Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial (INTERACT4)
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| ClinicalTrials.gov Identifier: NCT03790800 |
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Recruitment Status :
Recruiting
First Posted : January 2, 2019
Last Update Posted : May 25, 2021
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Sponsor:
The George Institute for Global Health, China
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
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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 |
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.
| 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 |
|---|---|
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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)
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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 |
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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.
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Primary Outcome Measures :
- 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 :
- 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
- 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
- size of cerebral infarction [ Time Frame: Day 2 ]overall size of cerebral infarction on MRI within 2 days in cases of ischaemic stroke
- number of patients who receive reperfusion treatment [ Time Frame: Day 0 ]total number of cases of reperfusion (thrombolysis and/or thrombectomy) in ischemic stroke
- time to use of reperfusion treatment [ Time Frame: Day 0 ]time from symptom onset to reperfusion treatment in patients with ischemic stroke
- 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
- 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:
- 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)
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
| Contact: Lily Song | +86 13916466400 | lsong@georgeinstitute.org.cn |
Locations
| 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: Gang Li, MD 86 ext 18017187086 ligang@tongji.edu.cn | |
| China, Sichuan | |
| The first affliated hospital of Chengdu medical college | Recruiting |
| Chengdu, Sichuan, China, 610500 | |
| Contact: Jie Yang 86 ext 13678130516 yangjie1126@163.com | |
Sponsors and Collaborators
The George Institute for Global Health, China
Shanghai East Hospital
First Affiliated Hospital of Chengdu Medical College
Investigators
| Principal Investigator: | Craig Anderson | The George Institute for Global Health, China | |
| Principal Investigator: | Gang Li | Shanghai East Hospital | |
| Principal Investigator: | Jie Yang | The First Affliated Hospital of Chengdu Medical College |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | May 25, 2021 |
| Last Verified: | May 2021 |
| 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 |
| 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:
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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 |