Acute Ischemic StrokeNCT07318948
BALANCE Trial Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
A study testing Concurrent Thrombolysis in people with Acute Ischemic Stroke, run by Bo Wu at 2 sites in China.
Trial summary
Elevated blood pressure (BP) is nearly universal in acute ischemic stroke (AIS) and critically influences eligibility for intravenous thrombolysis; however, current guidelines-requiring BP reduction to below 185/110 mmHg before treatment-lack robust evidence and may delay reperfusion in a time-sensitive therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Concurrent Thrombolysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 2 sitesChina
- Study dates
- 9 Apr 2026to 30 Sep 2028
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Clinical diagnosis of acute ischemic stroke with a clearly defined time of symptom onset or last known well, allowing for randomization within 4.5 hours.
- The treating physician has made the decision to treat the patient with intravenous thrombolysis.
- Elevated blood pressure, defined as: Pre-thrombolysis BP exceeds guideline-recommended range (e.g. China: 180/100 mmHg; U.S./Canada/Europe: 185/110 mmHg), but below 220 mmHg.
- The qualifying blood pressure must be confirmed by two separate measurements taken at least one minute apart from the same arm, using an appropriately sized cuff while the patient is in a supine or semi-recumbent position.
- Informed consent is obtained from the patient or a legally authorized representative in accordance with local regulations. A deferred or waiver of consent model will be used where permitted by local ethics committees for emergency research.
Who cannot join
- Any condition that, in the judgment of the investigator, would preclude follow-up or interfere with outcome assessment (e.g., end-stage malignancy, severe multi-organ failure).
- The patient is pregnant or breastfeeding.
- Concurrent enrollment in another interventional trial where the intervention is likely to confound the study endpoints.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610000
Bo Wu, Doctor, 18980602142, dr.bowu@hotmail.com
- Not yet recruiting
Bo Wu
Chengdu, Sichuan, 610041
Bo Wu, +8618980602142, dr.bowu@hotmail.com
Tianxiang Lan, +8618181551016, odbluetx@gmail.com
About this study
Official title: BALANCE Trial Protocol - Blood Pressure Lowering and Thrombolysis: Concurrent vs Sequential Management in Acute Ischemic Stroke
Elevated blood pressure (BP) is nearly universal in acute ischemic stroke (AIS) and critically influences eligibility for intravenous thrombolysis; however, current guidelines-requiring BP reduction to below 185/110 mmHg before treatment-lack robust evidence and may delay reperfusion in a time-sensitive therapy, potentially worsening outcomes. Emerging data suggest that aggressive pre-thrombolysis BP lowering does not reduce hemorrhage risk and might impair recovery, highlighting the need to avoid large BP fluctuations. Yet it remains uncertain whether initiating thrombolysis concurrently with antihypertensive therapy is safer and more effective than the standard sequential approach, particularly in patients with markedly elevated but not extreme BP (systolic <220 mmHg).
To address this gap, the BALANCE trial is a prospective, multicenter, randomized controlled study enrolling AIS patients within 4.5 hours of onset whose pre-thrombolysis BP exceeds regional guideline thresholds (e.g., >180/100 mmHg in China or >185/110 mmHg internationally) but is <220 mmHg and who are otherwise eligible for thrombolysis. Patients are randomized to either: (1) concurrent management-immediate thrombolysis with simultaneous IV antihypertensive therapy to gradually lower BP-or (2) sequential management-antihypertensive treatment first, followed by thrombolysis only after BP reaches target. The primary endpoint is a hierarchical composite analyzed using the win ratio, prioritizing: (1) functional outcome (90-day mRS distribution), (2) major safety (symptomatic intracerebral hemorrhage within 7 days per SITS-MOST criteria), and (3) process efficiency (door-to-needle time).
Conducted across 80-100 global stroke centers, BALANCE aims to provide definitive evidence to optimize BP management and improve outcomes in AIS patients with elevated BP.
Read the detailed description
Hypertension is the most common physiological abnormality in patients presenting with acute ischemic stroke (AIS), and elevated blood pressure (BP) plays a critical role in determining eligibility and timing for intravenous thrombolysis.
Current international guidelines recommend lowering BP to below 185/110 mmHg before administering thrombolytic therapy, a process that requires antihypertensive treatment and inevitably delays thrombolysis. However, this recommendation lacks robust evidence. Meanwhile, because the effectiveness of thrombolysis is highly time-dependent, these BP-lowering delays may worsen clinical outcomes by prolonging door-to-needle time and delaying reperfusion.
On the other hand, recent prospective studies on blood pressure management before and after thrombolysis and thrombectomy have shown that lower BP levels do not significantly reduce the risk of hemorrhage and may lead to poorer long-term outcomes. Although these studies compared BP ranges below 180 or 185 mmHg, it remains unclear whether this pattern applies to patients with severely elevated BP. These findings suggest the importance of avoiding large and rapid BP fluctuations. Initiating thrombolysis after BP reduction could result in significant BP fluctuations and prolonged periods of low BP post-thrombolysis.
Given the lack of high-quality evidence on optimal treatment strategies for patients with pre-thrombolysis hypertension, an alternative concurrent BP management strategy has been proposed. This approach involves initiating thrombolysis and antihypertensive treatment simultaneously. By doing so, it aims to minimize treatment delays while maintaining BP control within accepted post-thrombolysis targets. However, concerns exist about whether initiating thrombolysis at higher-than-recommended BP levels increases the risk of symptomatic intracerebral hemorrhage or other complications. Consequently, substantial clinical uncertainty exists regarding which strategy-concurrent or sequential BP management-is superior for patients.
The BALANCE trial is a prospective, multicenter, randomized controlled study compare the effectiveness and safety between concurrent and sequential strategies. The concurrent strategy involves immediate initiation of intravenous thrombolysis, accompanied by simultaneous IV antihypertensive therapy to gradually lower BP during and after thrombolysis. In contrast, the sequential strategy starts with antihypertensive treatment, and thrombolysis is withheld until BP falls within guideline-recommended limits. AIS patients presenting within 4.5 hours of symptom onset with pre-thrombolysis BP exceeding guideline-recommended ranges (e.g., China: 180/100 mmHg; U.S./Canada/Europe: 185/110 mmHg) but below 220 mmHg, and who are otherwise eligible for intravenous thrombolysis, will be enrolled across 80-100 stroke centers worldwide. The primary endpoint is a hierarchical composite outcome analyzed using the win ratio method. It comprises three components, prioritized in the following order: (1) functional outcome, defined as the distribution of modified Rankin Scale (mRS) scores at 90 days after randomization; (2) major safety, defined as the occurrence of symptomatic intracerebral hemorrhage (sICH) within 7 days after randomization according to the SITS-MOST criteria; and (3) process efficiency, defined as door-to-needle time (DNT)-the interval from emergency department arrival to the start of thrombolytic infusion. In pairwise comparisons between treatment groups, a patient "wins" if they have a better outcome on the highest-priority component where a difference exists.
By evaluating these two fundamentally different management pathways, the BALANCE trial seeks to generate definitive evidence that may inform future guideline recommendations and optimize care for patients with acute ischemic stroke and elevated blood pressure.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Concurrent Thrombolysis
- Keywords
- Acute Ischemic Stroke, Thrombolysis, Blood Management
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent ThrombolysisOther
Lowering the blood pressure and undergoing thrombolysis at the same time while the partipants blood pressure is higher than 185/110 mmHg or 180/100 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Sequential Arm | No intervention | 1. Antihypertensive Therapy: Immediately after randomization, intravenous antihypertensive therapy is initiated to actively lower the patient's blood pressure to below the guideline recommended range. 2. Thrombolysis: Once the blood pressure is confirmed to be at or below the guideline recommended range, intravenous thrombolysis (alteplase or tenecteplase, per local standard of care) is administered. |
| Conccurent Arm | Experimental | 1. Thrombolysis: Immediately after randomization, intravenous thrombolysis (alteplase or tenecteplase, per local standard of care) is administered as per local practice.
2. Antihypertensive Therapy: As soon as feasible after the start of thrombolysis, intravenous antihypertensive therapy is initiated with the goal of lowering blood pressure to below guideline recommended range. (e.g. China: 180/100 mmHg; U.S./Canada/Europe: 185/110 mmHg). Receives: Other: Concurrent Thrombolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint: A Justification for the Hierarchical Win Ratio
The win ratio is a patient-centered statistical method that allows for the comparison of treatment arms across several prioritized outcomes. It provides a more holistic assessment of the net clinical benefit. The hierarchy is ordered based on clinical importance:
- Functional Outcome: Defined as the distribution in scores on the modified Rankin scale (mRS) at 90 days after randomization.
- Major Safety: Defined as the sICH occurrence within 7 days after randomization, based on SITS-MOST criteria.
Process Efficiency: Defined as the time between emergency department entry to thrombolysis start (DNT).
Measured: 90-day
Secondary outcomes (9)
Excellent Functional Outcome
The proportion of patients with an mRS score of 0-1 at 90 days.
Measured: 90-day
Good Functional Outcome
The proportion of patients with an mRS score of 0-2 at 90 days.
Measured: 90-day
Distribution of Functional Outcome
The mRS score at 90 days and the utility weighted mRS.
Measured: 90-day
Quality of Life at 90 days
Quality of Life measured using the EQ-5D-5L at 90 days.
Measured: 90-day
Neurological Status at 72 Hours
The National Institutes of Health Stroke Scale (NIHSS) score assessed between 72±12 hours post-randomization.
Measured: 72±12 hours
Early Neurological Improvement
Defined as achieving an NIHSS score of 0-1 or a decrease of ≥4 points from the baseline NIHSS score at the 72±12 hour assessment.
Measured: 72±12 hour
Mortality
All-cause mortality at 90 days.
Measured: 90-day
Malignant Cerebral Edema
The incidence of malignant edema, adjudicated by the central imaging core lab according to follow-up imaging and medical history.
Measured: 90-day
Process Metrics
DNT, the time between emergency department entry to thrombolysis start.
Measured: 24-hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start9 Apr 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Different sequences of blood pressure management and intravenous thrombolysis.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bo Wu
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, Mianyang Central Hospital, Panzhihua Central Hospital, The First People's Hospital of Ziyang, Zigong The Fourth People's Hospital, Zigong No.1 Peoples Hospital
- Responsible party
- Sponsor-investigator, Bo Wu, West China Hospital
- Investigators
- Bijoy Menon, MD, Phd, Principal investigator, University of CalgaryBo Wu, MD, PhD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318948
- Sponsor's protocol ID
- 2025(No.2280)
- Status last verified
- Aug 2026
- First submitted
- 8 Dec 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will include individual information from multicenter and multination. To protect the participants' privacy and follow the guidelines of other center or nations' ethical committee, we don't provide or share IPD with other reasearchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BALANCE Trial Protocol - Blood Pressure Lowering and Thrombolysis: Concurrent vs Sequential Management in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07318948
- Acronym / sponsor ID
- 2025(No.2280)
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Thrombolysis, Blood Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Bo WuUniversity, hospital or other
- Collaborators
- West China Hospital, Mianyang Central Hospital, Panzhihua Central Hospital, The First People's Hospital of Ziyang, Zigong The Fourth People's Hospital, Zigong No.1 Peoples Hospital
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 6 Jan 2026 (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.
Elevated blood pressure (BP) is nearly universal in acute ischemic stroke (AIS) and critically influences eligibility for intravenous thrombolysis; however, current guidelines-requiring BP reduction to below 185/110 mmHg before treatment-lack robust evidence and may delay reperfusion in a time-sensitive therapy, potentially worsening outcomes. Emerging data suggest that aggressive pre-thrombolysis BP lowering does not reduce hemorrhage risk and might impair recovery, highlighting the need to avoid large BP fluctuations. Yet it remains uncertain whether initiating thrombolysis concurrently with antihypertensive therapy is safer and more effective than the standard sequential approach, particularly in patients with markedly elevated but not extreme BP (systolic <220 mmHg).
To address this gap, the BALANCE trial is a prospective, multicenter, randomized controlled study enrolling AIS patients within 4.5 hours of onset whose pre-thrombolysis BP exceeds regional guideline thresholds (e.g., >180/100 mmHg in China or >185/110 mmHg internationally) but is <220 mmHg and who are otherwise eligible for thrombolysis. Patients are randomized to either: (1) concurrent management-immediate thrombolysis with simultaneous IV antihypertensive therapy to gradually lower BP-or (2) sequential management-antihypertensive treatment first, followed by thrombolysis only after BP reaches target. The primary endpoint is a hierarchical composite analyzed using the win ratio, prioritizing: (1) functional outcome (90-day mRS distribution), (2) major safety (symptomatic intracerebral hemorrhage within 7 days per SITS-MOST criteria), and (3) process efficiency (door-to-needle time).
Conducted across 80-100 global stroke centers, BALANCE aims to provide definitive evidence to optimize BP management and improve outcomes in AIS patients with elevated BP.
Detailed description
Hypertension is the most common physiological abnormality in patients presenting with acute ischemic stroke (AIS), and elevated blood pressure (BP) plays a critical role in determining eligibility and timing for intravenous thrombolysis.
Current international guidelines recommend lowering BP to below 185/110 mmHg before administering thrombolytic therapy, a process that requires antihypertensive treatment and inevitably delays thrombolysis. However, this recommendation lacks robust evidence. Meanwhile, because the effectiveness of thrombolysis is highly time-dependent, these BP-lowering delays may worsen clinical outcomes by prolonging door-to-needle time and delaying reperfusion.
On the other hand, recent prospective studies on blood pressure management before and after thrombolysis and thrombectomy have shown that lower BP levels do not significantly reduce the risk of hemorrhage and may lead to poorer long-term outcomes. Although these studies compared BP ranges below 180 or 185 mmHg, it remains unclear whether this pattern applies to patients with severely elevated BP. These findings suggest the importance of avoiding large and rapid BP fluctuations. Initiating thrombolysis after BP reduction could result in significant BP fluctuations and prolonged periods of low BP post-thrombolysis.
Given the lack of high-quality evidence on optimal treatment strategies for patients with pre-thrombolysis hypertension, an alternative concurrent BP management strategy has been proposed. This approach involves initiating thrombolysis and antihypertensive treatment simultaneously. By doing so, it aims to minimize treatment delays while maintaining BP control within accepted post-thrombolysis targets. However, concerns exist about whether initiating thrombolysis at higher-than-recommended BP levels increases the risk of symptomatic intracerebral hemorrhage or other complications. Consequently, substantial clinical uncertainty exists regarding which strategy-concurrent or sequential BP management-is superior for patients.
The BALANCE trial is a prospective, multicenter, randomized controlled study compare the effectiveness and safety between concurrent and sequential strategies. The concurrent strategy involves immediate initiation of intravenous thrombolysis, accompanied by simultaneous IV antihypertensive therapy to gradually lower BP during and after thrombolysis. In contrast, the sequential strategy starts with antihypertensive treatment, and thrombolysis is withheld until BP falls within guideline-recommended limits. AIS patients presenting within 4.5 hours of symptom onset with pre-thrombolysis BP exceeding guideline-recommended ranges (e.g., China: 180/100 mmHg; U.S./Canada/Europe: 185/110 mmHg) but below 220 mmHg, and who are otherwise eligible for intravenous thrombolysis, will be enrolled across 80-100 stroke centers worldwide. The primary endpoint is a hierarchical composite outcome analyzed using the win ratio method. It comprises three components, prioritized in the following order: (1) functional outcome, defined as the distribution of modified Rankin Scale (mRS) scores at 90 days after randomization; (2) major safety, defined as the occurrence of symptomatic intracerebral hemorrhage (sICH) within 7 days after randomization according to the SITS-MOST criteria; and (3) process efficiency, defined as door-to-needle time (DNT)-the interval from emergency department arrival to the start of thrombolytic infusion. In pairwise comparisons between treatment groups, a patient "wins" if they have a better outcome on the highest-priority component where a difference exists.
By evaluating these two fundamentally different management pathways, the BALANCE trial seeks to generate definitive evidence that may inform future guideline recommendations and optimize care for patients with acute ischemic stroke and elevated blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Different sequences of blood pressure management and intravenous thrombolysis.
| Arm | Type | Receives |
|---|---|---|
| Sequential Arm | No intervention | –1. Antihypertensive Therapy: Immediately after randomization, intravenous antihypertensive therapy is initiated to actively lower the patient's blood pressure to below the guideline recommended range. 2. Thrombolysis: Once the blood pressure is confirmed to be at or below the guideline recommended range, intravenous thrombolysis (alteplase or tenecteplase, per local standard of care) is administered. |
| Conccurent Arm | Experimental | Other: Concurrent Thrombolysis1. Thrombolysis: Immediately after randomization, intravenous thrombolysis (alteplase or tenecteplase, per local standard of care) is administered as per local practice. 2. Antihypertensive Therapy: As soon as feasible after the start of thrombolysis, intravenous antihypertensive therapy is initiated with the goal of lowering blood pressure to below guideline recommended range. (e.g. China: 180/100 mmHg; U.S./Canada/Europe: 185/110 mmHg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Clinical diagnosis of acute ischemic stroke with a clearly defined time of symptom onset or last known well, allowing for randomization within 4.5 hours.
- The treating physician has made the decision to treat the patient with intravenous thrombolysis.
- Elevated blood pressure, defined as: Pre-thrombolysis BP exceeds guideline-recommended range (e.g. China: 180/100 mmHg; U.S./Canada/Europe: 185/110 mmHg), but below 220 mmHg.
- The qualifying blood pressure must be confirmed by two separate measurements taken at least one minute apart from the same arm, using an appropriately sized cuff while the patient is in a supine or semi-recumbent position.
Key exclusion criteria (3 listed)
- Any condition that, in the judgment of the investigator, would preclude follow-up or interfere with outcome assessment (e.g., end-stage malignancy, severe multi-organ failure).
- The patient is pregnant or breastfeeding.
- Concurrent enrollment in another interventional trial where the intervention is likely to confound the study endpoints.
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 |
|---|---|---|
| Concurrent ThrombolysisLowering the blood pressure and undergoing thrombolysis at the same time while the partipants blood pressure is higher than 185/110 mmHg or 180/100 mmHg. | Other | Conccurent Arm |
Primary outcome
Primary Endpoint: A Justification for the Hierarchical Win Ratio
Time frame: 90-day
The win ratio is a patient-centered statistical method that allows for the comparison of treatment arms across several prioritized outcomes. It provides a more holistic assessment of the net clinical benefit. The hierarchy is ordered based on clinical importance: 1. Functional Outcome: Defined as the distribution in scores on the modified Rankin scale (mRS) at 90 days after randomization. 2. Major Safety: Defined as the sICH occurrence within 7 days after randomization, based on SITS-MOST criteria. Process Efficiency: Defined as the time between emergency department entry to thrombolysis start (DNT).
9 secondary outcomes
Excellent Functional Outcome
Time frame: 90-day
Good Functional Outcome
Time frame: 90-day
Distribution of Functional Outcome
Time frame: 90-day
Quality of Life at 90 days
Time frame: 90-day
Neurological Status at 72 Hours
Time frame: 72±12 hours
Early Neurological Improvement
Time frame: 72±12 hour
Mortality
Time frame: 90-day
Malignant Cerebral Edema
Time frame: 90-day
Process Metrics
Time frame: 24-hour
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 1 Sep 2026.
- Individual participant dataSharing planned: No. This study will include individual information from multicenter and multination. To protect the participants' privacy and follow the guidelines of other center or nations' ethical committee, we don't provide or share IPD with other reasearchers.
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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.
Bijoy Menon, MD, Phd principal investigator
University of Calgary
Bo Wu, MD, PhD principal investigator
West China Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concurrent Thrombolysis in people with Acute Ischemic Stroke, run by Bo Wu at 2 sites 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 6 inclusion and 3 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Bo Wu (+8618980602142, dr.bowu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint: A Justification for the Hierarchical Win Ratio (time frame: 90-day). 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 1 Sep 2026.