NCT04205305

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-18
• Primary completion: 2023-07-23
• Completion: 2023-07-23
• First posted: 2019-12-19
• Last updated: 2025-03-19

Locations

1 site across 1 country: South Korea