Antihypertensive Treatment in Acute Cerebral Hemorrhage

Conditions

• Hypertension
• Intracerebral Hemorrhage
• Stroke

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• nicardipine — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jul 31, 2005

Status verified

Nov 2017

Primary completion

Sep 30, 2007

Completion

Mar 31, 2008

Study Design

Enrollment

60 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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.
• 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.
• 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.

Primary Outcome Measure

Particpants Who Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier. [ Time Frame: Within 3 hours of symptom onset and sustained through 18-24 hours. ]

Locations (12)

Find similar trials in Los Angeles, CA

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