To evaluate the tolerability and safety of antihypertensive treatment as assessed by the achieving and maintaining systolic blood pressure goals with intravenous nicardipine infusion in subjects with ischemic stroke who present within 3 hours of symptoms onset.
- Nicardipine (Cardene)Drug
Other Names: Cardene, nicardipine hydrochloride Intervention Desc: Calcium channel blocker.
Enrolled subjects will be treated with intravenous nicardipine and will undergo follow-up for 90 days post treatment.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Tolerability of the treatment, defined as ability to achieve reduction of blood pressure and maintain treatment goals (the specified systolic blood pressure range for the 18-24 hour period) without incurring neurological deterioration or side effects that require termination of treatment. The primary safety endpoint is defined by a decline in GCS from pre-treatment assessment by 2 points or greater or increase in NIHSS score by 2 points or greater that is not explained by use of sedatives or hypnotics.|
|Secondary||Rate of serious adverse events related to nicardipine infusion, defined by a death or a life threatening adverse event or prolongation of hospitalization or persistent or significant disability. The tertiary outcome will be 3 months functional outcome, determined by Modified Ranking Scale and Barthel Index.|