.01 (The repeated measure analysis of the hourly average SBP was calculated with and without adjusting for baseline NIHSS and age.)Adjusted for initial deficit severity of using baseline NIHSS instead of GCS to better discriminate among patients with GCS score \> 8.
PrimaryNumber 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.

Time frame:
within the first 72 hours of treatment initiation
Reported as:
Number · 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",
participantsTier 1Tier 2Tier 3
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",124
Statistical analysis
  • Tier 1 vs Tier 2 vs Tier 3 · Wilcoxon rank sum test · p = < .5 (Observed average SBP change at 2 hrs after treatment initiation between subjects who did or did not have neurologic deterioration within 24 hrs.)Mean decrease measured for subjects with neurological deterioration and subjects without neurological deterioration.
PrimaryTotal 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.

Time frame:
from treatment initiation through 72 hours
Reported as:
Count of participants · Participants
Total Number of Serious Adverse Events Within the Initial 72 Hours From Treatment Per Subject
ParticipantsTier 1Tier 2Tier 3
Total Number of Serious Adverse Events Within the Initial 72 Hours From Treatment Per Subject013
SecondaryParticpants 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

Time frame:
3 months
Reported as:
Number · participants
Particpants Who Tolerate Rapid Systolic Blood Pressure Reduction and Maintain Treatment Goals
participantsTier 1Tier 2Tier 3
N with SAE within 72 hours013
N with neurologic deterioration within 24 hours124
N with symptomatic hematoma expansion014
N with asymptomatic hematoma expansion623
N with in-hospital mortality211
N with 3-month mortality325
N with 1-month favorable outcome, mRS 0-2464
N missing for 1-month outcome assessment332
N with 3-month favorable outcome, mRS 0-2897
N missing for 3-month outcome assessment342
Other pre-specifiedParticpants 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.

Time frame:
From enrollment through 3 months
Reported as:
Count of participants · Participants
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.
ParticipantsTier 1Tier 2Tier 3
In-hospital mortality211
Mortality at 3 months (also in participant flow)325
Survival/no known death at 1 or 3 months (derived)131716

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tier 1—0/18 (0%)7/18 (38.9%)
Tier 2—1/20 (5%)4/20 (20%)
Tier 3—3/22 (13.6%)7/22 (31.8%)
Most frequent serious events
Most frequent serious events
EventTier 1Tier 2Tier 3
Respiratory distressRespiratory, thoracic and mediastinal disorders0/181/200/22
Symptomatic hematoma volume expansionNervous system disorders0/181/200/22
Acute respiratory failureRespiratory, thoracic and mediastinal disorders0/180/201/22
Acute respiratory distress syndrome (ARDS)Respiratory, thoracic and mediastinal disorders0/180/201/22
Hyperglycemia and hypokalemiaMetabolism and nutrition disorders0/180/201/22
Most frequent other events
Most frequent other events
EventTier 1Tier 2Tier 3
Asymptomatic hematoma expansionNervous system disorders6/182/203/22
Neurological deterioration within 24 hoursNervous system disorders1/182/204/22

Baseline characteristics

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.

Age, Continuous
Age, Continuous(years)Tier 1Tier 2Tier 3Total
Mean62 ± 17.758.5 ± 13.065.1 ± 14.662 ± 15.1
Sex: Female, Male
Sex: Female, Male(Participants)Tier 1Tier 2Tier 3Total
Female98926
Male9121334
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Tier 1Tier 2Tier 3Total
White5131331
Black117725
Others2024
Region of Enrollment
Region of Enrollment(participants)Tier 1Tier 2Tier 3Total
United States18202260
Baseline Measures - Timing of Treatment
Baseline Measures - Timing of Treatment(hours)Tier 1Tier 2Tier 3Total
Symptom onset to emergency department arrival1.72 ± 1.271.70 ± 1.131.86 ± 1.781.72 ± 1.37
Symptom onset to treatment initiation3.94 ± 1.454.13 ± 1.504.44 ± 2.084.19 ± 1.71
Initial SBP
Initial SBP(millimeters of mercury (mmHg))Tier 1Tier 2Tier 3Total
Median209 (178 to 255)212 (190 to 275)201 (171 to 300)208 (171 to 300)
Initial Hematoma Volume
Initial Hematoma Volume(cubic centimeters)Tier 1Tier 2Tier 3Total
Mean15.45 ± 14.6014.84 ± 17.1510.94 ± 10.8713.56 ± 14.24
Baseline Measures of stroke symptom severity
Baseline Measures of stroke symptom severity(units on a scale)Tier 1Tier 2Tier 3Total
Initial NIHSS score11 (2 to 40)9 (0 to 25)8 (3 to 34)10 (0 to 40)
Initial GCS14 (9 to 15)15 (8 to 15)15 (9 to 15)15 (8 to 15)

2 further baseline measures are reported on the registry.

08

Study locations

12 sites
  • University of Southern California
    Los Angeles, California 90033, United States
  • Kansas University Medical Center
    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
    Saint 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
09

References and documents

Publications

  • 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. PubMed 17356194 ↗
  • 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. PubMed 20457956 ↗
  • 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. PubMed 19770736 ↗
  • 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. PubMed 18606927 ↗
  • 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. PubMed 22560810 ↗
  • 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. PubMed 21626077 ↗
  • 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. PubMed 23233387 ↗

Individual participant data

Plan to share: Undecided — consult investigator for options

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00415610
Lead sponsor
University of Minnesota
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Responsible party
Sponsor
First posted
Dec 25, 2006
Start date
Jul 2005
Primary completion
Sep 2007
Completion
Mar 2008
Results posted
Sep 7, 2015
Last update
Nov 21, 2017

Study contacts

Adnan I. Qureshi, MD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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