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

Stroke, Acute Clinical Trial

— INTERACT4  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03790800
• Other study ID #: INTERACT4
• Status: Completed
• Phase: Phase 3
• Start date: March 20, 2020
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2023
• Source: The George Institute for Global Health, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2425
• Est. completion date: November 30, 2023
• Est. primary completion date: November 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Stroke
• Stroke, Acute

Intervention

Drug:
• urapidil
A standard treatment regime based on intravenous (IV) bolus of 25mg urapidil administered over 1 minute. For those patients initial systolic blood pressure 180, another 25mg urapidil bolus will be given if the systolic blood pressure level persists >150 after 5 minutes.

Locations

Country	Name	City	State
China	The George Institute for Global Health	Beijing	Beijing
China	Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China	Chengdu	Sichuan
China	The First Affliated Hospital of Chengdu Medical College	Chengdu	Sichuan
China	Shanghai East Hospital	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
The George Institute for Global Health, China	First Affiliated Hospital of Chengdu Medical College, China, Shanghai East Hospital, China, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of physical function	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.	Day 90
Secondary	number of patients with serious adverse events	total number of serious adverse events reported during follow-up, according to standard definitions	Day 90
Secondary	number of patients with any intracranial hemorrhage	reperfusion treatment (thrombolysis/thrombectomy) related symptomatic intracerebral number of cases of intracranial hemorrhage, according to standard definitions	Day 7
Secondary	size of cerebral infarction	overall size of cerebral infarction on MRI within 2 days in cases of ischaemic stroke	Day 2
Secondary	number of patients who receive reperfusion treatment	total number of cases of reperfusion (thrombolysis and/or thrombectomy) in ischemic stroke	Day 0
Secondary	time to use of reperfusion treatment	time from symptom onset to reperfusion treatment in patients with ischemic stroke	Day 0
Secondary	size of hematoma volume	change in volume of hematoma from baseline to 24 hours, measured on brain imaging	Day 1
Secondary	size of hematoma volume	volume of hematoma at baseline measured on brain imaging	Day 0
Secondary	death or major disability	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)	Day 90
Secondary	Death		Day 90
Secondary	Disability	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.	Day 90
Secondary	death or dependency measured by a shift in NIHSS		day 1 and day 7
Secondary	Health related quality of life	according to the EQ-5D	day 90