Blood Pressure After Endovascular Stroke Therapy-II

Blood Pressure After Endovascular Stroke Therapy-II: A Randomized Trial

Sponsors

Lead Sponsor: Vanderbilt University Medical Center

Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)

Source Vanderbilt University Medical Center
Brief Summary

The purpose of this study is to assess the safety of lowering blood pressure in acute stroke patients that are successfully treated with a mechanical thrombectomy procedure. The investogators will evaluate the hypothesis that lower blood pressure management strategies do not result in larger volume of stroke or worse 3-month clinical outcome in these patients.

Detailed Description

Several thousand patients suffer from an ischemic stroke caused by an occlusion of a large blood vessel supplying the brain. Endovascular mechanical thrombectomy (EVT) has revolutionized management of this most devastating type of ischemic stroke by allowing removal of the occlusive clot. However, about half of the successfully EVT-treated patients (~85% of all treated patients) still remain disabled at 90 days. Early evidence suggests that patients with lower blood pressure (BP) after the thrombectomy procedure have better outcomes. However, safety of lowering BP in these patients has not been determined. The primary safety concern of lowering BP comes from the potential of compromising blood flow to the "at risk" area of the brain following the stroke. The purpose of this trial is to evaluate the safety of lower BP management strategies in patients who are successfully treated with endovascular treatment for ischemic stroke. The investigator will enroll 120 individuals who qualify and randomly assign them to one of the three systolic BP (SBP) targets: ≤180 mmHg, <160 mmHg, and <140 mmHg (40 patients in each group). Treatment will begin soon after the blood clot causing the stroke is removed, using anti-hypertensive medication given intravenously with a goal to lower and maintain the SBP below assigned target for 24 hrs. The scientists will assess the safety of lower BP targets (<160 mmHg and <140 mmHg) by quantifying the volume of stroke measured with an MRI scan obtained at 36+/-12 hours and participants' functional status at 90 days measured with a patient centered disability score. Participants will undergo the 36 +/-12-hour MRI scan as part of their routine clinical care and will not be asked to prolong their hospital stay for study purpose. A phone interview will take place to determine their functional status at 90-days. Enrollment of 120 patients will provide 80% power to detect a 10 cubic centimeter increase in stroke volume and a 0.10 decrease in utility-weighted modified Rankin score (a patient-centered disability score) for every 20 mmHg decrease in SBP. An interim analysis will be conducted after enrollment of 60 patients at which time the study may stop for safety concerns.

Overall Status Recruiting
Start Date 2020-01-17
Completion Date 2023-03-30
Primary Completion Date 2023-03-30
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Final Infarct Volume 36 (+/-12) hrs after treatment initiation
Utility-weighted modified Rankin Score 90 days after treatment initiation
Secondary Outcome
Measure Time Frame
Number of participants with any hemorrhagic transformation 36(+/-12) hrs after treatment initiation
Number of participants with symptomatic hemorrhagic transformation 36(+/-12) hrs after treatment initiation
Number of participants with neurological worsening associated with antihypertensive treatment Treatment initiation to 24 hrs after treatment initiation
Enrollment 120
Condition
Intervention

Intervention Type: Drug

Intervention Name: Nicardipine

Description: In the event where SBP values are above the randomly assigned target, intravenous nicardipine will be initiated at 2.5 mg/hr to lower the SBP. If SBP is still not reduced to below assigned target after 15 minutes, nicardipine dose will be increased by 2.5 mg/hr every 15 minutes until the target SBP or a maximum dose of 15 mg/hr is reached.

Other Name: Cardene

Intervention Type: Drug

Intervention Name: Labetalol

Description: If SBP is above target despite maximum nicardipine infusion for 30 minutes, 10-20 mg of intravenous labetalol will be added every 15 minutes.

Intervention Type: Drug

Intervention Name: Hydralazine

Description: If SBP remains unresponsive for 1 hr despite the use of maximum doses of nicardipine and labetalol, a Hydralazine will be added at the treating physician's discretion. Incidence of the latter scenario is anticipated to be exceedingly rare.

Other Name: Apresoline

Eligibility

Criteria:

Inclusion Criteria: - Adult patients (≥18 years) - Undergoing successful EVT (defined as modified Thrombolysis in Cerebral Ischemia Score, mTICI, ≥2b) for an occlusion in the anterior cerebral circulation large vessel (internal carotid artery and M1 or M2 segments of the middle cerebral artery). - Intervention will be initiated only for those with a successful recanalization (modified Thrombolysis in Cerebral Ischemia Score ≥ 2b). - Undergoing a baseline CT or MR perfusion study - Those with unsuccessful recanalization (mTICI 0-2a) will be not intervened upon. Exclusion Criteria: - Known heart failure with ejection fraction <30% - Presence of a left ventricular assist device - Patients undergoing extracorporeal membrane oxygenation - Pregnancy - Enrollment in any other clinical trial

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Eva Mistry, MBBS Principal Investigator Vanderbilt University Medical Center
Overall Contact

Last Name: Eva Mistry, MBBS

Phone: 615936006

Email: [email protected]

Location
Facility: Status: Contact:
University of Cincinnati | Cincinnati, Ohio, 45221, United States Recruiting Hilary Perez
Vanderbilt Univeristy Medical Center | Nashville, Tennessee, 37212, United States Recruiting Eva Mistry, MBBS 615-936-0060 [email protected]
Location Countries

United States

Verification Date

2020-07-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Vanderbilt University Medical Center

Investigator Full Name: Eva Mistry

Investigator Title: Assistant Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Higher Systolic Blood Pressure (SBP) Target

Type: Experimental

Description: Lower systolic blood pressure to ≤180 mmHg and maintain for 24 hours. If anti-hypertensive medication used, then maintain ≥160 mmHg.

Label: Lower SBP (<160 mmHg) Target

Type: Experimental

Description: Lower systolic blood pressure to <160 mmHg and maintain for 24 hours. If anti-hypertensive medication used, then maintain >140 mmHg.

Label: Lower SBP (<140mmHg) Target

Type: Experimental

Description: Lower systolic blood pressure to <140 mmHg and maintain for 24 hours. If anti-hypertensive medication used, then maintain >110 mmHg.

Acronym BEST-II
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov

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