Clinical trial NCT04116112: Blood Pressure After Endovascular Stroke Therapy-II
Official title: Blood Pressure After Endovascular Stroke Therapy-II: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Stroke
Endovascular Thrombectomy
Keywords: Blood Pressure Control
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Vanderbilt University Medical Center
First posted: 2019-10-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Final Infarct Volume
timeFrame: 36 (+/-12) hrs after treatment initiation
measure: Utility-weighted Modified Rankin Score
timeFrame: 90 days after treatment initiation
Secondary outcomes:
measure: Number of Participants With Any Hemorrhagic Transformation
timeFrame: 36(+/-12) hrs after treatment initiation
measure: Number of Participants With Symptomatic Hemorrhagic Transformation
timeFrame: 36(+/-12) hrs after treatment initiation
measure: Number of Participants With Neurological Worsening Associated With Antihypertensive Treatment
timeFrame: Treatment initiation to 24 hrs after treatment initiation
Other outcomes:
measure: Compliance Outcome
timeFrame: Treatment initiation to 24 hrs after treatment Initiation
Locations:
city: Hartford
country: United States
facility: Hartford Healthcare
state: Connecticut
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: University of Cincinnati
name: Eva Mistry, MBBS
role: PRINCIPAL_INVESTIGATOR
References: