Blood Pressure After Endovascular Stroke Therapy-II

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
University of Cincinnati
Study ID
NCT04116112
Phase
PHASE2
Status
Completed

Conditions

  • Acute Stroke
  • Endovascular Thrombectomy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Jan 17, 2020
Status verified
Sep 2023
Primary completion
Jul 1, 2022
Completion
Dec 15, 2022

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Higher Systolic Blood Pressure (SBP) Target
    Lower systolic blood pressure to ≤180 mmHg and maintain for 24 hours. If anti-hypertensive medication used, then maintain ≥160 mmHg.
  • Experimental: Lower SBP (<160 mmHg) Target
    Lower systolic blood pressure to \<160 mmHg and maintain for 24 hours. If anti-hypertensive medication used, then maintain \>140 mmHg.
  • Experimental: Lower SBP (<140mmHg) Target
    Lower systolic blood pressure to \<140 mmHg and maintain for 24 hours. If anti-hypertensive medication used, then maintain \>110 mmHg.

Primary Outcome Measure

Final Infarct Volume [ Time Frame: 36 (+/-12) hrs after treatment initiation ]

Locations (3)

FacilityCityStateZIPSite coordinators
Hartford HealthcareHartfordConnecticut06103-
University of CincinnatiCincinnatiOhio45221-
Vanderbilt University Medical CenterNashvilleTennessee37203-

Find similar trials in Hartford, CT

By research site
Hartford Healthcare· Hartford, CTUniversity of Cincinnati· Cincinnati, OHVanderbilt University Medical Center· Nashville, TN

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