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

Not Applicable

Terminated

• Conditions: Acute Ischemic Stroke
• Interventions: Other: Intensive BP lowering

• Registration Number: NCT04775147
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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 Timeline

• Study Start: 2020-07-03
• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-01
• Status Verified: 2022-04
• Primary Completion: 2023-01-03
• Study Completion: 2023-01-03
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 205

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Intensive BP lowering	Achieving SBP level of \<120mmHg within 1 hour after successful recanalization, and maintaining this level at least 72 hours.

Primary Outcome Measures

Name	Time	Method
Level of disability	90 days (3months)	a shift (improvement) in scores (0-6) on the modified Rankin scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nanjing First Hospital, Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China