Intensive Control of Blood Pressure in Acute Ischemic Stroke After Endovascular Therapy on Clinical Outcome (CRISIS I)

Study Overview
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Brief Summary
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CRISIS I is a prospective, multicenter, randomized controlled trial, to asses the impact of intensive blood pressure control on clinical outcome of acute ischemic stroke patients with successful recanalization after endovascular therapy.

Detailed Description
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CRISIS I aims to determine the effectiveness of more intensive BP lowering target (<120 mmHg) compared to standard BP management target (<140mmHg) on functional outcome in patients with successful recanalization post-MT for AIS due to anterior circulation large vessel occlusion (LVO).

Official Title
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Intensive Control of Blood Pressure in Acute Ischemic Stroke After Endovascular Therapy on Clinical Outcome:A Prospective Multicenter Randomized Controlled Trial (CRISIS I)

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Other: Intensive BP lowering


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Diagnosis of AIS with anterior circulation LVO confirmed by brain imaging To receive MT <24 hours after AIS onset according to local guidelines Successful recanalization (TICI score ≥2b) after MT Sustained systolic BP ≥140 mmHg (defined as 2 successive readings <10 mins) within 60 minutes after recanalization Provide written informed consent (or approved surrogate) Perform CTA or MRI before endovascular therapy Signed an approved informed consents Exclusion Criteria: Significant pre-stroke disability (mRS scores 2-5) Definite indication/contraindication to different intensities of BP lowering treatment Specific contraindications to any of the BP agents to be used (eg, patients who are hypersensitive (allergic) to any of the ingredients) Unlikely to potentially benefit from therapy (e.g. advanced dementia) or very high likelihood of death within 24 hours post-MT, judged by responsible treating clinician Other medical illness that interferes with outcome assessments and follow-up (e.g.advance cancer and renal failure); Women who are lactating Other conditions inappropriate for inclusion judged by investigators

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Achieving SBP level of <120mmHg within 1 hour after successful recanalization, and maintaining this level at least 72 hours. | Other: Intensive BP lowering<br>* The aim is to achieve a systolic BP level of <120mmHg within 1hour after successful recanalization and to maintain this BP level for the next 72 hours (or until hospital discharge or death of this should occur earlier)<br>|
| No Intervention: Control group<br>Maintaining SBP level of <140mmHg within 1 hour after successful recanalization, and maintaining this level at least 72 hours. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of disability | a shift (improvement) in scores (0-6) on the modified Rankin scale | 90 days (3months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracerebral hemorrhage | Any or symptomatic ICH (sICH) after endovascular therapy | 90 day | 
| Death or neurological severity | Death or dependency measured by National Institutes of Health stroke scale (NIHSS) | 7 days | 
| BP lowering target (<120 mmHg) |  | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical thrombectomy, Blood pressure management