Status:
COMPLETED
Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial
Lead Sponsor:
The George Institute for Global Health, China
Collaborating Sponsors:
Shanghai East Hospital, China
First Affiliated Hospital of Chengdu Medical College, China
Conditions:
Stroke, Acute
Cerebrovascular Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ambulanc...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
2425 Patients enrolled
Trial Details
Trial ID
NCT03790800
Start Date
March 20 2020
End Date
November 30 2023
Last Update
March 26 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
The George Institute for Global Health
Beijing, Beijing Municipality, China, 100088
2
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200123
3
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China
Chengdu, Sichuan, China, 610000
4
The First Affliated Hospital of Chengdu Medical College
Chengdu, Sichuan, China, 610500