Outcome in Patients Treated With Endovascular Thrombectomy - optIMAL Blood Pressure Control 2 (OPTIMAL-BP 2)

Sponsor
Yonsei University
Study ID
NCT06677970
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

Study Details

Though intravenous thrombolysis has been shown to improve symptoms in acute ischemic stroke patients, the recanalization rate remains low (22.6%) and only around 30% of patients benefit from the treatment. Recently, endovascular thrombectomy using stent retrievers or catheters has proven to be more effective, with a success rate of nearly 80%. However, only 50% of patients experience clinical improvement, highlighting the need for new treatment strategies to enhance outcomes. Current guidelines recommend maintaining systolic blood pressure (BP) below 180 mmHg after thrombectomy, but there is a lack of evidence regarding optimal blood pressure management post-reperfusion. Four randomized clinical trials, including the OPTIMAL-BP trial, have examined blood pressure control following thrombectomy. Meta-analyses showed that intensive BP lowering did not reduce symptomatic hemorrhage and was associated with worse functional outcomes at 3 months. Specifically, lowering BP too aggressively after successful reperfusion could worsen outcomes by reducing perfusion to the ischemic penumbra. Therefore, this study will investigate whether a more targeted blood pressure elevation strategy could improve patient prognosis compared to standard BP control in patients with sustained systolic blood pressure (SBP) \<150 mmHg on successive measurements obtained less than 10 minutes apart within 3 hours after reperfusion. This is a prospective, randomized, open-label trial with blinded endpoint assessment (PROBE) design, aimed at comparing intensive and standard BP control strategies in acute ischemic stroke patients. Participants will be randomized 1:1 into either an intensive BP control group (targeting a 20% systolic BP increase, capped at less than 160 mmHg) or a standard BP control group (systolic BP at or below 180 mmHg).

Key Dates

Start date
Oct 1, 2024
Status verified
Feb 2026
Primary completion
Dec 3, 2029
Completion
Dec 3, 2029

Study Design

Enrollment
176 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Conventional BP magnagement group (SBP ≤180 mmHg)
  • Active Comparator: Intensive BP raising group (20% increase in SBP, maximum of 160 mmHg )

Primary Outcome Measure

Functinal independence [ Time Frame: 3 months ]

Central Contacts

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