NCT04775147
Terminated
Not Applicable
Intensive Control of Blood Pressure in Acute Ischemic Stroke After Endovascular Therapy on Clinical Outcome:A Prospective Multicenter Randomized Controlled Trial (CRISIS I)
Nanjing First Hospital, Nanjing Medical University1 site in 1 country205 target enrollmentJuly 3, 2020
ConditionsAcute Ischemic Stroke
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Ischemic Stroke
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
- Enrollment
- 205
- Locations
- 1
- Primary Endpoint
- Level of disability
- Status
- Terminated
- Last Updated
- 2 years ago
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).
Investigators
Eligibility Criteria
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
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)
Study Sites (1)
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