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

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ClinicalTrials.gov Identifier: NCT03790800
Recruitment Status : Recruiting
First Posted : January 2, 2019
Last Update Posted : August 26, 2020
Sponsor:
Collaborators:
Shanghai East Hospital
First Affiliated Hospital of Chengdu Medical College
Information provided by (Responsible Party):
Craig Anderson, The George Institute for Global Health, China

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).

Condition or disease Intervention/treatment Phase
Stroke, Acute Cerebrovascular Disorders Drug: urapidil Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: central randomization with stratification
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessor is independent of the treatment team
Primary Purpose: Treatment
Official Title: Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial
Actual Study Start Date : March 20, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: Intervention group
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)
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.
Other Name: Intensive BP lowing

No Intervention: control group
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.



Primary Outcome Measures :
  1. level of physical function [ Time Frame: Day 90 ]
    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 :
  1. number of patients with serious adverse events [ Time Frame: Day 90 ]
    total number of serious adverse events reported during follow-up, according to standard definitions

  2. number of patients with any intracranial hemorrhage [ Time Frame: Day 7 ]
    reperfusion treatment (thrombolysis/thrombectomy) related symptomatic intracerebral number of cases of intracranial hemorrhage, according to standard definitions

  3. size of cerebral infarction [ Time Frame: Day 2 ]
    overall size of cerebral infarction on MRI within 2 days in cases of ischaemic stroke

  4. number of patients who receive reperfusion treatment [ Time Frame: Day 0 ]
    total number of cases of reperfusion (thrombolysis and/or thrombectomy) in ischemic stroke

  5. time to use of reperfusion treatment [ Time Frame: Day 0 ]
    time from symptom onset to reperfusion treatment in patients with ischemic stroke

  6. number of patients with symptomatic intracerebral hemorrhage [ Time Frame: Day 7 ]
    number of cases of symptomatic intracerebral hemorrhage according to standard measure after reperfusion treatment

  7. size of hematoma volume [ Time Frame: Day 1 ]
    change in volume of hematoma from baseline to 24 hours, measured on brain imaging



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790800


Contacts
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Contact: Lily Song +86 13916466400 lsong@georgeinstitute.org.cn

Locations
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China, Beijing
The George Institute for Global Health Active, not recruiting
Beijing, Beijing, China, 100088
China, Shanghai
Shanghai East Hospital Recruiting
Shanghai, Shanghai, China, 200123
Contact: Huan Bao, MD    13917750525 ext 15921119641    baohuan258@163.com   
Contact: Lian Zuo, MD    13564669196    mizzmy@163.com   
China, Sichuan
The first affliated hospital of Chengdu medical college Recruiting
Chengdu, Sichuan, China, 610500
Contact: Qian Yang, Master    18349185156    yangq0812@163.com   
Contact: Lili Zhang, Master    13880039591    zhanglili201908@163.com   
Sponsors and Collaborators
The George Institute for Global Health, China
Shanghai East Hospital
First Affiliated Hospital of Chengdu Medical College
Investigators
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Principal Investigator: Craig Anderson The George Institute for Global Health, China
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Responsible Party: Craig Anderson, Executive Director, The George Institute for Global Health, China
ClinicalTrials.gov Identifier: NCT03790800    
Other Study ID Numbers: INTERACT4
First Posted: January 2, 2019    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 1 year after conclusion of the study
Access Criteria: genuine researcher with supporting institution protocol review and approval by the research office of The George Institute
URL: http://georgeinstitute.org.au

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Craig Anderson, The George Institute for Global Health, China:
stroke
blood pressure control
hypertension
clinical trial
ambulances
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Urapidil
Antihypertensive Agents
Vasodilator Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents