Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai East Hospital, China | UNKNOWN |
| First Affiliated Hospital of Chengdu Medical College | OTHER |
| Sichuan Academy of Medical Sciences | OTHER |
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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) |
|
| control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| urapidil | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients with serious adverse events | total number of serious adverse events reported during follow-up, according to standard definitions | Day 90 |
| number of patients with any intracranial hemorrhage |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Craig Anderson | The George Institute for Global Health, China | Principal Investigator |
| Lili Song | The George Institute for Global Health, China | Principal Investigator |
| Gang Li | Shanghai East Hospital, China | Principal Investigator |
| Jie Yang | Sichuan Academy of Medical Sciences | Principal Investigator |
| Yapeng Lin | The First Affliated Hospital of Chengdu Medical College, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The George Institute for Global Health | Beijing | Beijing Municipality | 100088 | China | ||
| Shanghai East Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41855454 | Derived | Wang X, Phan TG, Ren X, Ma HH, Li Q, Ouyang M, Delcourt C, Chen X, Wang J, Robinson TG, Arima H, Ma L, Hu X, You C, Liu L, Venturelli PM, Martins SC, Pontes-Neto OM, Chalmers JP, Song L, Qureshi AI, Anderson C. Systolic Blood Pressure Trajectory and Outcomes in Acute Intracerebral Hemorrhage: Pooled Analysis of the 4 INTERACT and ATACH-II Clinical Trials. Neurology. 2026 Apr 14;106(7):e214671. doi: 10.1212/WNL.0000000000214671. Epub 2026 Mar 19. | |
| 40541207 |
Not provided
Not provided
Data will be shared with bona fide researchers after 1 year following conclusion of the study, based on a submitted protocol to the research office of The George Institute for Global Health, Sydney Australia
1 year after conclusion of the study
genuine researcher with supporting institution protocol review and approval by the research office of The George Institute
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C015568 | urapidil |
Not provided
Not provided
Not provided
central randomization with stratification
Not provided
Not provided
Outcome assessor is independent of the treatment team
|
|
reperfusion treatment (thrombolysis/thrombectomy) related symptomatic intracerebral number of cases of intracranial hemorrhage, according to standard definitions
| Day 7 |
| size of cerebral infarction | overall size of cerebral infarction on MRI within 2 days in cases of ischaemic stroke | Day 2 |
| number of patients who receive reperfusion treatment | total number of cases of reperfusion (thrombolysis and/or thrombectomy) in ischemic stroke | Day 0 |
| time to use of reperfusion treatment | time from symptom onset to reperfusion treatment in patients with ischemic stroke | Day 0 |
| size of hematoma volume | change in volume of hematoma from baseline to 24 hours, measured on brain imaging | Day 1 |
| size of hematoma volume | volume of hematoma at baseline measured on brain imaging | Day 0 |
| 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 |
| Death | Day 90 |
| 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 |
| death or dependency measured by a shift in NIHSS | day 1 and day 7 |
| Health related quality of life | according to the EQ-5D | day 90 |
| Shanghai |
| Shanghai Municipality |
| 200123 |
| China |
| Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China | Chengdu | Sichuan | 610000 | China |
| The First Affliated Hospital of Chengdu Medical College | Chengdu | Sichuan | 610500 | China |
| Derived |
| Wang X, Ren X, Li Q, Ouyang M, Chen C, Delcourt C, Chen X, Wang J, Robinson T, Arima H, Ma L, Hu X, You C, Li G, Jie Y, Lin Y, Billot L, Munoz-Venturelli P, Martins S, Pontes-Neto OM, Liu L, Chalmers J, Carcel C, Song L, Anderson CS; INTERACT Investigators. Effects of blood pressure lowering in relation to time in acute intracerebral haemorrhage: a pooled analysis of the four INTERACT trials. Lancet Neurol. 2025 Jul;24(7):571-579. doi: 10.1016/S1474-4422(25)00160-7. |
| 38752650 | Derived | Li G, Lin Y, Yang J, Anderson CS, Chen C, Liu F, Billot L, Li Q, Chen X, Liu X, Ren X, Zhang C, Xu P, Wu L, Wang F, Qiu D, Jiang M, Peng Y, Li C, Huang Y, Zhao X, Liang J, Wang Y, Wu X, Xu X, Chen G, Huang D, Zhang Y, Zuo L, Ma G, Yang Y, Hao J, Xu X, Xiong X, Tang Y, Guo Y, Yu J, Li S, He S, Mao F, Tan Q, Tan S, Yu N, Xu R, Sun M, Li B, Guo J, Liu L, Liu H, Ouyang M, Si L, Arima H, Bath PM, Ford GA, Robinson T, Sandset EC, Saver JL, Sprigg N, van der Worp HB, Song L; INTERACT4 investigators; INTERACT4 Investigators. Intensive Ambulance-Delivered Blood-Pressure Reduction in Hyperacute Stroke. N Engl J Med. 2024 May 30;390(20):1862-1872. doi: 10.1056/NEJMoa2314741. Epub 2024 May 16. |
| 38124205 | Derived | Chen C, Lin Y, Liu F, Chen X, Billot L, Li Q, Guo Y, Liu H, Si L, Ouyang M, Zhang C, Arima H, Bath PM, Ford GA, Robinson T, Sandset EC, Saver JL, Sprigg N, van der Worp HB, Liu G, Song L, Yang J, Li G, Anderson CS; INTERACT4 Investigators. Update on the INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): progress and baseline features in 2053 participants. Trials. 2023 Dec 20;24(1):817. doi: 10.1186/s13063-023-07861-5. |
| 34872617 | Derived | Song L, Chen C, Chen X, Guo Y, Liu F, Lin Y, Billot L, Li Q, Liu H, Si L, Ouyang M, Arima H, Bath PM, Ford GA, Robinson T, Sandset EC, Saver JL, Sprigg N, van der Worp HB, Zhang C, Yang J, Li G, Anderson CS; INTERACT4 investigators. INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): study protocol for a randomized controlled trial. Trials. 2021 Dec 6;22(1):885. doi: 10.1186/s13063-021-05860-y. |
| D002318 | Cardiovascular Diseases |