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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04775147
• Other study ID #: CRISIS I
• Status: Terminated
• Phase: N/A
• Start date: July 3, 2020
• Est. completion date: January 3, 2023

Study information

• Verified date: April 2022
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 205
• Est. completion date: January 3, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• Intensive BP lowering
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)

Locations

Country	Name	City	State
China	Nanjing First Hospital, Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of disability	a shift (improvement) in scores (0-6) on the modified Rankin scale	90 days (3months)
Secondary	Intracerebral hemorrhage	Any or symptomatic ICH (sICH) after endovascular therapy	90 day
Secondary	Death or neurological severity	Death or dependency measured by National Institutes of Health stroke scale (NIHSS)	7 days
Secondary	BP lowering target (<120 mmHg)		3 days