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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03790800
Other study ID # INTERACT4
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 20, 2020
Est. completion date November 30, 2023

Study information

Verified date December 2023
Source The George Institute for Global Health, China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 2425
Est. completion date November 30, 2023
Est. primary completion date November 23, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
urapidil
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.

Locations

Country Name City State
China The George Institute for Global Health Beijing Beijing
China Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China Chengdu Sichuan
China The First Affliated Hospital of Chengdu Medical College Chengdu Sichuan
China Shanghai East Hospital Shanghai Shanghai

Sponsors (4)

Lead Sponsor Collaborator
The George Institute for Global Health, China First Affiliated Hospital of Chengdu Medical College, China, Shanghai East Hospital, China, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Day 90
Secondary number of patients with serious adverse events total number of serious adverse events reported during follow-up, according to standard definitions Day 90
Secondary number of patients with any intracranial hemorrhage reperfusion treatment (thrombolysis/thrombectomy) related symptomatic intracerebral number of cases of intracranial hemorrhage, according to standard definitions Day 7
Secondary size of cerebral infarction overall size of cerebral infarction on MRI within 2 days in cases of ischaemic stroke Day 2
Secondary number of patients who receive reperfusion treatment total number of cases of reperfusion (thrombolysis and/or thrombectomy) in ischemic stroke Day 0
Secondary time to use of reperfusion treatment time from symptom onset to reperfusion treatment in patients with ischemic stroke Day 0
Secondary size of hematoma volume change in volume of hematoma from baseline to 24 hours, measured on brain imaging Day 1
Secondary size of hematoma volume volume of hematoma at baseline measured on brain imaging Day 0
Secondary 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)
Day 90
Secondary Death Day 90
Secondary 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. Day 90
Secondary death or dependency measured by a shift in NIHSS day 1 and day 7
Secondary Health related quality of life according to the EQ-5D day 90
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