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

Completed · Phase 3

Conditions studied: Hypertension, Hemorrhage

In brief

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).

Key facts

Study ID

NCT00666328

Run by

The Medicines Company

People needed

37

Starts

2008-06-01

Expected to finish

2010-04-01

Last updated by the study team

2014-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Washington Hospital Center — Washington D.C., District of Columbia, United States
• The Queens Medical Center — Honolulu, Hawaii, United States
• The John Hopkins Hospital — Baltimore, Maryland, United States
• Maine Medical Center — Portland, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Columbia University Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Guilford Neurologic - Moses H Cone Health System — Greensboro, North Carolina, United States
• Cleveland Clinic Hospitals — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Thomas Jefferson University Stroke Research — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• The University Health Science Center at S.A. — San Antonio, Texas, United States
• Intermountain Medical Center — Murray, Utah, United States
• Universitätsklinikum Leipzig — Liebigstraße 22a, Leipzig, Germany
• Universitatsklinikum Erlangen — Erlangen, Germany
• Universitatsklinikum Heidelberg — Heidelberg, Germany

Full record on ClinicalTrials.gov

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