Clevidipine for Blood Pressure Control After Stroke

(CLEVER Trial)

No longer recruiting at 1 trial location

Overseen By Mouhammad Jumaa, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: ProMedica Health System

Disqualifiers: Hemorrhage, Pregnancy, Dialysis, STEMI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Clevidipine, a medication used to lower blood pressure, to determine its safety and effectiveness in controlling blood pressure in stroke patients undergoing mechanical thrombectomy. The study compares two groups: one with standard blood pressure targets and another with more intensive targets. It seeks participants who have experienced a specific type of stroke and high blood pressure after the procedure. Individuals who have had a stroke affecting the front part of the brain and underwent a procedure to remove a blockage within the last 24 hours may qualify. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it is important to discuss your current medications with the trial team to ensure they do not interfere with the study.

Is there any evidence suggesting that Clevidipine is likely to be safe for humans?

Research has shown that Clevidipine is a safe and effective treatment for high blood pressure. It quickly lowers blood pressure and maintains control over an extended period. Studies have found that it works well without causing serious side effects. For instance, one study found that Clevidipine helped people reach their blood pressure goals faster than Nicardipine, with no major safety differences between them. Another study confirmed that Clevidipine is as safe as other drugs used during surgeries. These findings suggest Clevidipine is well-tolerated, making it a reliable choice for controlling blood pressure in various situations. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Clevidipine is unique because it offers a fast-acting approach to managing blood pressure specifically after a stroke. Unlike traditional medications like beta-blockers or ACE inhibitors, Clevidipine is administered intravenously, allowing for rapid adjustment and control of blood pressure levels. Researchers are excited about Clevidipine because it targets calcium channels, which may lead to more precise control without the delays associated with oral medications. This rapid response is crucial in the critical period following a stroke, where managing blood pressure effectively can significantly impact recovery outcomes.

What evidence suggests that Clevidipine is effective for blood pressure control after stroke?

Research has shown that Clevidipine effectively lowers high blood pressure quickly. It reduces the systolic blood pressure in over 90% of patients within just 30 minutes. One study found that it can maintain blood pressure control for up to 18 hours. Compared to nicardipine, Clevidipine reaches blood pressure goals faster. This trial will compare Clevidipine's effectiveness in two blood pressure management strategies: the standard management group and the intensive management group. This makes Clevidipine a strong option for managing blood pressure in patients after a stroke. ^{1 3 4 6 7}

Who Is on the Research Team?

Mouhammad Jumaa, MD

Principal Investigator

ProMedica Health System

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had a successful mechanical thrombectomy for an ischemic stroke in the brain's anterior circulation within the last day. They must have high blood pressure after the procedure, a decent chance of recovery, and give consent quickly post-procedure. Pregnant women, those with recent severe heart issues or brain injuries, terminal conditions, or hemorrhages on their CT scans can't join.

Inclusion Criteria

I signed the consent form within 30 minutes after the MT procedure.

Your blood pressure is very high during the procedure.

I had a stroke with a blocked artery in my brain and received a clot removal procedure within 24 hours.

Exclusion Criteria

I have a brain tumor.

Concurrent enrollment in another trial that could confound the results of this study

I had a severe heart attack in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Clevidipine infusion for blood pressure management after successful mechanical thrombectomy

24 hours

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Clevidipine

Trial Overview The CLEVER Study is testing how safe and effective Clevidipine is at controlling high blood pressure in patients who've just undergone a mechanical thrombectomy to treat an acute ischemic stroke. Participants are randomly assigned to receive this medication as part of standard care.

How Is the Trial Designed?

Group I: Standard blood pressure management group Active Control 1 Intervention

Target blood pressure of 90-160mmHg (Standard BP management group)

Group II: Intensive blood pressure management group Active Control 1 Intervention

Target blood pressure of 90-120mmHg (Intensive BP management group)

Who Is Running the Clinical Trial?

ProMedica Health System

Lead Sponsor

Trials

14

Recruited

760+

Published Research Related to This Trial

Clevidipine butyrate is an ultrashort-acting intravenous calcium channel blocker that effectively lowers blood pressure in critical care settings, helping to prevent acute end-organ damage and perioperative complications.

With a half-life of about 1 minute, clevidipine allows for precise blood pressure control, enabling healthcare providers to make quick adjustments that are not possible with other intravenous medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of clevidipine butyrate in the treatment of acute hypertension in the critical care setting: a review. Awad, AS., Goldberg, ME.[2021]

Clevidipine butyrate is an FDA-approved intravenous calcium-channel blocker that effectively and rapidly reduces blood pressure in hypertensive emergencies, making it suitable for acute management when oral medications are not feasible.

It has unique properties that allow for precise blood pressure control with minimal side effects, and it can be easily administered and transitioned to oral therapy, demonstrating its potential as a valuable treatment option in various clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clevidipine butyrate: a promising new drug for the management of acute hypertension. Bergese, SD., Puente, EG.[2019]

In a pilot study involving five patients with aneurysmal subarachnoid hemorrhage, clevidipine effectively controlled elevated blood pressure, achieving target systolic blood pressure (SBP) within an average of 14.2 minutes.

Clevidipine maintained SBP within the desired range 70% of the time during infusion, demonstrating its efficacy and safety, as no patients experienced re-bleeding or major complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clevidipine for acute hypertension in patients with subarachnoid hemorrhage: a pilot study. Varelas, PN., Abdelhak, T., Corry, JJ., et al.[2014]

Intravenous clevidipine effectively manages blood pressure in perioperative and intensive care settings, showing superior efficacy compared to nitroglycerin and sodium nitroprusside in cardiac surgery patients, based on results from the ESCAPE-1 and ESCAPE-2 trials.

Clevidipine is generally well tolerated, with minimal side effects such as reflex tachycardia, making it a safe option for rapid blood pressure control, especially in patients with acute neurological injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clevidipine: a review of its use for managing blood pressure in perioperative and intensive care settings. Keating, GM.[2021]

Clevidipine is an effective injectable medication for rapidly lowering blood pressure, particularly useful in situations where oral medications are not suitable, as demonstrated in phase III trials focused on cardiac surgery and acute severe hypertension.

While clevidipine has a relatively low incidence of adverse events, concerns remain regarding its lipid formulation and the need for further studies to clarify its impact on long-term health outcomes compared to other blood pressure medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clevidipine: a short-acting intravenous dihydropyridine calcium channel blocker for the management of hypertension. Erickson, AL., DeGrado, JR., Fanikos, JR.[2012]

In a study comparing nicardipine and clevidipine for managing hypertension in acute stroke patients, both medications were found to be equally effective, with similar times to reach target blood pressure and no significant differences in overall efficacy outcomes.

The study suggests that while both drugs are safe and effective, factors like cost and volume restrictions may influence the choice of treatment in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Nicardipine with Clevidipine in the Management of Hypertension in Acute Cerebrovascular Diseases. Rosenfeldt, Z., Conklen, K., Jones, B., et al.[2018]

In a study of 210 patients with acute ischemic stroke or intracerebral hemorrhage, clevidipine and nicardipine achieved similar times to reach target blood pressure, with clevidipine taking an average of 50 minutes and nicardipine 74 minutes, showing no significant difference (P = .101).

Clevidipine was associated with a lower incidence of hypotension (7.1%) compared to nicardipine (10%), indicating a potentially safer profile in terms of blood pressure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Clevidipine and Nicardipine for Acute Blood Pressure Reduction in Patients With Stroke. Allison, TA., Bowman, S., Gulbis, B., et al.[2022]

Clevidipine butyrate is a newly approved intravenous antihypertensive that effectively lowers systolic blood pressure in over 90% of patients within 30 minutes, making it a promising option for managing severe acute hypertension.

This medication has a unique profile as it is arterially selective, has an ultrashort half-life, and does not interact with other medications, resulting in a low incidence of adverse reactions and good tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clevidipine : a state-of-the-art antihypertensive drug under the scope. Espina, IM., Varon, J.[2018]

In a study of 22 neurosurgical patients, clevidipine effectively controlled perioperative hypertension, achieving target blood pressure levels in 78.6% of hypertensive episodes within 15 minutes.

Clevidipine was found to be safe, with only two mild hypotensive episodes that resolved quickly, indicating its rapid action and manageable side effects in the neurosurgical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of clevidipine in controlling perioperative hypertension in neurosurgical patients: initial single-center experience. Bekker, A., Didehvar, S., Kim, S., et al.[2015]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0303846723000604

Comparison between clevidipine and nicardipine in ... We found that clevidipine reaches the SBP goal faster than nicardipine; however, there was no statistically significant difference between the two drugs.

2. cleviprex.com cleviprex.com/efficacy/

Efficacy | CLEVIPREX® (clevidipine) 92.5% of patients on CLEVIPREX achieved treatment success ... The primary endpoint was the incidence of treatment failure, defined as the inability to decrease ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2922306/

Role of clevidipine butyrate in the treatment of acute ... Clevidipine has been shown to be a safe and effective medication for rapidly reducing severely increased BP and controlling BP for 18 hours or longer.

4. withpower.com withpower.com/trial/clevidipine-for-blood-pressure-control-after-stroke-03a91

Clevidipine for Blood Pressure Control After Stroke Clevidipine butyrate is a newly approved intravenous antihypertensive that effectively lowers systolic blood pressure in over 90% of patients within 30 minutes, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05922436

a Study Evaluating the Safety and Efficacy of Clevidipine ... This is a multicenter, randomized, double-blind, active-compared Phase III clinical study to evaluate the efficacy and safety of clevidipine butyrate ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00978822?term=AREA%5BInterventionSearch%5D(CLEVIDIPINE%20BUTYRATE)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=6

NCT00978822 | Safety and Efficacy Study of Clevidipine to ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3172065/

Intravenous clevidipine for management of hypertension - PMC The study concluded that clevidipine was as safe as the other three drugs for use in the perioperative setting.