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

Primary Purpose

Acute Ischemic Stroke

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intensive BP lowering
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Mechanical thrombectomy, Blood pressure management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nanjing First Hospital, Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Achieving SBP level of <120mmHg within 1 hour after successful recanalization, and maintaining this level at least 72 hours.

Maintaining SBP level of <140mmHg within 1 hour after successful recanalization, and maintaining this level at least 72 hours.

Outcomes

Primary Outcome Measures

Level of disability
a shift (improvement) in scores (0-6) on the modified Rankin scale

Secondary Outcome Measures

Intracerebral hemorrhage
Any or symptomatic ICH (sICH) after endovascular therapy
Death or neurological severity
Death or dependency measured by National Institutes of Health stroke scale (NIHSS)
BP lowering target (<120 mmHg)

Full Information

First Posted
February 25, 2021
Last Updated
July 21, 2023
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04775147
Brief Title
Intensive Control of Blood Pressure in Acute Ischemic Stroke After Endovascular Therapy on Clinical Outcome (CRISIS I)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Results of ENCHANTED have been published.
Study Start Date
July 3, 2020 (Actual)
Primary Completion Date
January 3, 2023 (Actual)
Study Completion Date
January 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Mechanical thrombectomy, Blood pressure management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Open intervention; outcome assessments undertaken by trained research staff who are kept blind to treatment allocation
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Achieving SBP level of <120mmHg within 1 hour after successful recanalization, and maintaining this level at least 72 hours.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Maintaining SBP level of <140mmHg within 1 hour after successful recanalization, and maintaining this level at least 72 hours.
Intervention Type
Other
Intervention Name(s)
Intensive BP lowering
Intervention Description
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)
Primary Outcome Measure Information:
Title
Level of disability
Description
a shift (improvement) in scores (0-6) on the modified Rankin scale
Time Frame
90 days (3months)
Secondary Outcome Measure Information:
Title
Intracerebral hemorrhage
Description
Any or symptomatic ICH (sICH) after endovascular therapy
Time Frame
90 day
Title
Death or neurological severity
Description
Death or dependency measured by National Institutes of Health stroke scale (NIHSS)
Time Frame
7 days
Title
BP lowering target (<120 mmHg)
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Nanjing First Hospital, Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China

12. IPD Sharing Statement

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

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