Stroke, AcutePhase 3CLEVERNCT05175547
Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke
A Phase 3 study testing Clevidipine in people with Stroke, Acute and Blood Pressure, run by ProMedica Health System at 1 site in United States.
Trial summary
The CLEVER Study is a prospective, 2-arm, randomized, single-center pilot study to assess the safety and efficacy of intensive blood pressure control using Clevidipine (on-label use) in AIS patients undergoing standard of care mechanical thrombectomy (MT) within 24-hours of symptoms onset. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Blood Pressure, Mechanical Thrombectomy
- What is being tested?
- Clevidipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2021to 28 Feb 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- 1. Age 18 or older
- 2. Acute hypertension (systolic blood pressure of greater than 140 mmHg) at recanalization
- 3. Anterior circulation ischemic stroke symptoms and confirmed occlusion (ICA, M1, or M2) on angiogram with mechanical thrombectomy initiated within 24 hours since last known well
- 4. Success revascularization score of mTICI 2c or higher after mechanical thrombectomy
- 5. ASPECTS score of greater than 6
- 6. Premorbid mRS 0-4
- 7. Signed informed consent within 30 minutes from end of MT procedure.
Who cannot join
- 1. Presence of any hemorrhage and/or ASPECT score ≤6 on baseline head CT scan
- 2. Pregnant or lactating
- 3. Acute traumatic brain injury
- 4. Patient on active dialysis
- 5. Intracranial neoplasm
- 6. Acute or recent STEMI in the last 30 days
Show all 9Show fewer
- 7. Severe arrhythmias, unstable cardiac function
- 8. Any terminal medical condition with life expectancy less than 6 months
- 9. Concurrent enrollment in another trial that could confound the results of this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke (CLEVER)
The CLEVER Study is a prospective, 2-arm, randomized, single-center pilot study to assess the safety and efficacy of intensive blood pressure control using Clevidipine (on-label use) in AIS patients undergoing standard of care mechanical thrombectomy (MT) within 24-hours of symptoms onset.
Read the detailed description
The CLEVER Study is a prospective, 2-arm, randomized, single-center pilot study to assess the safety and efficacy of intensive blood pressure control using Clevidipine (on-label use) in AIS patients undergoing standard of care mechanical thrombectomy (MT) within 24-hours of symptoms onset. Eligible patients will be randomized 1:1 to a systolic blood pressure goal after successful MT (mTICI 2c or greater) of either: 90-120mmHg (Intensive BP management group) or 90-160mmHg (Standard BP management group). Patients enrolled into the study will be followed and assessed for up to 3 months.
- Conditions
- Stroke, Acute, Blood Pressure, Mechanical Thrombectomy
- Being tested
- Clevidipine
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClevidipineDrug
Blood pressure management with Clevidipine
| Study group | Role | What they receive |
|---|---|---|
| Intensive blood pressure management group | Active comparator | Target blood pressure of 90-120mmHg (Intensive BP management group) Receives: Drug: Clevidipine |
| Standard blood pressure management group | Active comparator | Target blood pressure of 90-160mmHg (Standard BP management group) Receives: Drug: Clevidipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint (Drug-related)
Time to target blood pressure
Measured: Time from drug initiation to target blood pressure, up to 24 hours after study drug adminstration
Primary Safety Endpoint (Disease-related)
Incidence of any hemorrhagic conversion at 24 hours
Measured: 24 hours from the time of treatment with Clevidipine
Secondary outcomes (11)
Drug-related
The efficacy of Clevidipine in maintaining BP within range using area under the curve (AUC) analysis of BP excursions beyond predetermined upper and lower limits using statistical models from the ECLIPSE Trials.
Measured: Up to 24 hours after study drug adminstration
Drug-related, Rate of hypotension requiring intervention
Rate of hypotension requiring intervention
Measured: Up to 24 hours after study drug adminstration
Drug-related, Rate of hypotension and severe hypertension
Rate of hypotension and severe hypertension
Measured: Up to 24 hours after study drug adminstration
Disease-related, Incidence of symptomatic intracerebral hemorrhage
Incidence of symptomatic intracerebral hemorrhage (sICH), defined as any intracranial hemorrhage and neurologic worsening of at least 4 points on the National Institute of Health Stroke Scale (NIHSS), according to the 2nd European-Australasian Acute Stroke Study (ECASS II) criteria within 24 hours of randomization
Measured: Within 24 hours of randomization
Disease-related, Delayed ICH after 24 hours
Delayed ICH after 24 hours
Measured: Within 24 hours of randomization
Disease-related, Incidence of acute kidney injury
Incidence of acute kidney injury
Measured: From drug adminstration to 90 days post-randomization
Disease-related,
Mortality rate at 90 days
Measured: 90 days after randomization
Disease-related, Length of hospital stay
Length of hospital stay
Measured: Day 6 (+/- 1 day) post-randomization or discharge (whichever sooner)
Disease-related, Use of additional hypertensive agents
Use of additional hypertensive agents
Measured: Up to 24 hours after study drug adminstration
Disease-related, Onset of atrial fibrillation or cardiovascular events
Onset of atrial fibrillation or cardiovascular events
Measured: Up to 24 hours after study drug adminstration
Disease-related, mRS 0-2 or return to baseline at 90 days
mRS 0-2 or return to baseline at 90 days
Measured: 90 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start30 Oct 2021
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be randomized 1:1 to a systolic blood pressure goal after successful MT (mTICI 2c or greater) of either: 90-120 or 90-160mmHg.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProMedica Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mouhammad Jumaa, MD, Principal investigator, ProMedica Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175547
- Sponsor's protocol ID
- CLEVER
- Acronym
- CLEVER
- Status last verified
- Jan 2025
- First submitted
- 23 Nov 2021
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke (CLEVER)
- ClinicalTrials.gov ID
- NCT05175547
- Acronym / sponsor ID
- CLEVER / CLEVER
- Conditions
- Stroke, Acute, Blood Pressure, Mechanical Thrombectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- ProMedica Health SystemUniversity, hospital or other
- Study start
- 30 Oct 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 3 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CLEVER Study is a prospective, 2-arm, randomized, single-center pilot study to assess the safety and efficacy of intensive blood pressure control using Clevidipine (on-label use) in AIS patients undergoing standard of care mechanical thrombectomy (MT) within 24-hours of symptoms onset.
Detailed description
The CLEVER Study is a prospective, 2-arm, randomized, single-center pilot study to assess the safety and efficacy of intensive blood pressure control using Clevidipine (on-label use) in AIS patients undergoing standard of care mechanical thrombectomy (MT) within 24-hours of symptoms onset. Eligible patients will be randomized 1:1 to a systolic blood pressure goal after successful MT (mTICI 2c or greater) of either: 90-120mmHg (Intensive BP management group) or 90-160mmHg (Standard BP management group). Patients enrolled into the study will be followed and assessed for up to 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible patients will be randomized 1:1 to a systolic blood pressure goal after successful MT (mTICI 2c or greater) of either: 90-120 or 90-160mmHg.
| Arm | Type | Receives |
|---|---|---|
| Intensive blood pressure management group | Active comparator | Drug: ClevidipineTarget blood pressure of 90-120mmHg (Intensive BP management group) |
| Standard blood pressure management group | Active comparator | Drug: ClevidipineTarget blood pressure of 90-160mmHg (Standard BP management group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Age 18 or older
- 2. Acute hypertension (systolic blood pressure of greater than 140 mmHg) at recanalization
- 3. Anterior circulation ischemic stroke symptoms and confirmed occlusion (ICA, M1, or M2) on angiogram with mechanical thrombectomy initiated within 24 hours since last known well
- 4. Success revascularization score of mTICI 2c or higher after mechanical thrombectomy
- 5. ASPECTS score of greater than 6
Key exclusion criteria (9 listed)
- 1. Presence of any hemorrhage and/or ASPECT score ≤6 on baseline head CT scan
- 2. Pregnant or lactating
- 3. Acute traumatic brain injury
- 4. Patient on active dialysis
- 5. Intracranial neoplasm
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 |
|---|---|---|
| ClevidipineBlood pressure management with Clevidipine | Drug | Intensive blood pressure management group, Standard blood pressure management group |
Primary outcome
Primary Efficacy Endpoint (Drug-related)
Time frame: Time from drug initiation to target blood pressure, up to 24 hours after study drug adminstration
Time to target blood pressure
Primary Safety Endpoint (Disease-related)
Time frame: 24 hours from the time of treatment with Clevidipine
Incidence of any hemorrhagic conversion at 24 hours
11 secondary outcomes
Drug-related
Time frame: Up to 24 hours after study drug adminstration
Drug-related, Rate of hypotension requiring intervention
Time frame: Up to 24 hours after study drug adminstration
Drug-related, Rate of hypotension and severe hypertension
Time frame: Up to 24 hours after study drug adminstration
Disease-related, Incidence of symptomatic intracerebral hemorrhage
Time frame: Within 24 hours of randomization
Disease-related, Delayed ICH after 24 hours
Time frame: Within 24 hours of randomization
Disease-related, Incidence of acute kidney injury
Time frame: From drug adminstration to 90 days post-randomization
Disease-related,
Time frame: 90 days after randomization
Disease-related, Length of hospital stay
Time frame: Day 6 (+/- 1 day) post-randomization or discharge (whichever sooner)
Disease-related, Use of additional hypertensive agents
Time frame: Up to 24 hours after study drug adminstration
Disease-related, Onset of atrial fibrillation or cardiovascular events
Time frame: Up to 24 hours after study drug adminstration
Disease-related, mRS 0-2 or return to baseline at 90 days
Time frame: 90 days post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Mouhammad Jumaa, MD principal investigator
ProMedica Health System
1 site in 1 country: 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 Stroke, Acute and Blood Pressure, run by ProMedica 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 7 inclusion and 9 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 7 Jan 2025. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Efficacy Endpoint (Drug-related) (time frame: Time from drug initiation to target blood pressure, up to 24 hours after study drug adminstration). The study lists 2 primary outcomes in all. 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 7 Jan 2025.