NCT04205305

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

June 18, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2023

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

3.1 years

First QC Date

November 21, 2019

Last Update Submit

March 16, 2025

Conditions

Ischemic Stroke

Keywords

Acute ischemic strokeblood pressurehypertensionendovascular thrombectomyrecanalization

Outcome Measures

Primary Outcomes (3)

  • Modified Rankin scale scores(mRS)

    Effectiveness outcome: Functional independence (modified Rankin score 0 to 2) -The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire.

    90 days

  • symptomatic intracerebral hemorrhage: Number of participants with symptomatic intracerebral hemorrhage

    Safety outcome: The definition in the European Cooperative Acute Stroke Study III (ECASS 3) will be adopted : a large local or remote parenchymal pattern (\>30% of the infarcted area affected by hemorrhage, with mass effect or extension outside the infarct), intraventricular hemorrhage, or subarachnoid hemorrhage which is identified as the predominant cause of the neurologic deterioration from baseline (increase of ≥4 points in the NIHSS score) or death within 36 hours.

    36 hours

  • Death related to the index stroke within 90 days

    90 days

Secondary Outcomes (12)

  • BP parameters - systolic blood pressure

    24 hour

  • BP parameters - diastolic blood pressure

    24 hour

  • BP parameters - blood pressure variability

    24 hour

  • Functional independence

    1 month

  • Distribution of the modified Rankin scores (shift analysis)

    90 days

  • +7 more secondary outcomes

Study Arms (2)

Conventional blood pressure control group

ACTIVE COMPARATOR

systolic blood pressure \<180 mmHg

Drug: conventional blood pressure control (labetalol, nicardipine)

Intensive blood pressure control group

EXPERIMENTAL

systolic blood pressure \<140 mmHg

Drug: intensive blood pressure control (labetalol, nicardipine)

Interventions

conventional blood pressure control (labetalol, nicardipine)DRUG

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

Conventional blood pressure control group
intensive blood pressure control (labetalol, nicardipine)DRUG

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

Intensive blood pressure control group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥20 years
  • Acute ischemic stroke patients who underwent intraarterial treatment for large vessel occlusion. (ICA, MCA M1 or M2, ACA A1, PCA P1)
  • Patients with successful recanalization after intraarterial thrombectomy (TICI 2b or TICI 3) 4. Patients with elevated BP (systolic BP ≥140 mmHg) on at least two measurements with a two-minute interval within 2 hours of successful recanalization.

You may not qualify if:

  • Age \<20
  • Patients with contraindication for use antihypertensive medication after intraarterial thrombectomy.
  • Patients with blood pressure \<140 mmHg after successful recanalization.
  • Patients with symptomatic intracranial hemorrhage after successful recanalization
  • Patients with pre-morbid neurological dysfunction (modified Rankin Scale, mRS \>2)
  • Patients with severe medical and surgical diseases.
  • Patients who are considered having a difficulty to enrollment.
  • No informed consents from patients.
  • Patients who participated in a study that did not allow duplicate participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (5)

  • Jung JW, Kim YD, Heo J, Lee H, Kim BM, Kim DJ, Shin NY, Joo H, Cho BH, Ahn SH, Park H, Sohn SI, Hong JH, Yun J, Song TJ, Chang Y, Kim GS, Seo KD, Lee K, Chang JY, Seo JH, Lee S, Baek JH, Cho HJ, Shin DH, Kim J, Yoo J, Baik M, Jung YH, Hwang YH, Kim CK, Kim JG, Lee IH, Choi JK, Lee CJ, Park S, Jeon S, Lee HS, Kim KH, Kwon SU, Bang OY, Heo JH, Nam HS; OPTIMAL-BP Trial Investigators. Association Between Intravenous Antihypertensives and Functional Outcome After Successful Endovascular Thrombectomy. Stroke. 2025 Sep;56(9):2503-2515. doi: 10.1161/STROKEAHA.125.051696. Epub 2025 Jul 3.

    PMID: 40605757DERIVED

  • Jung JW, Kim KH, Yun J, Joo H, Kim YD, Heo J, Lee H, Kim BM, Kim DJ, Shin NY, Cho BH, Ahn SH, Park H, Sohn SI, Hong JH, Song TJ, Chang Y, Kim GS, Seo KD, Lee K, Chang JY, Seo JH, Lee S, Baek JH, Cho HJ, Shin DH, Kim J, Yoo J, Baik M, Jung YH, Hwang YH, Kim CK, Kim JG, Lee IH, Choi JK, Lee CJ, Park S, Jeon S, Lee HS, Kwon SU, Bang OY, Heo JH, Nam HS. Blood pressure management based on infarct volume after successful endovascular thrombectomy. Eur Stroke J. 2025 Dec;10(4):1281-1291. doi: 10.1177/23969873251335204. Epub 2025 May 2.

    PMID: 40317165DERIVED

  • Yun J, Kim KH, Jung JW, Kim YD, Heo J, Lee H, Choi JK, Lim IH, Hong SH, Kim BM, Kim DJ, Shin NY, Cho BH, Ahn SH, Park H, Sohn SI, Hong JH, Song TJ, Chang Y, Kim GS, Seo KD, Lee K, Chang JY, Seo JH, Lee S, Baek JH, Cho HJ, Shin DH, Kim J, Yoo J, Baik M, Lee KY, Jung YH, Hwang YH, Kim CK, Kim JG, Lee CJ, Park S, Jeon S, Lee HS, Kwon SU, Lee IH, Bang OY, Heo JH, Nam HS. Effects of blood pressure lowering in patients treated with intravenous thrombolysis before endovascular thrombectomy. Int J Stroke. 2025 Jul;20(6):696-707. doi: 10.1177/17474930251315630. Epub 2025 Feb 6.

    PMID: 39819210DERIVED

  • Nam HS, Kim YD, Heo J, Lee H, Jung JW, Choi JK, Lee IH, Lim IH, Hong SH, Baik M, Kim BM, Kim DJ, Shin NY, Cho BH, Ahn SH, Park H, Sohn SI, Hong JH, Song TJ, Chang Y, Kim GS, Seo KD, Lee K, Chang JY, Seo JH, Lee S, Baek JH, Cho HJ, Shin DH, Kim J, Yoo J, Lee KY, Jung YH, Hwang YH, Kim CK, Kim JG, Lee CJ, Park S, Lee HS, Kwon SU, Bang OY, Anderson CS, Heo JH; OPTIMAL-BP Trial Investigators. Intensive vs Conventional Blood Pressure Lowering After Endovascular Thrombectomy in Acute Ischemic Stroke: The OPTIMAL-BP Randomized Clinical Trial. JAMA. 2023 Sep 5;330(9):832-842. doi: 10.1001/jama.2023.14590.

    PMID: 37668619DERIVED

  • Nam HS, Kim YD, Choi JK, Baik M, Kim BM, Kim DJ, Heo J, Shin DH, Lee KY, Jung YH, Baek JH, Hwang YH, Sohn SI, Hong JH, Park H, Kim CK, Kim GS, Seo KD, Lee K, Seo JH, Bang OY, Seo WK, Chung JW, Chang JY, Kwon SU, Lee J, Kim J, Yoo J, Song TJ, Ahn SH, Cho BH, Cho HJ, Kim JG, Chang Y, Lee CJ, Park S, Park G, Lee HS. Outcome in Patients Treated with Intra-arterial thrombectomy: The optiMAL Blood Pressure control (OPTIMAL-BP) Trial. Int J Stroke. 2022 Oct;17(8):931 - 937. doi: 10.1177/17474930211041213. Epub 2021 Aug 24.

    PMID: 34427481DERIVED

Related Links

MeSH Terms

Conditions

Ischemic StrokeHypertension

Interventions

LabetalolNicardipine

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsSalicylamidesAmidesAminesDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Three months after discharge, the independence assessment will be performed by the researcher who don't know the patients group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1. The study is a multicenter, prospective, randomized, open-label trial with blinded end-point assessment (PROBE) design study. 2. After successful revascularization, the active blood pressure control group and the standard blood pressure control group will be randomized by 1: 1. 3. Patients who have undergone intraarterial thrombectomy due to acute cerebral infarction and have successfully reopened arteries will be enrolled. 4. Medical history, laboratory findings and blood pressure parameters (systolic blood pressure, diastolic blood pressure, blood pressure variability, etc.), neurological scores, functional recovery, and quality of life indicators will be collected. 5. Neurological scores, functional recovery scores, and quality of life indicators are performed by independent researchers in the blind state. 6. All data is collected using e-CRF, and the image study will be anonymized and sent to the central adjudication.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2019

First Posted

December 19, 2019

Study Start

June 18, 2020

Primary Completion

July 23, 2023

Study Completion

July 23, 2023

Last Updated

March 19, 2025

Record last verified: 2025-03

Locations

KR(1)