Phase 3 N=35 Treatment

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

Hypertension · Hemorrhage

Bottom Line

View on ClinicalTrials.gov: NCT00666328 ↗

Enrolled (actual)

Serious AEs

25.7%

Results posted

Apr 2013

Primary outcome: Primary: Median Time to Achieve Target SBP Range (≤160 mmHg to ≥140 mmHg) Within 30 Minutes of Initiation of Clevidipine — 5.5 minutes

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: clevidipine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Medicines Company
Primary completion: Apr 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Median Time to Achieve Target SBP Range (≤160 mmHg to ≥140 mmHg) Within 30 Minutes of Initiation of Clevidipine	5.5	—
SECONDARY Percentage of Participants Achieving a SBP of ≤160 mmHg Within 30 Minutes of Initiation of Clevidipine	97	—
SECONDARY Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion	-2.2; -4.7; -5.9; -8.5; -9.8; -11.3	—
SECONDARY Magnitude, Frequency and Duration of Systolic Blood Pressure Excursions (Calculated as Area Under the Curve [AUC]) Outside the Target Range Normalized Per Hour for the Duration of the Clevidipine Monotherapy Infusion	347.7	—
SECONDARY Percent Time Blood Pressures Were Maintained Within the Target Range (Systolic Blood Pressure ≤160 mmHg to ≥140 mmHg) Over Each 24 Hour Period During Monotherapy Infusion of Clevidipine	51.91; 61.12; 46.94; 65.91	—
SECONDARY Mean Dose of Clevidipine During the Treatment Period	260.28	—
SECONDARY Median Dose of Clevidipine During the Treatment Period	116.32	—
SECONDARY Proportion of Patients Requiring an Additional or Alternative Antihypertensive Agent(s) With or Without Clevidipine	18	—
SECONDARY Percent Change in Heart Rate During 30 of Initiation of Clevidipine	-0.4; -0.7; -0.3; 0.2; 2.1; 2.6	—
SECONDARY The Percentage of Patients Whose Systolic Blood Pressure is <90 mmHg Within 30 Minutes of the Initiation of Clevidipine Infusion	—	—

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).

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00666328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.