Clevidipine in the Treatment of Patients With Acute Hypertension and Intracerebral Hemorrhage (ACCELERATE)
Condition: Hypertension; Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hypertension; Hemorrhage
Intervention: clevidipine
Intervention description: Clevidipine injectable emulsion (0.5 mg/mL) in 20% lipid emulsion in 100 mL bottles was administered intravenously to all patients via a single dedicated line.
Clevidipine was infused at an initial rate of 2.0 mg/h for the first 1.5 minutes. Thereafter, titration to higher infusion rates were to be attempted as needed to obtain the target systolic blood pressure (SBP) range (SBP ≤160 mmHg to ≥140 mmHg). Titration to effect was to proceed by doubling the dose every 1.5 minutes, up to a maximum of 32.0 mg/h, until the desired effect (SBP within the target range) was attained. The clevidipine infusion rate could be increased or decreased to maintain systolic blood pressure for up to a maximum of 96 hours.
Intervention MeSH terms: Clevidipine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension; Hemorrhage; Intracranial Pressure; Antihypertensive Agent; Calcium Channel Blocker

Summary:

      The purpose of this study was to determine the efficacy and safety of clevidipine for
      treating acute hypertension (high blood pressure, defined as systolic blood pressure >160
      mmHg) in patients with intracerebral hemorrhage (i.e., bleeding in the brain; stroke).
    

Eligibility criteria:

        Inclusion Criteria:

          -  CT evidence of intracerebral hemorrhage (diagnosis and treatment within 12 hours of
             symptom onset)

          -  Age 18 years or older

          -  Baseline systolic blood pressure (immediately prior to initiation of clevidipine) >160
             mmHg measured using an arterial line. ICP-monitored patients enrolled in the sub-study
             were enrolled if SBP at the time of enrollment was ≤160 mmHg

          -  Required antihypertensive therapy to achieve systolic blood pressure ≤160 mmHg

          -  Written informed consent obtained

        Exclusion Criteria:

          -  Decision for early surgical evacuation prior to 30 minutes of clevidipine

          -  Receipt of an oral antihypertensive within 2 hours prior to initiation of clevidipine

          -  Treatment with a continuous infusion of an IV antihypertension agent prior to
             initiation of clevidipine. Bolus treatment with urapidil (Germany only), labetalol or
             hydralazine was permitted. ICP-monitored patients enrolled in the sub-study could be
             enrolled with a continuous infusion of an IV antihypertensive agent prior to the
             initiation of clevidipine.

          -  Intracerebral hematoma considered to be related to trauma by the neurologist or
             neurosurgeon

          -  Aneurysmal sub-arachnoid hemorrhage

          -  Glasgow coma score of <5 and fixed dilated pupils

          -  Expectation that the patient would not tolerate or require intravenous
             antihypertensive therapy for a minimum of 30 minutes

          -  Known or suspected aortic dissection

          -  Acute myocardial infarction on presentation

          -  Positive pregnancy test or known pregnancy

          -  Intolerance or allergy to calcium channel blockers

          -  Allergy to soybean oil or egg lecithin

          -  Known liver failure, cirrhosis or pancreatitis

          -  Prior directives against advanced life support

          -  Participation in other clinical research studies involving the evaluation of other
             investigational drugs or devices within 30 days of enrollment