INTERACT4: Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| 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.
Study Design
Arms and Interventions
| 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 Names:
|
| 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. |
Outcome Measures
Primary Outcome Measures
- level of physical function [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 [Day 90]
total number of serious adverse events reported during follow-up, according to standard definitions
- number of patients with any intracranial hemorrhage [Day 7]
reperfusion treatment (thrombolysis/thrombectomy) related symptomatic intracerebral number of cases of intracranial hemorrhage, according to standard definitions
- size of cerebral infarction [Day 2]
overall size of cerebral infarction on MRI within 2 days in cases of ischaemic stroke
- number of patients who receive reperfusion treatment [Day 0]
total number of cases of reperfusion (thrombolysis and/or thrombectomy) in ischemic stroke
- time to use of reperfusion treatment [Day 0]
time from symptom onset to reperfusion treatment in patients with ischemic stroke
- number of patients with symptomatic intracerebral hemorrhage [Day 7]
number of cases of symptomatic intracerebral hemorrhage according to standard measure after reperfusion treatment
- size of hematoma volume [Day 1]
change in volume of hematoma from baseline to 24 hours, measured on brain imaging
Eligibility Criteria
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;
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Systolic BP ≥150
-
Able to provide brief informed consent (if a waver of consent is not approved by the ethics committee)
Exclusion Criteria:
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Coma - no response to tactile stimuli or verbal stimuli;
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Severe co-morbid disease (e.g. cancer, chronic airflow disease, severe dementia,severe heart failure,pre-stroke disability[needed help]);
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History of epilepsy or seizure at onset;
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History of recent head injury (<7 days);
-
Hypoglycemia(glucose<2.8mmol/L)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The George Institute for Global Health | Beijing | Beijing | China | 100088 |
| 2 | Shanghai East Hospital | Shanghai | Shanghai | China | 200123 |
| 3 | The first affliated hospital of Chengdu medical college | Chengdu | Sichuan | China | 610500 |
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INTERACT4