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

NCT04205305 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2025-03-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

conventional blood pressure control (labetalol, nicardipine)

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

DRUG

intensive blood pressure control (labetalol, nicardipine)

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-18
Primary Completion
2023-07-23
Completion
2023-07-23

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04205305 on ClinicalTrials.gov