Intensive Control of Blood Pressure in Acute Ischemic Stroke After Endovascular Therapy on Clinical Outcome:A Prospective Multicenter Randomized Controlled Trial (CRISIS I)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 205
- Locations
- 1
- Primary Endpoint
- Level of disability
Study Overview
Brief Summary
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
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Open intervention; outcome assessments undertaken by trained research staff who are kept blind to treatment allocation
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention group
Achieving SBP level of <120mmHg within 1 hour after successful recanalization, and maintaining this level at least 72 hours.
Intervention: Intensive BP lowering (Other)
Control group
Maintaining SBP level of <140mmHg within 1 hour after successful recanalization, and maintaining this level at least 72 hours.
Outcomes
Primary Outcomes
Level of disability
Time Frame: 90 days (3months)
a shift (improvement) in scores (0-6) on the modified Rankin scale
Secondary Outcomes
- Intracerebral hemorrhage(90 day)
- Death or neurological severity(7 days)
- BP lowering target (<120 mmHg)(3 days)