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

Phase 3

Completed

• Conditions: Stroke, Acute; Cerebrovascular Disorders
• Interventions: Drug: urapidil

• Registration Number: NCT03790800
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2018-12-26
• Study First Submitted QC: 2018-12-29
• Study First Posted: 2019-01-02
• Study Start: 2020-03-20
• Primary Completion: 2023-11-23
• Study Completion: 2023-11-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-22
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2425

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	urapidil	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
size of hematoma volume	Day 0	volume of hematoma at baseline measured on brain imaging
death or major disability	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.; mRS(3-6)
Death	Day 90
death or dependency measured by a shift in NIHSS	day 1 and day 7
Disability	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.
Health related quality of life	day 90	according to the EQ-5D

Trial Locations

Locations (4)

The George Institute for Global Health; 🇨🇳 Beijing, Beijing, China

Shanghai East Hospital; 🇨🇳 Shanghai, Shanghai, China

The First Affliated Hospital of Chengdu Medical College; 🇨🇳 Chengdu, Sichuan, China

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China; 🇨🇳 Chengdu, Sichuan, China