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

Sponsor
Yonsei University
Study ID
NCT04205305
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 18, 2020
Status verified
Mar 2025
Primary completion
Jul 23, 2023
Completion
Jul 23, 2023

Study Design

Enrollment
306 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Conventional blood pressure control group
    systolic blood pressure \<180 mmHg
  • Experimental: Intensive blood pressure control group
    systolic blood pressure \<140 mmHg

Primary Outcome Measure

Modified Rankin scale scores(mRS) [ Time Frame: 90 days ]

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