CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 120 enrolled
Drug / intervention
Nicardipine +2 moredrug
Likely dose
Nicardipine 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04116112
NCT04116112Phase 2Completed

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

University of Cincinnati·interventional·Posted Oct 4, 2019·Updated Oct 12, 2023

In Brief

A Phase 2 clinical trial evaluating Nicardipine, Labetalol, and 1 other intervention for Acute Stroke and Endovascular Thrombectomy. Completed, enrolled 120 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedOct 4, 2019
Enrollment StartJan 17, 2020
Primary CompletionJul 1, 2022
Study CompletionDec 15, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.7 years ago

Interventions

Nicardipinedrug

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.

Labetaloldrug

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

Hydralazinedrug

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.