Blood Pressure After Endovascular Stroke Therapy-II

NCT04116112 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 191520K23NS113858
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Stroke; Endovascular Thrombectomy

Keywords

Blood Pressure Control

Outcome Measures

Primary Outcomes (2)

• Final Infarct Volume

  Infarct volume on diffusion-weighted MRI (or CT if MRI cannot be obtained) at 36 (+/-12) hrs after treatment initiation, adjusted for the baseline CT perfusion core infract volume.

  36 (+/-12) hrs after treatment initiation

• Utility-weighted Modified Rankin Score

  Modified Rankin score (mRS) is a scale for measuring the degree of disability or dependence of people who have suffered a stroke. 0 - no symptoms at all; 1 - no significant disability despite symptoms; able to carry out all usual duties and activities; 2- slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- moderate disability; requiring some help, but able to walk without assistance; 4 - moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5 - severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- dead. Patient centered utility weights are applied to these scores as 1.0 for mRS level 0; 0.91 for mRS level 1; 0.76 for mRS level 2; 0.65 for mRS level 3; 0.33 for mRS level 4; 0 for mRS level 5; and 0 for mRS level 6. Unlike the mRS, the utility-weighted mRS runs from 0 to 1, with 0 being the worst.

  90 days after treatment initiation

Secondary Outcomes (3)

• 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

Other Outcomes (1)

• Compliance Outcome

  Treatment initiation to 24 hrs after treatment Initiation

Study Arms (3)

Higher Systolic Blood Pressure (SBP) Target

EXPERIMENTAL

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

Drug: Nicardipine; Drug: Labetalol; Drug: Hydralazine

Lower SBP (<160 mmHg) Target

EXPERIMENTAL

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

Drug: Nicardipine; Drug: Labetalol; Drug: Hydralazine

Lower SBP (<140mmHg) Target

EXPERIMENTAL

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

Drug: Nicardipine; Drug: Labetalol; Drug: Hydralazine

Interventions

Nicardipine DRUG

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.

Also known as: Cardene

Higher Systolic Blood Pressure (SBP) Target; Lower SBP (<140mmHg) Target; Lower SBP (<160 mmHg) Target

Labetalol DRUG

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

Higher Systolic Blood Pressure (SBP) Target; Lower SBP (<140mmHg) Target; Lower SBP (<160 mmHg) Target

Hydralazine DRUG

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.

Also known as: Apresoline

Higher Systolic Blood Pressure (SBP) Target; Lower SBP (<140mmHg) Target; Lower SBP (<160 mmHg) Target

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Vanderbilt University Medical Center: collaborator

Study Sites (3)

Hartford Healthcare

Hartford, Connecticut, 06103, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (2)

• Mistry EA, Hart K, Davis T, Yeatts S, Lindsell CJ, Lewis RJ, Albers G, Wanderer JP, Prestigiacomo C, Bernard GR, Khatri P. Design of the BEST-II Randomized Clinical Trial. Stroke Vasc Interv Neurol. 2022 May 5;2(3):e000249. doi: 10.1161/SVIN.121.000249. eCollection 2022 May.

  PMID: 41583626 DERIVED

• Mistry EA, Hart KW, Davis LT, Gao Y, Prestigiacomo CJ, Mittal S, Mehta T, LaFever H, Harker P, Wilson-Perez HE, Beasley KA, Krothapalli N, Lippincott E, Stefek H, Froehler M, Chitale R, Fusco M, Grossman A, Shirani P, Smith M, Jaffa MN, Yeatts SD, Albers GW, Wanderer JP, Tolles J, Lindsell CJ, Lewis RJ, Bernard GR, Khatri P. Blood Pressure Management After Endovascular Therapy for Acute Ischemic Stroke: The BEST-II Randomized Clinical Trial. JAMA. 2023 Sep 5;330(9):821-831. doi: 10.1001/jama.2023.14330.

  PMID: 37668620 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Nicardipine; Labetalol; Hydralazine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines; Phthalazines; Pyridazines

Limitations and Caveats

Participants enrolled at only three sites across the US

Results Point of Contact

• Title: Dr. Eva A. Mistry
• Organization: University of Cincinnati

mistryea@ucmail.uc.edu

513-558-1291

Study Officials

• Eva Mistry, MBBS

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 4, 2019
• Study Start: January 17, 2020
• Primary Completion: July 1, 2022
• Study Completion: December 15, 2022
• Last Updated: October 12, 2023
• Results First Posted: October 12, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

US (3)