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Ischemic StrokePhase 4NCT04205305

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

A Phase 4 study of Ischemic Stroke, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Ischemic Stroke
Could I receive a placebo?
No, everyone receives an active treatment
How many people
306 participants
Where
1 siteSouth Korea
Study dates
18 Jun 2020to 23 Jul 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Department of Neurology, Yonsei University College of Medicine

    Seoul, Seoul, 120-752

Other trials in South Korea

About this study

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.

Read the detailed description
  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 is admitted to the Department of Neurology at the participating hospital with acute cerebral infarction will will be included for 5 years from December 2019 to December 2023 (based on the date of stroke). Patients who have undergone intraarterial thrombectomy and have successfully reopened arteries should be enrolled.
  4. Collect 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.
  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.
  7. Central adjudication will review the image study.
  8. One intermediate analysis will be conducted at the end of first period or when a half of study patients were enrolled.
Conditions
Ischemic Stroke
Being tested
conventional blood pressure control (labetalol, nicardipine), intensive blood pressure control (labetalol, nicardipine)
Keywords
Acute ischemic stroke, blood pressure, hypertension, endovascular thrombectomy, recanalization
Medical subject headings
Ischemic Stroke, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04205305
Study groupRoleWhat they receive
Conventional blood pressure control groupActive comparatorsystolic blood pressure <180 mmHg
Receives: Drug: conventional blood pressure control (labetalol, nicardipine)
Intensive blood pressure control groupExperimentalsystolic blood pressure <140 mmHg
Receives: Drug: intensive blood pressure control (labetalol, nicardipine)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 90 days

  2. 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.

    Measured: 36 hours

  3. Death related to the index stroke within 90 days

    Measured: 90 days

Secondary outcomes (12)

  1. BP parameters - systolic blood pressure

    change in systolic blood pressure

    Measured: 24 hour

  2. BP parameters - diastolic blood pressure

    change in diastolic blood pressure

    Measured: 24 hour

  3. BP parameters - blood pressure variability

    change in blood pressure variability

    Measured: 24 hour

  4. Functional independence

    modified Rankin score 0 to 2

    Measured: 1 month

  5. Distribution of the modified Rankin scores (shift analysis)

    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.

    Measured: 90 days

  6. National Institutes of Health Stroke Scale(NIHSS) score

    The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.

    Measured: 24 hour

  7. Excellent recovery

    NIHSS 0 -1 or improvement more than 8. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.

    Measured: 24 hour

  8. Recanalization status on CT Angiography(CTA) or MR Angiography(MRA)

    occurence of TICI 2b or 3 recanalization on CTA or MRA

    • The thrombolysis in cerebral infarction(TICI) scale is a tool for determining the response of thrombolytic therapy for ischemic stroke. The original description 1 was based on the angiographic appearances of the treated occluded vessel and the distal branches(Grade 0: no perfusion, Grade 1: penetration with minimal perfusion, Grade 2: partial perfusion, Grade 2A: only partial filling(less than two-thirds) of the entire vascular territory is visualized, Grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal, Grade 3: complete perfusion)

    Measured: 24±12 hour

  9. Quality of life measured by Euro-QoL

    EuroQol-5D (EQ-5D) is an instrument for measuring quality of life. The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health.

    Measured: 90 days

  10. Number of participants with malignant brain edema

    1. acute, complete MCA(middle cerebral artery) infarction with early parenchymal hypodensity of at least 50% of the MCA territory and signs of local brain swelling such as sulcal effacement and compression of the lateral ventricle; 2) midline shift of >5 mm at the septum pellucidum or pineal gland with obliteration of the basal cisterns; and 3) neurological deterioration consisting of a NIHSS increase by >2 points and decrease in the level of consciousness to a score of ≥ 1 on item 1A of the NIHSS.

    Measured: 24 hour

  11. Number of participants with treatment failure

    failure to achieve goal blood pressure(BP) for 2 consecutive BP measurements during the first 24 hours following EVT(endovascular thrombectomy)

    Measured: 24 hour

  12. CT or MRI ASPECTS(Alberta Stroke Program Early CT Score)

    Alberta Stroke Program Early CT Score(ASPECTS) is a 10-point quantitative score used to assess early ischemic changes on non-contrast CT head.

    To compute the ASPECTS, 1 point is subtracted from 10 for any evidence of early ischemic change for each of the defined regions. Identifying patients with a greater likelihood of poor functional outcome (scores <8) may be helpful in the early stages of care for supporting transfer or therapy decisions.

    Measured: 36 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2019
  2. Study start18 Jun 2020
  3. Primary completion23 Jul 2023
  4. Study completion23 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
306 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04205305
Sponsor's protocol ID
4-2019-1208
Status last verified
Mar 2025
First submitted
21 Nov 2019
Last updated
19 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: This is not a drug comparison study. Therefore IPD will not be shared.

Publications

  • Jung JW, Koh HB, Kim YD, Heo J, Lee H, Kim BM, Kim DJ, Shin NY, Yu S, Ahn SH, Sohn SI, Hong JH, Song TJ, Chang Y, Kim GS, Ok T, Chang JY, Seo JH, Lee S, Baek JH, Cho HJ, Yun J, Shin DH, Ha SH, Kim J, Yoo J, Baik M, Jung YH, Seo KD, Hwang YH, Park H, Kim CK, Kim JG, Lee IH, Choi JK, Jeon S, Lee HS, Kim KH, Kwon SU, Bang OY, Heo JH, Nam HS; OPTIMAL-BP trial investigators. Acute Kidney Injury After Intensive Blood Pressure Lowering Following Successful Endovascular Thrombectomy. Stroke. 2026 Jul 24. doi: 10.1161/STROKEAHA.126.056127. Online ahead of print.

    PubMed 42495732

  • Jung JW, Kim YD, Heo J, Lee H, Kim B, 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, Chang JY, Seo JH, Lee S, Baek JH, Cho HJ, Shin DH, Kim J, Yoo J, Baik M, Jung YH, Seo KD, Hwang YH, Kim CK, Kim JG, Lee IH, Choi JK, Jeon S, Lee HS, Kim KH, Kwon SU, Bang OY, Heo JH, Nam HS. Association of intensive blood pressure lowering after endovascular thrombectomy with outcomes according to contrast staining ASPECTS. Stroke Vasc Neurol. 2026 Jul 15:svn-2026-005132. doi: 10.1136/svn-2026-005132. Online ahead of print.

    PubMed 42457247

  • Jung JW, Kim YD, Heo J, Lee H, Kim BM, Kim DJ, Shin NY, Joo H, Yu S, Ahn SH, Sohn SI, Hong JH, Chang Y, Kim GS, Ok T, Lee JG, Chang JY, Seo JH, Lee S, Baek JH, Cho HJ, Yun J, Shin DH, Ha SH, Kim J, Yoo J, Baik M, Jung YH, Seo KD, Hwang YH, Park H, Kim CK, Kim JG, Lee IH, Choi JK, Jeon S, Lee HS, Kim KH, Kwon SU, Bang OY, Heo JH, Song TJ, Nam HS. Intensive Versus Conventional Blood Pressure Lowering After Successful Endovascular Thrombectomy: OPTIMAL-BP 1-Year Outcomes. Stroke. 2026 Aug;57(8):2364-2374. doi: 10.1161/STROKEAHA.126.055632. Epub 2026 May 29.

    PubMed 42212393

  • Yu R, Heo J, Park E, Joo H, Jung JW, Kim KH, Yun J, Lee H, 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, Jung YH, Hwang YH, Kim CK, Kim JG, Lee CJ, Park S, Lee HS, Kwon SU, Bang OY, Heo JH, Kim YD, Nam HS; OPTIMAL-BP trial investigators. Prognostic Modeling Based on Post-Endovascular Thrombectomy Systolic Blood Pressure Trajectories Using Explainable Artificial Intelligence: A Secondary Analysis of the OPTIMAL-BP Trial. J Med Syst. 2026 May 2;50(1):71. doi: 10.1007/s10916-026-02362-9.

    PubMed 42067698

  • Baik M, Jung JW, Lee H, Heo J, Kim YD, Joo H, Kim BM, Kim DJ, Shin NY, Cho BH, Ahn SH, Yun J, Park H, Sohn SI, Hong JH, Song TJ, Chang Y, Kim GS, Chang JY, Seo JH, Lee S, Baek JH, Cho HJ, Shin DH, Kim J, Yoo J, Seo KD, Jung YH, Hwang YH, Kim CK, Kim JG, Lee IH, Choi JK, Kim KH, Lee CJ, Park S, Jeon S, Lee HS, Kwon SU, Bang OY, Heo JH, Nam HS; OPTIMAL-BP Trial Investigators. Poorer Outcomes With Blood Pressure Lowering in Severe White Matter Disease After Thrombectomy. Stroke. 2026 May;57(5):1187-1195. doi: 10.1161/STROKEAHA.125.053191. Epub 2026 Feb 26.

    PubMed 41744094

  • 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.

    PubMed 40605757

  • 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.

    PubMed 40317165

  • 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.

    PubMed 39819210

  • 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.

    PubMed 37668619

  • 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.

    PubMed 34427481

Questions about this trial

What is this clinical trial studying?

A Phase 4 study of Ischemic Stroke, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rankin scale scores(mRS) (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04205305, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.

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