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Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial (INTERACT4)

Primary Purpose

Stroke, Acute, Cerebrovascular Disorders

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
urapidil
Sponsored by
The George Institute for Global Health, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring stroke, blood pressure control, hypertension, clinical trial, ambulances

Eligibility Criteria

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

Inclusion Criteria:

  1. age ≥18 years;
  2. Acute syndrome that is due to presumed acute stroke, defined as FAST（Face, Arm, Speech, Time） scores of ≥2 with an arm motor deficit and time ≤2 hours from last seen well;
  3. Systolic BP ≥150
  4. Able to provide brief informed consent (if a waver of consent is not approved by the ethics committee)

Exclusion Criteria:

  1. Coma - no response to tactile stimuli or verbal stimuli;
  2. Severe co-morbid disease (e.g. cancer, chronic airflow disease, severe dementia,severe heart failure,pre-stroke disability[needed help]);
  3. History of epilepsy or seizure at onset;
  4. History of recent head injury (<7 days);
  5. Hypoglycemia(glucose<2.8mmol/L)

Sites / Locations

  • The George Institute for Global Health
  • Shanghai East HospitalRecruiting
  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, ChinaRecruiting
  • The First Affliated Hospital of Chengdu Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

control group

Arm Description

If systolic blood pressure>180:IV Urapidil 25mg If systolic blood pressure>150 (or 5 mins after first bolus) : IV Urapidil 25mg and to maintain this level after admission to hospital in those with confirmed acute stroke for the next 7 days (or hospital discharge if earlier)

To receive blood pressure management according to standard local guidelines which recommend blood pressure lowering in hospital if systolic level is >220mmHg. This level will be considered by ambulance staff as a threshold for treatment if considered clinically important.

Outcomes

Primary Outcome Measures

level of physical function
Level of function defined across 7 categories of disability on the modified Rankin scale （mRS 0-6) in which scores of 0 or 1 indicate good function without or with symptoms but not disability, socress of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death.

Secondary Outcome Measures

number of patients with serious adverse events
total number of serious adverse events reported during follow-up, according to standard definitions
number of patients with any intracranial hemorrhage
reperfusion treatment (thrombolysis/thrombectomy) related symptomatic intracerebral number of cases of intracranial hemorrhage, according to standard definitions
size of cerebral infarction
overall size of cerebral infarction on MRI within 2 days in cases of ischaemic stroke
number of patients who receive reperfusion treatment
total number of cases of reperfusion (thrombolysis and/or thrombectomy) in ischemic stroke
time to use of reperfusion treatment
time from symptom onset to reperfusion treatment in patients with ischemic stroke
size of hematoma volume
change in volume of hematoma from baseline to 24 hours, measured on brain imaging
size of hematoma volume
volume of hematoma at baseline measured on brain imaging
death or major disability
Level of function defined across 7 categories of disability on the modified Rankin scale （mRS 0-6) in which scores of 0 or 1 indicate good function without or with symptoms but not disability, socress of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death. mRS(3-6)
Death
Disability
Level of function defined across 7 categories of disability on the modified Rankin scale （mRS 0-6) in which scores of 0 or 1 indicate good function without or with symptoms but not disability, socress of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death.
death or dependency measured by a shift in NIHSS
Health related quality of life
according to the EQ-5D

Full Information

First Posted
December 26, 2018
Last Updated
November 4, 2022
Sponsor
The George Institute for Global Health, China
Collaborators
Shanghai East Hospital, China, First Affiliated Hospital of Chengdu Medical College, China, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT03790800
Brief Title
Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial
Acronym
INTERACT4
Official Title
Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The George Institute for Global Health, China
Collaborators
Shanghai East Hospital, China, First Affiliated Hospital of Chengdu Medical College, China, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China

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
A multicentre, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) study to assess the effects of hyperacute intensive blood pressure (BP) lowering initiated in ambulance setting on (i) functional outcome in patients with acute stroke (ii) safety in patients with confirmed acute stroke and other conditions that were initially suspected as acute stroke (i.e. stroke mimic).
Detailed Description
As an investigator initiated and conducted, multicentre, ambulance-delivered, prospective, randomised, open-label, blinded outcome (PROBE) study. INTERACT4 aims to evaluate the effects of functional outcome according to an ordinal analysis of the full range of scores on the mRS, the safety in all randomised patients; reperfusion treatment (thrombolysis and/or thrombectomy) related symptomatic ICH (sICH, according to standard definitions), infarct size, the time to and overall rate of reperfusion treatment in AIS patients; hematoma volume and early expansion in ICH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Cerebrovascular Disorders
Keywords
stroke, blood pressure control, hypertension, clinical trial, ambulances

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
central randomization with stratification
Masking
Outcomes Assessor
Masking Description
Outcome assessor is independent of the treatment team
Allocation
Randomized
Enrollment
2320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
If systolic blood pressure>180:IV Urapidil 25mg If systolic blood pressure>150 (or 5 mins after first bolus) : IV Urapidil 25mg and to maintain this level after admission to hospital in those with confirmed acute stroke for the next 7 days (or hospital discharge if earlier)
Arm Title
control group
Arm Type
No Intervention
Arm Description
To receive blood pressure management according to standard local guidelines which recommend blood pressure lowering in hospital if systolic level is >220mmHg. This level will be considered by ambulance staff as a threshold for treatment if considered clinically important.
Intervention Type
Drug
Intervention Name(s)
urapidil
Other Intervention Name(s)
Intensive BP lowing
Intervention Description
A standard treatment regime based on intravenous (IV) bolus of 25mg urapidil administered over 1 minute. For those patients initial systolic blood pressure 180, another 25mg urapidil bolus will be given if the systolic blood pressure level persists >150 after 5 minutes.
Primary Outcome Measure Information:
Title
level of physical function
Description
Level of function defined across 7 categories of disability on the modified Rankin scale （mRS 0-6) in which scores of 0 or 1 indicate good function without or with symptoms but not disability, socress of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death.
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
number of patients with serious adverse events
Description
total number of serious adverse events reported during follow-up, according to standard definitions
Time Frame
Day 90
Title
number of patients with any intracranial hemorrhage
Description
reperfusion treatment (thrombolysis/thrombectomy) related symptomatic intracerebral number of cases of intracranial hemorrhage, according to standard definitions
Time Frame
Day 7
Title
size of cerebral infarction
Description
overall size of cerebral infarction on MRI within 2 days in cases of ischaemic stroke
Time Frame
Day 2
Title
number of patients who receive reperfusion treatment
Description
total number of cases of reperfusion (thrombolysis and/or thrombectomy) in ischemic stroke
Time Frame
Day 0
Title
time to use of reperfusion treatment
Description
time from symptom onset to reperfusion treatment in patients with ischemic stroke
Time Frame
Day 0
Title
size of hematoma volume
Description
change in volume of hematoma from baseline to 24 hours, measured on brain imaging
Time Frame
Day 1
Title
size of hematoma volume
Description
volume of hematoma at baseline measured on brain imaging
Time Frame
Day 0
Title
death or major disability
Description
Level of function defined across 7 categories of disability on the modified Rankin scale （mRS 0-6) in which scores of 0 or 1 indicate good function without or with symptoms but not disability, socress of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death. mRS(3-6)
Time Frame
Day 90
Title
Death
Time Frame
Day 90
Title
Disability
Description
Level of function defined across 7 categories of disability on the modified Rankin scale （mRS 0-6) in which scores of 0 or 1 indicate good function without or with symptoms but not disability, socress of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death.
Time Frame
Day 90
Title
death or dependency measured by a shift in NIHSS
Time Frame
day 1 and day 7
Title
Health related quality of life
Description
according to the EQ-5D
Time Frame
day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age ≥18 years; Acute syndrome that is due to presumed acute stroke, defined as FAST（Face, Arm, Speech, Time） scores of ≥2 with an arm motor deficit and time ≤2 hours from last seen well; Systolic BP ≥150 Able to provide brief informed consent (if a waver of consent is not approved by the ethics committee) Exclusion Criteria: Coma - no response to tactile stimuli or verbal stimuli; Severe co-morbid disease (e.g. cancer, chronic airflow disease, severe dementia,severe heart failure,pre-stroke disability[needed help]); History of epilepsy or seizure at onset; History of recent head injury (<7 days); Hypoglycemia(glucose<2.8mmol/L)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lily Song
Phone
+86 13916466400
Email
lsong@georgeinstitute.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Anderson
Organizational Affiliation
The George Institute for Global Health, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gang Li
Organizational Affiliation
Shanghai East Hospital, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jie Yang
Organizational Affiliation
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yapeng Lin
Organizational Affiliation
The First Affliated Hospital of Chengdu Medical College, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
The George Institute for Global Health
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100088
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200123
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Li, MD
Phone
+86 18017187086
Email
ligang@tongji.edu.cn
Facility Name
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Yang
Phone
+86 13678130516
Email
yangjie1126@163.com
Facility Name
The First Affliated Hospital of Chengdu Medical College
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610500
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yapeng Lin
Phone
+86 13540389801
Email
1009549973@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared with bona fide researchers after 1 year following conclusion of the study, based on a submitted protocol to the research office of The George Institute for Global Health, Sydney Australia
IPD Sharing Time Frame
1 year after conclusion of the study
IPD Sharing Access Criteria
genuine researcher with supporting institution protocol review and approval by the research office of The George Institute
IPD Sharing URL
http://georgeinstitute.org.au
Citations:
PubMed Identifier
34872617
Citation
Song L, Chen C, Chen X, Guo Y, Liu F, Lin Y, Billot L, Li Q, Liu H, Si L, Ouyang M, Arima H, Bath PM, Ford GA, Robinson T, Sandset EC, Saver JL, Sprigg N, van der Worp HB, Zhang C, Yang J, Li G, Anderson CS; INTERACT4 investigators. INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): study protocol for a randomized controlled trial. Trials. 2021 Dec 6;22(1):885. doi: 10.1186/s13063-021-05860-y.
Results Reference
derived

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Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial

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