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

The George Institute for Global Health, China

Status and phase: Completed; Phase 3

Conditions: Stroke, Acute; Cerebrovascular Disorders

Treatments: Drug: urapidil

Study type: Interventional

Funder types: Other

Identifiers

NCT03790800

INTERACT4

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2,425 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,425 participants in 2 patient groups

Intervention group

Experimental group

Description:

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)

Treatment:

Drug: urapidil

control group

No Intervention group

Description:

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.