HypertensionPhase 3ACCELERATENCT00666328
Clevidipine in the Treatment of Patients With Acute Hypertension and Intracerebral Hemorrhage (ACCELERATE)
A Phase 3 study testing clevidipine in people with Hypertension and Hemorrhage, run by The Medicines Company at 17 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Hemorrhage
- What is being tested?
- clevidipine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Jun 2008to Apr 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States14 sites
The John Hopkins Hospital
Baltimore, Maryland, 21287
Medical University of South Carolina
Charleston, South Carolina, 29425
Cleveland Clinic Hospitals
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43210
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Guilford Neurologic - Moses H Cone Health System
Greensboro, North Carolina, 27405
The Queens Medical Center
Honolulu, Hawaii, 96813
Intermountain Medical Center
Murray, Utah, 84157
Columbia University Medical Center
New York, New York, 10032
Thomas Jefferson University Stroke Research
Philadelphia, Pennsylvania, 19107
Maine Medical Center
Portland, Massachusetts, 04102
The University Health Science Center at S.A.
San Antonio, Texas, 78229-3900
Washington Hospital Center
Washington D.C., District of Columbia, 20010-2975
Germany3 sites
Universitatsklinikum Erlangen
Erlangen, D91054
Universitatsklinikum Heidelberg
Heidelberg, D69120
Universitätsklinikum Leipzig
Liebigstraße 22a, Leipzig, D-04103
About this study
Official title: The Evaluation of Patients With Acute Hypertension and Intracerebral Hemorrhage With Intravenous Clevidipine Treatment (ACCELERATE)
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).
Read the 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 control acute hypertension in patients with intracerebral hemorrhage. Informed consent was obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures. At screening, a clinical and neurological examination was carried out. For the purposes of this study, acute hypertension was defined as SBP >160 mmHg immediately prior to initiation of study drug. Approximately 30 to 40 patients with acute intracerebral hemorrhage (ICH) were planned to be enrolled with approximately 10 patients requiring monitoring of intracranial pressure (ICP). Infusion of study drug was initiated within 12 hours of ICH symptom onset. All eligible patients enrolled received clevidipine in an open label manner. Clevidipine was to be infused at an initial rate of 2.0 mg/h for the first 1.5 minutes. Thereafter, titration to higher infusion rates were to be attempted as needed, to obtain the target SBP range (SBP ≤160 mmHg to ≥140 mmHg). Titration to effect was to proceed by doubling the dose every 1.5 minutes, up to a maximum of 32.0 mg/h, until the desired effect (SBP within the target range) was attained. During the first 30 minutes, if the desired blood pressure lowering effect was not attained or maintained, an alternative intravenous (IV) antihypertensive agent(s), advised to be a different class other than calcium channel blockers, could be used with or without stopping the clevidipine infusion. The clevidipine infusion could continue for up to a maximum of 96 hours. Twenty-four hour follow-up computerized tomography (CT) scan results were recorded, including measurement of intracerebral hematoma volumes. Assessment of safety was performed throughout the treatment period and until 6 hours after termination of study drug. Patients were followed for 7 days following termination of the clevidipine infusion.
- Conditions
- Hypertension, Hemorrhage
- Being tested
- clevidipine
- Keywords
- Hypertension, Hemorrhage, Intracranial Pressure, Antihypertensive Agent, Calcium Channel Blocker
- Medical subject headings
- Hypertension, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clevidipineDrug
Also called clevidipine injectable emulsion, clevidipine emulsion, Cleviprex
Clevidipine injectable emulsion (0.5 mg/mL) in 20% lipid emulsion in 100 mL bottles was administered intravenously to all patients via a single dedicated line.
Clevidipine was infused at an initial rate of 2.0 mg/h for the first 1.5 minutes. Thereafter, titration to higher infusion rates were to be attempted as needed to obtain the target systolic blood pressure (SBP) range (SBP ≤160 mmHg to ≥140 mmHg). Titration to effect was to proceed by doubling the dose every 1.5 minutes, up to a maximum of 32.0 mg/h, until the desired effect (SBP within the target range) was attained. The clevidipine infusion rate could be increased or decreased to maintain systolic blood pressure for up to a maximum of 96 hours.
| Study group | Role | What they receive |
|---|---|---|
| clevidipine | Experimental | This will be a single-arm study with no reference therapy. Receives: Drug: clevidipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Time to Achieve Target SBP Range (≤160 mmHg to ≥140 mmHg) Within 30 Minutes of Initiation of Clevidipine
The median time, in minutes, was estimated with its two-tailed 95% confidence interval from the time of the initiation of clevidipine infusion until the first observed SBP was achieved in the target range of ≤160 mmHg to ≥140 mmHg within the first 30 minutes of clevidipine treatment. If patients did not reach the blood pressure target range within the first 30 minutes, their data was considered censored at 30 minutes. If another IV and/or oral antihypertensive agent indicated for hypertension was administered less than 30 minutes prior to achieving the endpoint, the data was considered censored at the time when the additional or alternative antihypertensive agent was given.
Measured: Within 30 minutes of study drug initiation
Secondary outcomes (9)
Percentage of Participants Achieving a SBP of ≤160 mmHg Within 30 Minutes of Initiation of Clevidipine
The percentage of patients who reached SBP of ≤160 mmHg within the first 30 minutes of initiation of clevidipine infusion was summarized. If an additional or alternative IV antihypertensive agent and/or oral antihypertensive agent was administered for hypertension prior to a patient achieving SBP≤160 mmHg during the initial 30-minute treatment period, then the patient was considered to have failed to reach this efficacy endpoint.
Measured: Within 30 minutes of study drug initiation
Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion
Over the initial 30 minutes of the treatment period, the percent change from baseline (defined as immediately prior to study drug initiation) was summarized descriptively at 1, 2, 3, 4, 5, 6, 7, 10, 15, 20, 25, and 30 minutes after clevidipine initiation. Decreases in SBP from baseline were observed over the course of this time period.
Measured: Baseline through 30 minutes post initiation of clevidipine infusion
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
Total AUC-SBP captures the magnitude and duration of SBP either above the upper limit of the target SBP range at 160 mm Hg or below the lower limit of 140 mm Hg and normalized per hour for the duration of clevidipine infusion. A larger value for AUC-SBP indicates greater SBP variability outside the target range.
Measured: Duration of the study drug infusion (up to 96 hours)
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
The percent time that SBP was maintained within the SBP target range (≤160 mmHg to ≥140 mmHg) was summarized for each 24-hour period of monotherapy of clevidipine infusion through 96 hours (0 -≤24 h, 24-≤48 h, 48-≤72 h, 72-≤96 h). For purposes of this analysis, SBP data were available from all mITT patients for the overall infusion period and from 0 to ≤24 hours of infusion; however, data was only available for 8 patients from 24 to ≤48 hours, 4 patients from 48 to ≤72 hours and 1 patient from 72 to ≤96 hours due to the variability in infusion durations >24 hours across patients.
Measured: From study drug initiation through termination (up to 96 h)
Mean Dose of Clevidipine During the Treatment Period
Mean total dose of clevidipine from study drug initiation to the end of clevidipine treatment
Measured: Up to 96 hours
Median Dose of Clevidipine During the Treatment Period
Mean total dose of clevidipine from study drug initiation to the end of clevidipine treatment
Measured: Up to 96 hours
Proportion of Patients Requiring an Additional or Alternative Antihypertensive Agent(s) With or Without Clevidipine
Additional or alternative antihypertensive agent(s) comprise the use of other antihypertensive agent(s) either with clevidipine (additional) or in place of clevidipine (alternative) for the indication of hypertension from the time of clevidipine initiation to clevidipine termination. For purposes of this analysis, additional or alternative antihypertensive agents did not include oral antihypertensives that were administered in order to transition IV clevidipine-treated patients to oral therapy during the transition period of the study.
Measured: Up to 96 hours
Percent Change in Heart Rate During 30 of Initiation of Clevidipine
Multiple timepoints were assessed (minutes 1, 2, 3, 4, 5, 10, 15, 20, 30) for analysis of percent change in heart rate during the initial 30 minutes.
Measured: From study drug initiation through each specified timepoint
The Percentage of Patients Whose Systolic Blood Pressure is <90 mmHg Within 30 Minutes of the Initiation of Clevidipine Infusion
Measured: Within 30 minutes of the initiation of study drug infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Medicines Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carmelo Graffagnino, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666328
- Sponsor's protocol ID
- TMC-CLV-07-02
- Acronym
- ACCELERATE
- Status last verified
- Aug 2014
- First submitted
- 22 Apr 2008
- Last updated
- 29 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Patients With Acute Hypertension and Intracerebral Hemorrhage With Intravenous Clevidipine Treatment (ACCELERATE)
- ClinicalTrials.gov ID
- NCT00666328
- Acronym / sponsor ID
- ACCELERATE / TMC-CLV-07-02
- Conditions
- Hypertension, Hemorrhage
- Keywords
- Hypertension, Hemorrhage, Intracranial Pressure, Antihypertensive Agent, Calcium Channel Blocker
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 24 Apr 2008 (estimated)
- Results
- Posted 8 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 control acute hypertension in patients with intracerebral hemorrhage. Informed consent was obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures. At screening, a clinical and neurological examination was carried out. For the purposes of this study, acute hypertension was defined as SBP >160 mmHg immediately prior to initiation of study drug. Approximately 30 to 40 patients with acute intracerebral hemorrhage (ICH) were planned to be enrolled with approximately 10 patients requiring monitoring of intracranial pressure (ICP). Infusion of study drug was initiated within 12 hours of ICH symptom onset. All eligible patients enrolled received clevidipine in an open label manner. Clevidipine was to be infused at an initial rate of 2.0 mg/h for the first 1.5 minutes. Thereafter, titration to higher infusion rates were to be attempted as needed, to obtain the target SBP range (SBP ≤160 mmHg to ≥140 mmHg). Titration to effect was to proceed by doubling the dose every 1.5 minutes, up to a maximum of 32.0 mg/h, until the desired effect (SBP within the target range) was attained. During the first 30 minutes, if the desired blood pressure lowering effect was not attained or maintained, an alternative intravenous (IV) antihypertensive agent(s), advised to be a different class other than calcium channel blockers, could be used with or without stopping the clevidipine infusion. The clevidipine infusion could continue for up to a maximum of 96 hours. Twenty-four hour follow-up computerized tomography (CT) scan results were recorded, including measurement of intracerebral hematoma volumes. Assessment of safety was performed throughout the treatment period and until 6 hours after termination of study drug. Patients were followed for 7 days following termination of the clevidipine infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clevidipine | Experimental | Drug: clevidipineThis will be a single-arm study with no reference therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clevidipineAlso: clevidipine injectable emulsion, clevidipine emulsion, CleviprexClevidipine injectable emulsion (0.5 mg/mL) in 20% lipid emulsion in 100 mL bottles was administered intravenously to all patients via a single dedicated line. Clevidipine was infused at an initial rate of 2.0 mg/h for the first 1.5 minutes. Thereafter, titration to higher infusion rates were to be attempted as needed to obtain the target systolic blood pressure (SBP) range (SBP ≤160 mmHg to ≥140 mmHg). Titration to effect was to proceed by doubling the dose every 1.5 minutes, up to a maximum of 32.0 mg/h, until the desired effect (SBP within the target range) was attained. The clevidipine infusion rate could be increased or decreased to maintain systolic blood pressure for up to a maximum of 96 hours. | Drug | clevidipine |
Primary outcome
Median Time to Achieve Target SBP Range (≤160 mmHg to ≥140 mmHg) Within 30 Minutes of Initiation of Clevidipine
Time frame: Within 30 minutes of study drug initiation
The median time, in minutes, was estimated with its two-tailed 95% confidence interval from the time of the initiation of clevidipine infusion until the first observed SBP was achieved in the target range of ≤160 mmHg to ≥140 mmHg within the first 30 minutes of clevidipine treatment. If patients did not reach the blood pressure target range within the first 30 minutes, their data was considered censored at 30 minutes. If another IV and/or oral antihypertensive agent indicated for hypertension was administered less than 30 minutes prior to achieving the endpoint, the data was considered censored at the time when the additional or alternative antihypertensive agent was given.
9 secondary outcomes
Percentage of Participants Achieving a SBP of ≤160 mmHg Within 30 Minutes of Initiation of Clevidipine
Time frame: Within 30 minutes of study drug initiation
Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion
Time frame: Baseline through 30 minutes post initiation of clevidipine infusion
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
Time frame: Duration of the study drug infusion (up to 96 hours)
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
Time frame: From study drug initiation through termination (up to 96 h)
Mean Dose of Clevidipine During the Treatment Period
Time frame: Up to 96 hours
Median Dose of Clevidipine During the Treatment Period
Time frame: Up to 96 hours
Proportion of Patients Requiring an Additional or Alternative Antihypertensive Agent(s) With or Without Clevidipine
Time frame: Up to 96 hours
Percent Change in Heart Rate During 30 of Initiation of Clevidipine
Time frame: From study drug initiation through each specified timepoint
The Percentage of Patients Whose Systolic Blood Pressure is <90 mmHg Within 30 Minutes of the Initiation of Clevidipine Infusion
Time frame: Within 30 minutes of the initiation of study drug infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmelo Graffagnino, MD principal investigator
Duke University
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing clevidipine in people with Hypertension and Hemorrhage, run by The Medicines Company at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Time to Achieve Target SBP Range (≤160 mmHg to ≥140 mmHg) Within 30 Minutes of Initiation of Clevidipine (time frame: Within 30 minutes of study drug initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2014.