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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 : Not yet recruiting
First Posted : January 1, 2019
Last Update Posted : January 1, 2019
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 pre-hospital blood pressure (BP) lowering initiated in ambulance setting on (i) hematoma volume at 24 hours in patients with confirmed intracerebral haemorrhage (ICH), and (ii) safety in patients with confirmed acute ischaemic 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 pre-hospital BP lowering initiated in ambulance settings on haematoma volume at 24 hours in ICH patients, the time to and rate of reperfusion treatment (thrombolysis and/or thrombectomy) in those with acute ischemic stroke, and functional outcomes at 90 days and safety in all participating patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial
Estimated Study Start Date : May 1, 2019
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. haematoma volume [ Time Frame: Day 1 ]
    In cases of confirmed intracerebral haemorrhage (ICH), haematoma volume measured on brain CT scan at 24 hours after stroke onset


Secondary Outcome Measures :
  1. Haematoma volume at presentation [ Time Frame: Day 0 ]
    In cases of confirmed intracerebral haemorrhage (ICH), haematoma volume measured on brain CT scan at admission to hospital

  2. functional recovery [ Time Frame: Day 90 ]
    measure of disability on the modified Rankin scale (mRS), where scores range from 0 (no symptoms) to 6, with a score of 0 and 1 indicating no or some symptoms, respectively, 2-5 indicate increasing levels of disability/dependency, and 6 death.

  3. cerebral infarct size [ Time Frame: Day 2 ]
    cerebral infarct size on MRI within 2 days in patients with acute ischaemic stroke

  4. reperfusion treatment [ Time Frame: Day 0 ]
    frequency of reperfusion treatment (thrombolysis and/or thrombectomy) in all confirmed acute ischemic stroke

  5. time to reperfusion treatment [ Time Frame: Day 0 ]
    time from stroke onset to reperfusion treatment in those patients who undergoing from from symptom onset to the time of reperfusion (thrombolysis and/or thrombectomy)

  6. reperfusion treatment related symptomatic intracerebral hemorrhage [ Time Frame: Day 7 ]
    symptomatic intracerebral hemorrhage according to standard measure after reperfusion treatment

  7. change in hematoma volume [ Time Frame: Day 1 ]
    hematoma volume growth 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 heart failure);
  3. History of epilepsy or seizure at onset;
  4. History of recent head injury (<7 days);
  5. Known definite contraindication to an intensive BP lowering regimen (eg severe carotid, vertebral or cerebral arterial stenosis, known MoyaMoya disease or Takayasu's arteritis, high-grade stenotic valvular heart disease, or severe renal failure);
  6. Known advanced dementia or significant pre-stroke disability (eg mRS scores 3-5);
  7. A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.

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 Not yet recruiting
Beijing, Beijing, China, 100088
Contact: Lily Song    +86 13916466400    lsong@georgeinstitute.org.cn   
Contact: Feifeng Liu    +86 15121100573    liufeifeng7@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     History of Changes
Other Study ID Numbers: INTERACT4
First Posted: January 1, 2019    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018
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