Outcome in Patients Treated With Intraarterial Thrombectomy - optiMAL Blood Pressure Control (OPTIMAL-BP)

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Labetalol; Nicardipine

Criteria

Inclusion Criteria:

1. Age ≥20 years, ≤95 years old

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 an average blood pressure ≥140 mmHg measured twice within 2 hours of successful recanalization.

Exclusion Criteria:

1. Age <20 or >95 years old

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.