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Clinical Trials/EUCTR2008-000230-53-DE
EUCTR2008-000230-53-DE
Active, not recruiting
Not Applicable

The evaluation of patients with acute hypertension and intracerebral hemorrhage with intravenous clevidipine treatment - ACCELERATE

The Medicines Company0 sites60 target enrollmentMarch 14, 2008
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ConditionsAcute hypertension in patients who present with intracerebral hemorrhageMedDRA version: 9.1Level: LLTClassification code 10022754Term: Intracerebral hemorrhageMedDRA version: 9.1Level: LLTClassification code 10020772Term: Hypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute hypertension in patients who present with intracerebral hemorrhage
Sponsor
The Medicines Company
Enrollment
60
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 14, 2008
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. CT evidence of intracerebral hemorrhage (diagnosis within 6 hours of symptom onset)
  • •2\. Age 18 years or older
  • •3\. Baseline systolic blood pressure (SBP) (immediately prior initiation of clevidipine) \> 160 mm Hg measured using an arterial line
  • •4\. Requires antihypertensive therapy to achieve SBP less than or equal to 160 mm HG
  • •5\. Written informed consent from the patient or their legal representative before initiation of any study\-related procedures
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •1\. Decision for early surgical evacuation (e.g. large cerebellar or lobar hemorrhage)
  • •2\. Receipt of an oral hypertensive within 2 hours prior to initiation of clevidipine
  • •3\. Treatment with a continuous infusion of an intravenous (IV) antihypertensive agent prior to initiation of clevidipine. Bolus treatment with labetalol or hydralazine is permitted
  • •4\. Intracerebral hematoma considered to be related to trauma by neurologist or neurosurgeon
  • •5\. Aneurysmal sub\-arachnoid hemorrhage
  • •6\. Glasgow coma score \< 5 and fixed dilated pupils
  • •7\. Expectation that the patient will not tolerate or require intravenous antihypertensive therapy for a minimum of 30 minutes
  • •8\. Coagulopathy (INR \>1\.3 at screening)
  • •9\. Known or suspected aortic dissection
  • •10\. Acute myocardial infarction (AMI)

Outcomes

Primary Outcomes

Not specified

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