StrokePhase 2EAST-BPNCT07279259
Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure Management
A Phase 2 study testing Adjusted BP management group and Usual BP management group in people with Stroke and Acute Ischemic Stroke, run by Shanghai East Hospital at 1 site in China.
Trial summary
This study is a Phase II, exploratory, prospective, multicenter, open-label, randomized controlled clinical trial with blinded endpoint assessment setting on the safety of an adjusted versus a conventional blood pressure management strategy during intravenous thrombolysis in AIS patients, with a key focus on the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Acute Ischemic Stroke, Thrombolysis
- What is being tested?
- Adjusted BP management group and Usual BP management group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2026to 5 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years (inclusive);
- Patients with acute ischemic stroke;
- Planned to receive intravenous thrombolysis within 4.5 hours of onset;
- Elevated blood pressure: Before receiving intravenous thrombolysis treatment, blood pressure is elevated: systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg (defined as two consecutive measurements within 2 minutes);
- Informed consent signed (or signed by a proxy).
Who cannot join
- Intracranial hemorrhage is indicated on CT or MRI (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural or epidural hematoma).
- History of intracranial hemorrhage; severe head trauma or stroke within the last 3 months.
- Intracranial tumors, giant intracranial aneurysms.
- Intracranial or spinal surgery within the last 3 months; major surgery within the last 2 weeks; arterial puncture at a site not easily compressed for hemostasis within the last 7 days.
- Gastrointestinal or urinary system bleeding within the last 3 weeks.
- Aortic dissection.
Show all 18Show fewer
- Acute bleeding tendency, including platelet count < 100×10^9/L or other bleeding tendencies.
- Received low-molecular-weight heparin orally within 24 hours; taking warfarin with INR > 1.7 or PT > 15 seconds; used a new oral anticoagulant within 48 hours.
- Blood glucose < 2.8 mmol/L or > 22.2 mmol/L.
- Large area cerebral infarction indicated on head CT or MRI (infarction area > 1/3 of the middle cerebral artery territory).
- Active visceral hemorrhage, known bleeding diathesis or significant bleeding disorders within the past 6 months
- Severe ischemic stroke (NIHSS score > 25)
- Epileptic seizures at the time of stroke onset
- Pregnant or lactating women
- Various terminal diseases with an expected survival of ≤ 3 months
- Any other physical conditions where the doctor deems participation in this study may be detrimental to the patient
- Currently participating in other drug or device clinical trials
- mRS score > 2 before onset of the disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai
Gang Li, +86 021-38804518, ligang@tongji.edu.cn
About this study
Official title: Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure Management, EAST-BP
This study is a Phase II, exploratory, prospective, multicenter, open-label, randomized controlled clinical trial with blinded endpoint assessment setting on the safety of an adjusted versus a conventional blood pressure management strategy during intravenous thrombolysis in AIS patients, with a key focus on the incidence of symptomatic intracranial hemorrhage (sICH).
Read the detailed description
This study is a Phase II, exploratory, prospective, multicenter, open-label, randomized controlled clinical trial with blinded endpoint assessment. EAST-BP aims to investigate the safety of an adjusted versus a conventional blood pressure management strategy during intravenous thrombolysis in AIS patients, according to an ordinal analysis of Proportion of symptomatic intracranial hemorrhage within 24 hours after thrombolysis, proportion of severe or life-threatening major hemorrhage, DNT time for intravenous thrombolysis patients, proportion of independent functional prognosis at 90 days (90-day mRS 0-2), sequential analysis of improved 90-day mRS score for patients, proportion of death at 90 days, and neurological function status at 7 days or at discharge (if hospital stay is less than 7 days) .
- Conditions
- Stroke, Acute Ischemic Stroke, Thrombolysis
- Being tested
- Adjusted BP management group, Usual BP management group
- Keywords
- acute ischemic stroke, blood pressure, thrombolysis
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjusted BP management groupProcedure or surgery
For patients intended to receive intravenous thrombolysis, when the blood pressure ranges from 180/100 mmHg to 200/110 mmHg, simultaneous initiation of both intravenous thrombolysis and antihypertensive treatment can be considered. If the blood pressure exceeds 200/110 mmHg, antihypertensive treatment should be initiated first. Intravenous thrombolysis can be commenced after the blood pressure is reduced to below 200/110 mmHg. Before thrombolysis and within 24 hours after the initiation of intravenous thrombolysis, efforts should be made to control the extent of blood pressure reduction. When the blood pressure drops below 180/100 mmHg, antihypertensive treatment should be terminated. Twenty-four hours later, the routine blood pressure management protocol should be reinstated.
Usual BP management groupProcedure or surgery
To receive blood pressure management according to standard local guidelines. In China, for patients scheduled for intravenous thrombolysis who present with elevated blood pressure, it is advised to maintain blood pressure below 180/100 mmHg for 24 hours, after which standard guideline-based blood pressure management should be resumed.
| Study group | Role | What they receive |
|---|---|---|
| Usual BP management group | Other | Not described Receives: Procedure: Usual BP management group |
| Adjusted BP management group | Experimental | Not described Receives: Procedure: Adjusted BP management group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of symptomatic intracranial hemorrhage
The proportion of symptomatic intracranial hemorrhage within 24 hours after thrombolysis according to ECASS III criteria
Measured: Day 1
Secondary outcomes (11)
The proportion of symptomatic intracranial hemorrhage within 24 hours
The proportion of symptomatic intracranial hemorrhage within 24 hours after thrombolysis (ECASS II criteria, SIST-MOST criteria, NINDS criteria)
Measured: DAY 1
The proportion of intracranial hemorrhage transformation
The proportion of any intracranial hemorrhage transformation within 24 hours after thrombolysis
Measured: Day 1
The proportion of major substantive hemorrhage
Measured: The proportion of major substantive hemorrhage occurring within 24 hours after thrombolysis (PH2)
The proportion of severe or life-threatening major hemorrhage
The proportion of severe or life-threatening major bleeding (as defined by GUSTO)
Measured: DAY 90
time to use of reperfusion treatment
Door-to-needle time for intravenous thrombolysis patients
Measured: DAY 1
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.
Measured: DAY 90
death or dependency measured by a shift in mRS
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.
Measured: DAY 90
Death
Measured: DAY 90
Neurological function measured by NIHSS
NIHSS score at 7 days or at discharge (if the length of hospital stay is less than 7 days)
Measured: day 7 or at discharge
Neurological function measured by mRS
mRS score at 7 days or at discharge (if the length of hospital stay is less than 7 days)
Measured: DAY 7 or at discharge
number of patients with serious adverse events
total number of serious adverse events reported during follow-up, according to standard definitions
Measured: DAY 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start15 Jan 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion5 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- central randomization with stratification
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 7th People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279259
- Sponsor's protocol ID
- EAST-BP
- Acronym
- EAST-BP
- Status last verified
- Aug 2025
- First submitted
- 18 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with bona fide researchers after 1 year following conclusion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure Management, EAST-BP
- ClinicalTrials.gov ID
- NCT07279259
- Acronym / sponsor ID
- EAST-BP / EAST-BP
- Conditions
- Stroke, Acute Ischemic Stroke, Thrombolysis
- Keywords
- acute ischemic stroke, blood pressure, thrombolysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Collaborators
- Shanghai 7th People's Hospital
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 5 Aug 2028 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase II, exploratory, prospective, multicenter, open-label, randomized controlled clinical trial with blinded endpoint assessment setting on the safety of an adjusted versus a conventional blood pressure management strategy during intravenous thrombolysis in AIS patients, with a key focus on the incidence of symptomatic intracranial hemorrhage (sICH).
Detailed description
This study is a Phase II, exploratory, prospective, multicenter, open-label, randomized controlled clinical trial with blinded endpoint assessment. EAST-BP aims to investigate the safety of an adjusted versus a conventional blood pressure management strategy during intravenous thrombolysis in AIS patients, according to an ordinal analysis of Proportion of symptomatic intracranial hemorrhage within 24 hours after thrombolysis, proportion of severe or life-threatening major hemorrhage, DNT time for intravenous thrombolysis patients, proportion of independent functional prognosis at 90 days (90-day mRS 0-2), sequential analysis of improved 90-day mRS score for patients, proportion of death at 90 days, and neurological function status at 7 days or at discharge (if hospital stay is less than 7 days) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- central randomization with stratification
| Arm | Type | Receives |
|---|---|---|
| Usual BP management group | Other | Procedure: Usual BP management group |
| Adjusted BP management group | Experimental | Procedure: Adjusted BP management group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 80 years (inclusive);
- Patients with acute ischemic stroke;
- Planned to receive intravenous thrombolysis within 4.5 hours of onset;
- Elevated blood pressure: Before receiving intravenous thrombolysis treatment, blood pressure is elevated: systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg (defined as two consecutive measurements within 2 minutes);
- Informed consent signed (or signed by a proxy).
Key exclusion criteria (18 listed)
- Intracranial hemorrhage is indicated on CT or MRI (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural or epidural hematoma).
- History of intracranial hemorrhage; severe head trauma or stroke within the last 3 months.
- Intracranial tumors, giant intracranial aneurysms.
- Intracranial or spinal surgery within the last 3 months; major surgery within the last 2 weeks; arterial puncture at a site not easily compressed for hemostasis within the last 7 days.
- Gastrointestinal or urinary system bleeding within the last 3 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjusted BP management groupFor patients intended to receive intravenous thrombolysis, when the blood pressure ranges from 180/100 mmHg to 200/110 mmHg, simultaneous initiation of both intravenous thrombolysis and antihypertensive treatment can be considered. If the blood pressure exceeds 200/110 mmHg, antihypertensive treatment should be initiated first. Intravenous thrombolysis can be commenced after the blood pressure is reduced to below 200/110 mmHg. Before thrombolysis and within 24 hours after the initiation of intravenous thrombolysis, efforts should be made to control the extent of blood pressure reduction. When the blood pressure drops below 180/100 mmHg, antihypertensive treatment should be terminated. Twenty-four hours later, the routine blood pressure management protocol should be reinstated. | Procedure or surgery | Adjusted BP management group |
| Usual BP management groupTo receive blood pressure management according to standard local guidelines. In China, for patients scheduled for intravenous thrombolysis who present with elevated blood pressure, it is advised to maintain blood pressure below 180/100 mmHg for 24 hours, after which standard guideline-based blood pressure management should be resumed. | Procedure or surgery | Usual BP management group |
Primary outcome
The proportion of symptomatic intracranial hemorrhage
Time frame: Day 1
The proportion of symptomatic intracranial hemorrhage within 24 hours after thrombolysis according to ECASS III criteria
11 secondary outcomes
The proportion of symptomatic intracranial hemorrhage within 24 hours
Time frame: DAY 1
The proportion of intracranial hemorrhage transformation
Time frame: Day 1
The proportion of major substantive hemorrhage
Time frame: The proportion of major substantive hemorrhage occurring within 24 hours after thrombolysis (PH2)
The proportion of severe or life-threatening major hemorrhage
Time frame: DAY 90
time to use of reperfusion treatment
Time frame: DAY 1
level of physical function
Time frame: DAY 90
death or dependency measured by a shift in mRS
Time frame: DAY 90
Death
Time frame: DAY 90
Neurological function measured by NIHSS
Time frame: day 7 or at discharge
Neurological function measured by mRS
Time frame: DAY 7 or at discharge
number of patients with serious adverse events
Time frame: DAY 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. Data will be shared with bona fide researchers after 1 year following conclusion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adjusted BP management group and Usual BP management group in people with Stroke and Acute Ischemic Stroke, run by Shanghai East Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gang Li (+86 021-38804518, ligang@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of symptomatic intracranial hemorrhage (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.