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

• Conditions: Acute hypertension in patients who present with intracerebral hemorrhage; MedDRA version: 9.1Level: LLTClassification code 10022754Term: Intracerebral hemorrhage; MedDRA version: 9.1Level: LLTClassification code 10020772Term: Hypertension

• Registration Number: EUCTR2008-000230-53-DE
• Lead Sponsor: The Medicines Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-14
• Last Update Posted: 3 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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
F.1.3.1 Number of subjects for this age range

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)
11. Positive pregnancy test or known pregnancy
12. Intolerance or allergy to calcium channel blockers
13. Allergy to soybean oil or egg lecithin
14. Known liver failure, cirrhosis or pancreatitis
15. Prior directives against advanced life support
16. Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified