Clevidipine for Blood Pressure Control After Stroke

(CLEVER Trial)

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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the idea that Clevidipine for Blood Pressure Control After Stroke is an effective drug?

The available research shows that Clevidipine is effective in quickly controlling high blood pressure in critical situations, such as after a stroke. One study compared Clevidipine to another drug, Nicardipine, and aimed to see which one controlled blood pressure faster in stroke patients. Clevidipine's rapid action and short duration allow for precise blood pressure management, which is crucial in preventing further complications. Additionally, Clevidipine has been shown to be effective in controlling blood pressure in other critical care settings, like during neurosurgery, which supports its effectiveness in managing acute hypertension. ^{1 2 3 4 5}

What safety data exists for Clevidipine in blood pressure control after stroke?

Clevidipine, an ultrashort-acting intravenous calcium channel blocker, has been evaluated in several clinical studies for its safety and efficacy in managing acute hypertension. It is approved by the FDA for blood pressure reduction when oral therapy is not feasible. Clinical trials, particularly Phase III, have shown it to be effective in lowering blood pressure with a relatively low occurrence of adverse events such as reflex tachycardia, atrial fibrillation, and acute renal failure. However, further investigation is needed to define its therapeutic role due to the lack of specific clinical outcomes documenting improved morbidity and mortality rates compared to other agents. Its safety profile includes minimal side effects, and it is considered promising for acute hypertension management in various clinical settings. ^{1 2 6 7 8}

Is clevidipine a promising drug for controlling blood pressure after a stroke?

Yes, clevidipine is a promising drug for controlling blood pressure after a stroke. It works quickly and precisely, making it effective in emergencies. It can be easily adjusted to maintain the right blood pressure, and it has been successful in various clinical settings. ^{1 4 5 8 9}

Research Team

Mouhammad Jumaa, MD

Principal Investigator

ProMedica Health System

Eligibility Criteria

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.

I am 18 years old or older.

Your blood pressure is very high during the procedure.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Role of clevidipine butyrate in the treatment of acute hypertension in the critical care setting: a review. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Clevidipine : a state-of-the-art antihypertensive drug under the scope. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of Clevidipine and Nicardipine for Acute Blood Pressure Reduction in Patients With Stroke. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Clevidipine for acute hypertension in patients with subarachnoid hemorrhage: a pilot study. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy of clevidipine in controlling perioperative hypertension in neurosurgical patients: initial single-center experience. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Clevidipine: a short-acting intravenous dihydropyridine calcium channel blocker for the management of hypertension. [2012]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of Nicardipine with Clevidipine in the Management of Hypertension in Acute Cerebrovascular Diseases. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Clevidipine butyrate: a promising new drug for the management of acute hypertension. [2019]

9. New Zealand pubmed.ncbi.nlm.nih.gov

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