Status:
COMPLETED
Clevidipine in the Treatment of Patients With Acute Hypertension and Intracerebral Hemorrhage (ACCELERATE)
Lead Sponsor:
The Medicines Company
Conditions:
Hypertension
Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
This was a multicenter, single-arm, non-blinded dose titration efficacy and safety trial evaluating the ability of clevidipine, a vascular-selective L-type calcium channel antagonist, to rapidly contr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00666328
Start Date
June 1 2008
End Date
April 1 2010
Last Update
August 29 2014
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010-2975
2
The Queens Medical Center
Honolulu, Hawaii, United States, 96813
3
The John Hopkins Hospital
Baltimore, Maryland, United States, 21287
4
Maine Medical Center
Portland, Massachusetts, United States, 04102