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NCT Number: NCT05175547

Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke

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.

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Key information

Conditions

Stroke, Acute Blood Pressure Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Mechanical Thrombectomy Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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

Treatment and study plan

clevidipine

Drug

Blood pressure management with Clevidipine

Primary outcomes

  1. 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

  2. Primary Safety Endpoint (Disease-related)

    Time frame: 24 hours from the time of treatment with Clevidipine

    Incidence of any hemorrhagic conversion at 24 hours

Secondary outcomes

  1. Drug-related

    Time frame: Up to 24 hours after study drug adminstration

    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.

  2. Drug-related, Rate of hypotension requiring intervention

    Time frame: Up to 24 hours after study drug adminstration

    Rate of hypotension requiring intervention

  3. Drug-related, Rate of hypotension and severe hypertension

    Time frame: Up to 24 hours after study drug adminstration

    Rate of hypotension and severe hypertension

  4. Disease-related, Incidence of symptomatic intracerebral hemorrhage

    Time frame: Within 24 hours of randomization

    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

  5. Disease-related, Delayed ICH after 24 hours

    Time frame: Within 24 hours of randomization

    Delayed ICH after 24 hours

  6. Disease-related, Incidence of acute kidney injury

    Time frame: From drug adminstration to 90 days post-randomization

    Incidence of acute kidney injury

  7. Disease-related,

    Time frame: 90 days after randomization

    Mortality rate at 90 days

  8. Disease-related, Length of hospital stay

    Time frame: Day 6 (+/- 1 day) post-randomization or discharge (whichever sooner)

    Length of hospital stay

  9. Disease-related, Use of additional hypertensive agents

    Time frame: Up to 24 hours after study drug adminstration

    Use of additional hypertensive agents

  10. Disease-related, Onset of atrial fibrillation or cardiovascular events

    Time frame: Up to 24 hours after study drug adminstration

    Onset of atrial fibrillation or cardiovascular events

  11. Disease-related, mRS 0-2 or return to baseline at 90 days

    Time frame: 90 days post-randomization

    mRS 0-2 or return to baseline at 90 days

Sponsors and collaborators

Lead sponsor

ProMedica Health System

Other

Registry information

Official study title

Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke (CLEVER)

Acronym: CLEVER

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 3, 2022
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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