Clinical trial NCT04205305: Outcome in Patients Treated with Intraarterial Thrombectomy - OptiMAL Blood Pressure Control (OPTIMAL-BP)
Official title: Outcome in Patients Treated with Intraarterial Thrombectomy - OptiMAL Blood Pressure Control (OPTIMAL-BP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Stroke
Keywords: Acute ischemic stroke
blood pressure
hypertension
endovascular thrombectomy
recanalization
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 306
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥20 years
2. Acute ischemic stroke patients who underwent intraarterial treatment for large vessel occlusion. (ICA, MCA M1 or M2, ACA A1, PCA P1)
3. 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Modified Rankin scale scores(mRS)
timeFrame: 90 days
measure: symptomatic intracerebral hemorrhage: Number of participants with symptomatic intracerebral hemorrhage
timeFrame: 36 hours
measure: Death related to the index stroke within 90 days
timeFrame: 90 days
Secondary outcomes:
measure: BP parameters - systolic blood pressure
timeFrame: 24 hour
measure: BP parameters - diastolic blood pressure
timeFrame: 24 hour
measure: BP parameters - blood pressure variability
timeFrame: 24 hour
measure: Functional independence
timeFrame: 1 month
measure: Distribution of the modified Rankin scores (shift analysis)
timeFrame: 90 days
measure: National Institutes of Health Stroke Scale(NIHSS) score
timeFrame: 24 hour
measure: Excellent recovery
timeFrame: 24 hour
measure: Recanalization status on CT Angiography(CTA) or MR Angiography(MRA)
timeFrame: 24±12 hour
measure: Quality of life measured by Euro-QoL
timeFrame: 90 days
measure: Number of participants with malignant brain edema
timeFrame: 24 hour
measure: Number of participants with treatment failure
timeFrame: 24 hour
measure: CT or MRI ASPECTS(Alberta Stroke Program Early CT Score)
timeFrame: 36 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Neurology, Yonsei University College of Medicine
Study officials:
References:
citation: 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. 2021 Aug 29:17474930211041213. doi: 10.1177/17474930211041213. Online ahead of print.