TerminatedPhase 3

Antihypertensive Treatment of Acute Cerebral Hemorrhage-II

Stopped: Planned interim analysis: no significant outcome differences between groups

United States1,000 participantsStarted 2011-05-15

Plain-language summary

The specific aims of this study are to: 1. Definitively determine the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of patients with death and disability (mRS 4-6) at 3 months among subjects with ICH who are treated within 4.5 hours of symptom onset. 2. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the subjects' quality of life as measured by EuroQol at 3 months. 3. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of hematoma expansion (defined as increase from baseline hematoma volume of at least 33%) and in the change from baseline peri-hematoma volume at 24 hours on the serial computed tomographic (CT) scans. 4. Assess the safety of the intensive treatment relative to the standard treatment in the proportion of subjects with treatment-related serious adverse events (SAEs) within 72 hours.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 years or older * IV nicardipine can be initiated within 4.5 hours of symptom onset. * Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect. * Total Glasgow Coma Scale (GCS) score (aggregate of verbal, eye, and motor response scores) of 5 or greater at time of emergency department (ED) arrival. * International normalized ratio (INR) value \< 1.5 * CT scan demonstrates intraparenchymal hematoma with manual hematoma volume measurement \<60 cc. * For subjects randomized prior to IV antihypertensive administration: SBP greater than 180 mmHg\* prior to IV antihypertensive treatment (this includes pre-hospital treatment) AND WITHOUT spontaneous SBP reduction to below 180 mmHg at the time of randomization OR * For subjects randomized after IV antihypertensive administration: SBP greater than 180 mmHg\* prior to IV antihypertensive treatment (this includes pre-hospital treatment) AND WITHOUT SBP reduction to below 140 mmHg at the time of randomization. * Informed consent obtained by subject, legally authorized representative, or next of kin. * Notes: The unit "mmHg" stands for "millimeters of mercury", a standard way of measuring blood pressure. Patients with SBP \< 180 mmHg should be monitored for 4.5 hours from symptom onset as their SBP may rise to eligible levels before the eligibility window closes. Exclusion Criteria: * ICH is due to previously known…

What they're measuring

Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization

Timeframe: 90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization

Trial details

NCT IDNCT01176565

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12-21

Results submitted2017-01-01