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

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The George Institute for Global Health, China
• Collaborators: First Affiliated Hospital of Chengdu Medical College; Shanghai East Hospital
• Treatments: Urapidil

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 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)