Hypertension in Acute Stroke TrEatment "HASTE"

Recruiting

Phase N/A Results N/A

Trial Description

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.

Interventions

  • Nicardipine (Cardene)Drug
    Other Names: Cardene, nicardipine hydrochloride
    Intervention Desc: Calcium channel blocker.

Patient Involvement

Enrolled subjects will be treated with intravenous nicardipine and will undergo follow-up for 90 days post treatment.

Outcomes

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.