| Eligibility |
| Age-lower limit |
|
| Age-upper limit |
|
| Gender |
Male and Female |
| Key inclusion criteria |
1.IV nicardipine can be initiated within 4.5 hours of symptom onset
2.Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect
3.Total GCS score(aggregate of verbal, eye, & motor response scores) of 5 or greater at ED arrival
4.CT scan demonstrates intraparenchymal hematoma with manual hematoma volume measurement <60 cc
5.For subjects randomized prior to infusion start: Admission SBP greater than 180 mmHg but less than 240 mmHg AND WITHOUT spontaneous SBP reduction to below 180 mmHg at the time of randomization
OR
For subjects randomized after infusion start: Admission SBP greater than 180 mmHg but less than 240 mmHg AND WITHOUT SBP reduction to below 140 mmHg at the time of randomization
6.Informed consent obtained by subject, legally authorized representative, or next of kin
|
| Key exclusion criteria |
1.ICH is due to previously known neoplasms, AVM, or aneurysms
2.Intracerebral hematoma considered to be related to trauma
3.ICH located in infratentorial regions such as pons or cerebellum
4.IVH associated with intraparenchymal hemorrhage and blood completely fills one lateral ventricle or more than half of both ventricles
5.Patient to receive immediate surgical evacuation
6.Current pregnancy, parturition within previous 30 days or active lactation
7.Use of warfarin within the last 5 days and INR >4
8.A platelet count less than 50,000/mm3
9.Known sensitivity to nicardipine
10.Pre-morbid disability requiring assistance in ambulation or activities of daily living
11.Subjects living will precludes aggressive ICU management
12.Subject is currently participating in another interventional clinical trial
|
| Target sample size |
1280 |
| Result |
| URL related to results and publications |
https://www.nejm.org/doi/full/10.1056/NEJMoa1603460 |
| Number of participants that the trial has enrolled |
1000 |
| Results |
We conducted a multicenter trial where eligible subjects with ICH were randomized to intensive (<140 mm Hg) and standard (<180 mm Hg) SBP reduction in a 1:1 ratio <4.5h. The primary outcome of death and disability was ascertained at 3-M post randomization. Compared with standard SBP reduction, intensive SBP reduction in patients with ICH did not lower the rate of death and disability despite achieving a small magnitude reduction in hematoma expansion.
|
| Results date posted |
| 2019 |
Year |
03 |
Month |
12 |
Day |
|
| Results Delayed |
|
| Results Delay Reason |
|
| Date of the first journal publication of results |
| 2016 |
Year |
06 |
Month |
08 |
Day |
|
| Baseline Characteristics |
The mean pre-randomization systolic blood pressures were 200 mm Hg in to the intensive group and 201.1 mm Hg in the standard group. The proportion of subjects with Glasgow coma scale of 15 was similar (55 percent and 56.8 percent). The median hematoma volume was also similar (10.3 and 10.2 milliliters). Other demographic and baseline clinical characteristics were similar between the two groups. |
| Participant flow |
A total of 8,532 patients were screened for enrollment in the trial. The 1,000 subjects randomized were equally distributed (500 to intensive and 500 to standard treatment group). |
| Adverse events |
The proportion with hematoma expansion, defined as >33 percent increase in the hematoma volume from baseline to 24 hours, was 18.9 percent and 24.4 percent, for intensive and standard treatment groups, respectively (relative risk 0.78, 95 percent confidence interval 0.58, 1.03). |
| Outcome measures |
The proportion of death and disability at 3 months was observed in 186 of 481 (38.7 percent) subjects randomized to intensive treatment and 181 of 480 (37.7 percent) subjects randomized to standard treatment (relative risk of1.03, 95 percent confidence interval 0.84, 1.25 in intent to treat analysis), adjusted for age, initial Glasgow Coma scale, and presence/absence of intraventricular hemorrhage. |
| Plan to share IPD |
|
| IPD sharing Plan description |
|
| Progress |
| Recruitment status |
Completed |
| Date of protocol fixation |
| 2010 |
Year |
10 |
Month |
20 |
Day |
|
| Date of IRB |
| 2011 |
Year |
03 |
Month |
11 |
Day |
|
| Anticipated trial start date |
| 2011 |
Year |
10 |
Month |
01 |
Day |
|
| Last follow-up date |
| 2015 |
Year |
09 |
Month |
14 |
Day |
|
| Date of closure to data entry |
| 2016 |
Year |
02 |
Month |
10 |
Day |
|
| Date trial data considered complete |
| 2016 |
Year |
03 |
Month |
01 |
Day |
|
| Date analysis concluded |
| 2016 |
Year |
03 |
Month |
31 |
Day |
|
UMIN-CTR Clinical Trial