Outcome in Patients Treated with Intraarterial Thrombectomy - OptiMAL Blood Pressure Control (OPTIMAL-BP)
Overview
- Phase
- Phase 4
- Intervention
- conventional blood pressure control (labetalol, nicardipine)
- Conditions
- Ischemic Stroke
- Sponsor
- Yonsei University
- Enrollment
- 306
- Locations
- 1
- Primary Endpoint
- Modified Rankin scale scores(mRS)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
- •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
- •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
Arms & Interventions
Conventional blood pressure control group
systolic blood pressure \<180 mmHg
Intervention: conventional blood pressure control (labetalol, nicardipine)
Intensive blood pressure control group
systolic blood pressure \<140 mmHg
Intervention: intensive blood pressure control (labetalol, nicardipine)
Outcomes
Primary Outcomes
Modified Rankin scale scores(mRS)
Time Frame: 90 days
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.
symptomatic intracerebral hemorrhage: Number of participants with symptomatic intracerebral hemorrhage
Time Frame: 36 hours
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.
Death related to the index stroke within 90 days
Time Frame: 90 days
Secondary Outcomes
- 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)
- National Institutes of Health Stroke Scale(NIHSS) score(24 hour)
- Excellent recovery(24 hour)
- Recanalization status on CT Angiography(CTA) or MR Angiography(MRA)(24±12 hour)
- Quality of life measured by Euro-QoL(90 days)
- Number of participants with malignant brain edema(24 hour)
- Number of participants with treatment failure(24 hour)
- CT or MRI ASPECTS(Alberta Stroke Program Early CT Score)(36 hour)