Clevidipine in the Treatment of Patients With Acute Hypertension and Intracerebral Hemorrhage (ACCELERATE)

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Medicines Company
• Treatments: Clevidipine

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