Subarachnoid HemorrhagePhase 2CLASHNCT00978822
Safety and Efficacy Study of Clevidipine to Control Hypertension in Patients Admitted With Aneurysmal Subarachnoid Hemorrhage
A Phase 2 study testing Clevidipine butyrate injectable emulsion in people with Subarachnoid Hemorrhage and Hypertension, run by Henry Ford Health System at 1 site in United States.
Trial summary
This study is designed to assess how rapidly and how safely Clevidipine can be used to control high Blood Pressure in patients with subarachnoid hemorrhage which is a type of brain bleed that happens because of a weak balloon like structure in one of the brain vessels. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Hypertension
- What is being tested?
- Clevidipine butyrate injectable emulsion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Dec 2012
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of SAH
- Presence of unsecured aneurysm
- Patient age between 18 and 80 years
- Hunt and Hess grade <5 (non-sedated-paralyzed pt)
- Glasgow Coma scale >4 (non-sedated-paralyzed pt)
- BP above the pre-specified upper limit set by MD
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- Patient has not received pressors or inotropes
- Patient has not received IV anti-hypertensives for more than 5 minutes (sodium nitroprusside infusion should be stopped as clevidipine is started
- Patient has given informed consent
Who cannot join
- Patient is <18 or >80 years of age
- Patient has Traumatic SAH
- Patient has Perimesencephalic SAH
- Hunt and Hess grade 5 (deeply comatose/ brain dead)
- Glasgow Coma scale 3 or 4 (deeply comatose/brain dead)
- Patient on pressors or anti-hypertensives for more than 5 minutes
Show all 15Show fewer
- SBP < 90 mm Hg
- Heart rate >110
- Patient with Left BBB
- Patient with a permanent ventricular pacemaker
- Known allergy to dihydropyridines or clevidipine
- Known allergy to soy products, beans, eggs or egg products22. Patients with defective lipid metabolism or pathologic hyperlipidemia or lipid nephrosis
- Acute pancreatitis, accompanied by hyperlipidemia
- Severe aortic stenosis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clevidipine in Aneurysmal Subarachnoid Hemorrhage, A Pilot Study
This study is designed to assess how rapidly and how safely Clevidipine can be used to control high Blood Pressure in patients with subarachnoid hemorrhage which is a type of brain bleed that happens because of a weak balloon like structure in one of the brain vessels. Control of blood pressure is of high value in preventing this balloon that ruptured and bled from rebleeding. The ultimate cure would be to shut down the aneurysm by a surgical procedure. Clevidipine is a drug that can lower blood pressure and it is given through the vein as a continuous infusion. It is a very short acting drug which is important in controlling labile blood pressure condition with rapid changes between up and down. This trial will test for its rapid actions and check for any side effects and possibly any other potential benefit.
Read the detailed description
This is a single center, 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 aneurysmal subarachnoid hemorrhage. At screening a clinical and neurological examination will be carried out. For the purposes of this study, acute hypertension will be defined as a range of SBP to be controlled within immediately prior to initiation of study drug. Approximately 20 patients with acute A SAH will be enrolled. Infusion of study drug will be initiated as soon ass the patient arrives in the ER and diagnosis is made and consent is obtained. All eligible patients will be enrolled to receive clevidipine in an open label manner.
Clevidipine will be infused at an initial rate of 2.0 mg/h for the first 90 seconds. Thereafter, titration to higher infusion rates can be attempted as needed q90 seconds to obtain the target SBP range.
Titration to effect is to proceed by doubling the dose every 90 seconds, up to a maximum of 32.0 mg/h, until the desired effect (SBP within the target range) is attained. Clevidipine infusion may continue for up to a maximum of 48 hours. Blood pressure and ICP recording will be recorded q 5 minutes. Assessment of safety will be performed throughout the treatment period and until 6 hours after termination of study drug.
- Conditions
- Subarachnoid Hemorrhage, Hypertension
- Being tested
- Clevidipine butyrate injectable emulsion
- Keywords
- Subarachnoid hemorrhage, Hypertension, brain Aneurysm, intracerebral hemorrhage, antihypertensive, calcium channel blockers, infusion, neurocritical care
- Medical subject headings
- Subarachnoid Hemorrhage, Hypertension, Intracranial Aneurysm, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clevidipine butyrate injectable emulsionDrug
Also called Cleviprex
Clevidipine butyrate injectable emulsion infusion starting at 2 mg/hour and titrating up for effect till 32 mg/h for up to 24 hours starting in the emergency department and continued in the critical care units.
| Study group | Role | What they receive |
|---|---|---|
| Clevidipine butyrate injectable emulsion | Experimental | Not described Receives: Drug: Clevidipine butyrate injectable emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to Control and Maintain Blood Pressure Within a Certain Range by the Drug Infusion.
All patients reached the SBP target after initiation of the first infusion within 14.2 ± 6.4 min (n = 5, range 7-22 min)
Study closed October 2012
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2012
- Study completionDec 2012
Why it stopped: Difficult enrollment parameters, subsequently low enrollment. Decision to terminate trial.
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 Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- The Medicines Company
- Responsible party
- Principal investigator, Panayiotis Varelas, Henry Ford Health System
- Investigators
- Panayiotis N Varelas, MD PhD, Principal investigator, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978822
- Sponsor's protocol ID
- CLV-0904-001
- Other IDs
- PCF Varelas 5605
- Acronym
- CLASH
- Status last verified
- Feb 2023
- First submitted
- 16 Sep 2009
- Last updated
- 2 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clevidipine in Aneurysmal Subarachnoid Hemorrhage, A Pilot Study
- ClinicalTrials.gov ID
- NCT00978822
- Acronym / sponsor ID
- CLASH / CLV-0904-001
- Conditions
- Subarachnoid Hemorrhage, Hypertension
- Keywords
- Subarachnoid hemorrhage, Hypertension, brain Aneurysm, intracerebral hemorrhage, antihypertensive, calcium channel blockers, infusion, neurocritical care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult enrollment parameters, subsequently low enrollment. Decision to terminate trial.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- The Medicines Company
- Study start
- Jun 2009 (actual)
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Sep 2009 (estimated)
- Results
- Posted 28 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess how rapidly and how safely Clevidipine can be used to control high Blood Pressure in patients with subarachnoid hemorrhage which is a type of brain bleed that happens because of a weak balloon like structure in one of the brain vessels. Control of blood pressure is of high value in preventing this balloon that ruptured and bled from rebleeding. The ultimate cure would be to shut down the aneurysm by a surgical procedure. Clevidipine is a drug that can lower blood pressure and it is given through the vein as a continuous infusion. It is a very short acting drug which is important in controlling labile blood pressure condition with rapid changes between up and down. This trial will test for its rapid actions and check for any side effects and possibly any other potential benefit.
Detailed description
This is a single center, 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 aneurysmal subarachnoid hemorrhage. At screening a clinical and neurological examination will be carried out. For the purposes of this study, acute hypertension will be defined as a range of SBP to be controlled within immediately prior to initiation of study drug. Approximately 20 patients with acute A SAH will be enrolled. Infusion of study drug will be initiated as soon ass the patient arrives in the ER and diagnosis is made and consent is obtained. All eligible patients will be enrolled to receive clevidipine in an open label manner.
Clevidipine will be infused at an initial rate of 2.0 mg/h for the first 90 seconds. Thereafter, titration to higher infusion rates can be attempted as needed q90 seconds to obtain the target SBP range.
Titration to effect is to proceed by doubling the dose every 90 seconds, up to a maximum of 32.0 mg/h, until the desired effect (SBP within the target range) is attained. Clevidipine infusion may continue for up to a maximum of 48 hours. Blood pressure and ICP recording will be recorded q 5 minutes. Assessment of safety will be performed throughout the treatment period and until 6 hours after termination of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clevidipine butyrate injectable emulsion | Experimental | Drug: Clevidipine butyrate injectable emulsion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of SAH
- Presence of unsecured aneurysm
- Patient age between 18 and 80 years
- Hunt and Hess grade <5 (non-sedated-paralyzed pt)
- Glasgow Coma scale >4 (non-sedated-paralyzed pt)
Key exclusion criteria (15 listed)
- Patient is <18 or >80 years of age
- Patient has Traumatic SAH
- Patient has Perimesencephalic SAH
- Hunt and Hess grade 5 (deeply comatose/ brain dead)
- Glasgow Coma scale 3 or 4 (deeply comatose/brain dead)
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 |
|---|---|---|
| Clevidipine butyrate injectable emulsionAlso: CleviprexClevidipine butyrate injectable emulsion infusion starting at 2 mg/hour and titrating up for effect till 32 mg/h for up to 24 hours starting in the emergency department and continued in the critical care units. | Drug | Clevidipine butyrate injectable emulsion |
Primary outcome
Ability to Control and Maintain Blood Pressure Within a Certain Range by the Drug Infusion.
Time frame: 30 minutes
All patients reached the SBP target after initiation of the first infusion within 14.2 ± 6.4 min (n = 5, range 7-22 min) Study closed October 2012
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- 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.
Panayiotis N Varelas, MD PhD principal investigator
Henry Ford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clevidipine butyrate injectable emulsion in people with Subarachnoid Hemorrhage and Hypertension, run by Henry Ford Health System at 1 site in United States.
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 9 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: stopped early, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 28 Feb 2023). 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?
Ability to Control and Maintain Blood Pressure Within a Certain Range by the Drug Infusion. (time frame: 30 minutes). 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 2 Mar 2023.