Blood Pressure, Mechanical Thrombectomy, Stroke, Acute
Conditions
Brief 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.
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.
Interventions
DRUGClevidipine
Blood pressure management with Clevidipine
Sponsors
ProMedica Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint (Drug-related) | 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) | 24 hours from the time of treatment with Clevidipine | Incidence of any hemorrhagic conversion at 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug-related, Rate of hypotension and severe hypertension | Up to 24 hours after study drug adminstration | Rate of hypotension and severe hypertension |
| Disease-related, Incidence of symptomatic intracerebral hemorrhage | 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 |
| Disease-related, Delayed ICH after 24 hours | Within 24 hours of randomization | Delayed ICH after 24 hours |
| Disease-related, Incidence of acute kidney injury | From drug adminstration to 90 days post-randomization | Incidence of acute kidney injury |
| Drug-related | 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. |
| Disease-related, Length of hospital stay | Day 6 (+/- 1 day) post-randomization or discharge (whichever sooner) | Length of hospital stay |
| Disease-related, Use of additional hypertensive agents | Up to 24 hours after study drug adminstration | Use of additional hypertensive agents |
| Disease-related, Onset of atrial fibrillation or cardiovascular events | Up to 24 hours after study drug adminstration | Onset of atrial fibrillation or cardiovascular events |
| Disease-related, mRS 0-2 or return to baseline at 90 days | 90 days post-randomization | mRS 0-2 or return to baseline at 90 days |
| Disease-related, | 90 days after randomization | Mortality rate at 90 days |
| Drug-related, Rate of hypotension requiring intervention | Up to 24 hours after study drug adminstration | Rate of hypotension requiring intervention |
Countries
United States
Outcome results
None listed