INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial

An investigator initiated and conducted, prospective, multicentre, randomised outcome-blinded study for pre-hospital blood pressure lowering treatment in patients with presumed acute stroke

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900020534

Enrollment

Unknown

Registered

2019-01-07

Start date

2019-05-01

Completion date

Unknown

Last updated

2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute stroke

Interventions

intensive BP lowing:BP lowing at ambulance

control group:BP control according to local guildlines

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. aged =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 =150mmHg; 4. Able to provide brief informed consent (if a waver of consent is not approved by the ethics committee).

Exclusion criteria

Exclusion criteria: 1. Coma – no response to tactile stimuli or verbal stimuli; 2. Severe co-morbid disease (e.g. cancer, chronic airflow disease, severe heart failure); 3. History of epilepsy or seizure at onset; 4. History of recent head injury (<7 days); 5. Known definite contraindication to an intensive BP lowering regimen (eg severe carotid, vertebral or cerebral arterial stenosis, known Moya Moya disease or Takayasus arteritis, high-grade stenotic valvular heart disease, or severe renal failure); 6. Known advanced dementia or significant pre-stroke disability (eg mRS scores 3-5); 7. A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.

Design outcomes

Primary

Measure	Time frame
In cases of confirmed intracerebral haemorrhage (ICH), haematoma volume at 24 hours after stroke onset;	—

Secondary

Measure	Time frame
aematoma volume at presentation and degree of expansion over 24 hours;cerebral infarct size on MRI within 2 days in patients with acute ischaemic stroke (AIS); time to and frequency of reperfusion treatment (thrombolysis and/or thrombectomy); frequency of reperfusion treatment (thrombolysis and/or thrombectomy) related ICH;;death or neurological deterioration on the National Institute of Health stroke scale (NIHSS) at 24 hours and 7 days;length of hospital stay;functional shift (improvement) in mRS scores at 90 days (3 months);	—

Measure

Time frame

aematoma volume at presentation and degree of expansion over 24 hours;cerebral infarct size on MRI within 2 days in patients with acute ischaemic stroke (AIS); time to and frequency of reperfusion treatment (thrombolysis and/or thrombectomy); frequency of reperfusion treatment (thrombolysis and/or thrombectomy) related ICH;;death or neurological deterioration on the National Institute of Health stroke scale (NIHSS) at 24 hours and 7 days;length of hospital stay;functional shift (improvement) in mRS scores at 90 days (3 months);

—

Countries

China

Contacts

Public ContactCraig Anderson

The George Institute For Global Health At Peking University Health Science Center

canderson@georgeinstitute.org.cn+86 010 82800577 ext 557

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026