CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 306 enrolled
Drug / intervention
conventional blood pressure control (labetalol, nicardipine) +1 moredrug
Likely dose
Not stated in 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/NCT04205305
NCT04205305Phase 4Completed

Outcome in Patients Treated with Intraarterial Thrombectomy - OptiMAL Blood Pressure Control (OPTIMAL-BP)

Yonsei University·interventional·Posted Dec 19, 2019·Updated Mar 19, 2025

In Brief

A Phase 4 clinical trial evaluating conventional blood pressure control (labetalol, nicardipine) and intensive blood pressure control (labetalol, nicardipine) for Ischemic Stroke. Completed, enrolled 306 participants across 1 site.

Detailed Summary

Recent endovascular thrombectomy (EVT) trial have proven the effectiveness of intraarterial revascularization in patients with larger cerebral artery occlusion. The success rate of EVT is close to 80%, but only 50% of patients improve to independent functional outcome. Therefore, new treatment strategies are needed to reduce the futile revascularization. However, updated guidelines recommend the indications for EVT based on the results of randomized clinical trials (RCT), management of post-revascularization is largely unknown. Current guidelines suggest that systolic blood pressure should be adjusted below 180 mmHg and diastolic blood pressure below 105 mmHg in patients undergoing intraarterial reopening. However, in the case of successful recanalization by EVT, same guideline is adopted even though the possibility of intracerebral hemorrhage or reperfusion injury by high blood pressure. On the other hand, too low blood pressure can worsen cerebral ischemia. Therefore, this study will compare the effectiveness of active blood pressure control group (with less than 140 mmHg systolic blood pressure) versus standard blood pressure control group (with less than 180 mmHg systolic blood pressure) during the first 24 hours in patients who underwent EVT and achieved successful recanalization (TICI 2b-3). The goal is to reach the target blood pressure within 60 minutes of randomization.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIschemic Stroke
CountriesSouth Korea
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedDec 19, 2019
Enrollment StartJun 18, 2020
Primary CompletionJul 23, 2023
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 6.5 years ago

Interventions

conventional blood pressure control (labetalol, nicardipine)drug

After successful recanalization, appropriate antihypertension medication is administered to control systolic blood pressure \<180 mmHg.

intensive blood pressure control (labetalol, nicardipine)drug

After successful recanalization, appropriate antihypertension medication is administered to control systolic blood pressure \<140 mmHg.