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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive blood pressure management group | Active Comparator | Target blood pressure of 90-120mmHg (Intensive BP management group) |
|
| Standard blood pressure management group | Active Comparator | Target blood pressure of 90-160mmHg (Standard BP management group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clevidipine | Drug | Blood pressure management with Clevidipine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint (Drug-related) | Time to target blood pressure | 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 | 24 hours from the time of treatment with Clevidipine |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 hours after study drug adminstration |
| Drug-related, Rate of hypotension requiring intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mouhammad Jumaa, MD | ProMedica Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProMedica Toledo Hospital | Toledo | Ohio | 43606 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C118563 | clevidipine |
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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.
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Rate of hypotension requiring intervention |
| Up to 24 hours after study drug adminstration |
| Drug-related, Rate of hypotension and severe hypertension | Rate of hypotension and severe hypertension | 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 | Within 24 hours of randomization |
| Disease-related, Delayed ICH after 24 hours | Delayed ICH after 24 hours | Within 24 hours of randomization |
| Disease-related, Incidence of acute kidney injury | Incidence of acute kidney injury | From drug adminstration to 90 days post-randomization |
| Disease-related, | Mortality rate at 90 days | 90 days after randomization |
| Disease-related, Length of hospital stay | Length of hospital stay | Day 6 (+/- 1 day) post-randomization or discharge (whichever sooner) |
| Disease-related, Use of additional hypertensive agents | Use of additional hypertensive agents | Up to 24 hours after study drug adminstration |
| Disease-related, Onset of atrial fibrillation or cardiovascular events | Onset of atrial fibrillation or cardiovascular events | 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 | 90 days post-randomization |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |