StrokePhase 3NCT07784569
APEX-STROKE Adaptive Platform Trial for Stroke
A Phase 3 study testing Early Angong Niuhuang Pill Treatment, Yiqi Huayu Jiedu Mixture and Surgical bundle in people with Stroke, run by Fudan University.
Trial summary
Stroke remains one of the leading causes of death and disability, worldwide. Despite advances in stroke management, only a limited number of acute treatments-including thrombolysis, endovascular thrombectomy, hemicraniectomy, stroke unit care, and aspirin-have demonstrated clear benefit, highlighting the need for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Early Angong Niuhuang Pill Treatment, Yiqi Huayu Jiedu Mixture and Surgical bundle
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 28 Feb 2030
- Phase
- Phase 3
- 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
Platform Inclusion Criteria:
- Age ≥18 years
- Clinical diagnosis of stroke
Platform Exclusion Criteria
- There are no platform level exclusion criteria
Each state and domain will specify additional inclusion and exclusion criteria in the respective Domain-Specific Registration. Patients who fulfill the overall platform criteria will be assessed for enrollment into each active domain.
About this study
Official title: Integrated Adaptive Platform for EXcellent Clinical Trials in STROKE (APEX-STROKE): A Multi-factorial, Multi-arm, Multi-stage, Randomized, Adaptive Platform Trial
Stroke remains one of the leading causes of death and disability, worldwide. Despite advances in stroke management, only a limited number of acute treatments-including thrombolysis, endovascular thrombectomy, hemicraniectomy, stroke unit care, and aspirin-have demonstrated clear benefit, highlighting the need for widely applicable interventions that improve outcomes. Although randomized controlled trials remain the most reliable method for evaluating treatment efficacy, conventional designs typically assess a single intervention under fixed assumptions and are often costly, resource-intensive, and time-consuming. Platform trials offer a more efficient alternative by enabling the simultaneous evaluation of multiple interventions and the ongoing addition or removal of treatment arms, thereby providing a promising approach to accelerate the identification of effective therapies and transform stroke clinical research. The overarching objective of APEX-STROKE is to identify the treatment/s associated with the highest chance of improving relevant patient outcomes in stroke.
Read the detailed description
Stroke is a leading cause of death and disability worldwide. According to the Global Burden of Disease (GBD) 2021 Study, there were 11.9 million incident strokes, 93.8 million stroke survivors, and 7.3 million stroke-related deaths globally in 2021, making stroke the third leading cause of death after ischemic heart disease and COVID-19. Global disability-adjusted life years (DALYs) attributable to stroke rose from 121.4 million in 1990 to 160.5 million in 2021, with more than three-quarters of this burden borne by low- and middle-income countries.
Despite this burden, only a small number of acute stroke treatments have been proven effective, including thrombolysis, endovascular thrombectomy, hemicraniectomy, stroke unit care, and aspirin. Conventional randomized controlled trials test a single intervention under fixed assumptions and are often costly, resource-intensive, and slow. Adaptive platform trials (APTs) allow multiple interventions to be evaluated simultaneously within shared infrastructure, with interventions added or removed over time, offering greater efficiency than conventional designs.
APEX-STROKE is an investigator-initiated, multi-factorial, multi-arm, multi-stage, randomized, adaptive platform trial designed to identify the treatment(s) associated with the highest chance of improving patient outcomes in stroke. The platform is structured hierarchically: a Master Protocol establishes trial-wide processes, governance, and general statistical principles common to all domains; each disease State is further defined in a State Subprotocol; and each treatment Domain within a State is defined in a Domain-Specific Appendix (DSA). Full eligibility, interventions, and outcome measures for each active domain are specified in the respective DSA.
Depending on the domain, the statistical framework may be frequentist, Bayesian, or another appropriate approach, as specified in the relevant Statistical Analysis Appendix. Where pre-specified, adaptive analyses assess whether an intervention is superior, inferior, equivalent, or futile within a domain or in specific populations, and information may be "borrowed" across strata where justified. Where interactions between interventions in different domains are considered plausible, the statistical models may evaluate such interactions. Response Adaptive Randomization (RAR) may be used, where pre-specified, to adjust allocation probabilities as data accrue. Specific interventions, subgroups, or domains may be stopped, modified, or closed to enrollment based on pre-specified decision rules reviewed by an independent Data Safety Monitoring Board.
Unlike trial designs that prohibit co-enrollment, the platform design permits assessment of synergy, competitive interference, and safety of combined treatment strategies across domains, subject to pre-specified eligibility, randomization, and analysis rules. The intention-to-treat principle will be used for all primary and adaptive analyses unless otherwise specified at domain level.
- Conditions
- Stroke
- Being tested
- Early Angong Niuhuang Pill Treatment, Yiqi Huayu Jiedu Mixture, Surgical bundle
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Angong Niuhuang Pill TreatmentDrug
Participants randomized into the intervention arm receive Angong Niuhuang Pills (ANP, 3 g/pill). The initial dose is given orally for awake patients or via route-specific methods for unconscious patients: if randomized in the ambulance, a 15 mL suspension is administered sublingually (2-2.5 mL every 10 min) with the remainder via nasogastric tube (NGT) post-admission; if randomized in the ED, the suspension is given directly via NGT when indicated. Maintenance dosing follows: one pill twice daily in week 1 and once daily in week 2 (14 days total). Suspensions are prepared by grinding one shelled pill with 15 mL room-temperature saline and must be used within 1 hour.
Yiqi Huayu Jiedu MixtureDrug
Yiqi Huayu Jiedu Mixture is a standardized traditional Chinese medicine oral liquid formulated based on the "benefiting qi, resolving stasis, and detoxifying" therapeutic principle for acute supratentorial hypertensive intracerebral hemorrhage (HICH). Each 100 mL bottle contains Red Ginseng (30 g), Notoginseng (30 g), and Raw Rhubarb (5 g), prepared under GMP standards at Guangdong Provincial Hospital of Chinese Medicine. Administration begins within 48 hours of symptom onset for a total duration of 28 days. For patients able to take oral medication: 33 mL three times daily, taken at least 30 minutes after meals (total 100 mL/day). For patients with dysphagia, insufficient oral intake, unconsciousness, or critical illness: 25 mL via nasogastric tube four times daily (every 6 hours). The formulation aims to restore vital qi, promote blood circulation without damaging healthy qi, and eliminate pathological toxins to facilitate neurological recovery in non-surgical HICH patients.
Surgical bundleProcedure or surgery
Early minimally invasive surgery (MIS) is initiated within 8 hours after symptom onset; intensive systolic blood pressure control targeting 130-140 mmHg is achieved within 1 hour post-randomisation and sustained for 7 consecutive days; tranexamic acid (TXA) haemostatic therapy: 1g loading dose infused over 10 minutes, followed by 1g maintenance dose given via 8-hour intravenous infusion, started within 30 minutes after random allocation
- Standard guideline routine care only: All patient management is determined per local institutional ICH guidelines; elective MIS is prohibited within 12 hours of symptom onset except for emergency life-saving surgery; no mandatory intensive blood pressure management or routine TXA administration is permitted
| Study group | Role | What they receive |
|---|---|---|
| Angong Niuhuang Pill domain | Experimental | This domain has a prospective, randomized, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design to determine the efficacy and safety of Angong Niuhuang Pills in participants with acute ischemic stroke whose symptom onset is within 6 hours. Receives: Drug: Early Angong Niuhuang Pill Treatment |
| EAGLE domian | Experimental | This domain has a prospective, randomized, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design to determine the efficacy of surgical bundles in participants with acute ischemic stroke whose symptom onset is within 8 hours. Receives: Procedure: Surgical bundle |
| CHAIN-2 domain | Experimental | This study employs a multicenter, prospective, randomized, double-blind clinical trial design to evaluate the safety and efficacy of Yiqi Huayu Jiedu Mixture (composed of Red Ginseng, Notoginseng, and Raw Rhubarb) in participants with acute supratentorial hypertensive intracerebral hemorrhage (HICH) who are not undergoing surgical intervention, targeting the core syndrome pattern of "deficiency-stasis-toxin" in the acute phase. Receives: Drug: Yiqi Huayu Jiedu Mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS) score
The modified Rankin Scale (mRS) is a 7-level ordered categorical scale (range: 0-6) assessing levels of disability and death after stroke, where higher scores indicate worse outcome (0 = no symptoms; 6 = death). It is not intended for use as a measure of historical functional status. It is well accepted as a standard outcome around the world in the stroke community, by patients and by regulatory authorities.
Measured: Platform level time frame:180 days in Intracerebral Hemorrhage State; 90 days for Ischemic Stroke State. Specific time frame will be included in domain-specific registration.
Secondary outcomes (4)
NIHSS score
National Institutes of Health Stroke Scale (NIHSS) score. The NIHSS is a 15-item neurological examination scale used to quantify stroke severity, ranging from 0 (no stroke symptoms) to 42 (severe stroke), with higher scores indicating worse outcome.
Measured: 24 hours and Day 7
Mortality
All-cause mortality will be reported as the number and proportion of participants who died from any cause by 180 days after randomization.
Measured: 180 days
Death or major disability
Participants achieved death or major disability if they scored 3-6 on the modified Rankin Scale (mRS), a scale ranging from 0 (no symptoms) to 6 (death), with higher scores indicating worse outcome.
Measured: 180 days
Health-Related Quality of Life
Health Related Quality of Life based on EuroQol 5 Dimension 5 Level (EQ-5D-5L).The EQ-5D-5L is a generic instrument for describing and valuing health. It is based on a descriptive system that defines health in terms of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five response categories corresponding to: no problems, slight, moderate, severe and extreme problems.
Measured: Platform level time frame: 180 days in Intracerebral Hemorrhage State; 90 days in Ischemic Stroke State. Domain specific time frame may differ (details will be included in domain-specific registration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion28 Feb 2030 (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.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Huashan Hospital, Chinese PLA General Hospital, Beijing University of Chinese Medicine, Hubei College of Traditional Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784569
- Sponsor's protocol ID
- APEX-STROKE
- Status last verified
- Aug 2026
- First submitted
- 20 Jul 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Adaptive Platform for EXcellent Clinical Trials in STROKE (APEX-STROKE): A Multi-factorial, Multi-arm, Multi-stage, Randomized, Adaptive Platform Trial
- ClinicalTrials.gov ID
- NCT07784569
- Acronym / sponsor ID
- APEX-STROKE
- Conditions
- Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Huashan Hospital, Chinese PLA General Hospital, Beijing University of Chinese Medicine, Hubei College of Traditional Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 25 Aug 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.
Stroke remains one of the leading causes of death and disability, worldwide. Despite advances in stroke management, only a limited number of acute treatments-including thrombolysis, endovascular thrombectomy, hemicraniectomy, stroke unit care, and aspirin-have demonstrated clear benefit, highlighting the need for widely applicable interventions that improve outcomes. Although randomized controlled trials remain the most reliable method for evaluating treatment efficacy, conventional designs typically assess a single intervention under fixed assumptions and are often costly, resource-intensive, and time-consuming. Platform trials offer a more efficient alternative by enabling the simultaneous evaluation of multiple interventions and the ongoing addition or removal of treatment arms, thereby providing a promising approach to accelerate the identification of effective therapies and transform stroke clinical research. The overarching objective of APEX-STROKE is to identify the treatment/s associated with the highest chance of improving relevant patient outcomes in stroke.
Detailed description
Stroke is a leading cause of death and disability worldwide. According to the Global Burden of Disease (GBD) 2021 Study, there were 11.9 million incident strokes, 93.8 million stroke survivors, and 7.3 million stroke-related deaths globally in 2021, making stroke the third leading cause of death after ischemic heart disease and COVID-19. Global disability-adjusted life years (DALYs) attributable to stroke rose from 121.4 million in 1990 to 160.5 million in 2021, with more than three-quarters of this burden borne by low- and middle-income countries.
Despite this burden, only a small number of acute stroke treatments have been proven effective, including thrombolysis, endovascular thrombectomy, hemicraniectomy, stroke unit care, and aspirin. Conventional randomized controlled trials test a single intervention under fixed assumptions and are often costly, resource-intensive, and slow. Adaptive platform trials (APTs) allow multiple interventions to be evaluated simultaneously within shared infrastructure, with interventions added or removed over time, offering greater efficiency than conventional designs.
APEX-STROKE is an investigator-initiated, multi-factorial, multi-arm, multi-stage, randomized, adaptive platform trial designed to identify the treatment(s) associated with the highest chance of improving patient outcomes in stroke. The platform is structured hierarchically: a Master Protocol establishes trial-wide processes, governance, and general statistical principles common to all domains; each disease State is further defined in a State Subprotocol; and each treatment Domain within a State is defined in a Domain-Specific Appendix (DSA). Full eligibility, interventions, and outcome measures for each active domain are specified in the respective DSA.
Depending on the domain, the statistical framework may be frequentist, Bayesian, or another appropriate approach, as specified in the relevant Statistical Analysis Appendix. Where pre-specified, adaptive analyses assess whether an intervention is superior, inferior, equivalent, or futile within a domain or in specific populations, and information may be "borrowed" across strata where justified. Where interactions between interventions in different domains are considered plausible, the statistical models may evaluate such interactions. Response Adaptive Randomization (RAR) may be used, where pre-specified, to adjust allocation probabilities as data accrue. Specific interventions, subgroups, or domains may be stopped, modified, or closed to enrollment based on pre-specified decision rules reviewed by an independent Data Safety Monitoring Board.
Unlike trial designs that prohibit co-enrollment, the platform design permits assessment of synergy, competitive interference, and safety of combined treatment strategies across domains, subject to pre-specified eligibility, randomization, and analysis rules. The intention-to-treat principle will be used for all primary and adaptive analyses unless otherwise specified at domain level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Angong Niuhuang Pill domain | Experimental | Drug: Early Angong Niuhuang Pill TreatmentThis domain has a prospective, randomized, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design to determine the efficacy and safety of Angong Niuhuang Pills in participants with acute ischemic stroke whose symptom onset is within 6 hours. |
| EAGLE domian | Experimental | Procedure: Surgical bundleThis domain has a prospective, randomized, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design to determine the efficacy of surgical bundles in participants with acute ischemic stroke whose symptom onset is within 8 hours. |
| CHAIN-2 domain | Experimental | Drug: Yiqi Huayu Jiedu MixtureThis study employs a multicenter, prospective, randomized, double-blind clinical trial design to evaluate the safety and efficacy of Yiqi Huayu Jiedu Mixture (composed of Red Ginseng, Notoginseng, and Raw Rhubarb) in participants with acute supratentorial hypertensive intracerebral hemorrhage (HICH) who are not undergoing surgical intervention, targeting the core syndrome pattern of "deficiency-stasis-toxin" in the acute phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Early Angong Niuhuang Pill TreatmentParticipants randomized into the intervention arm receive Angong Niuhuang Pills (ANP, 3 g/pill). The initial dose is given orally for awake patients or via route-specific methods for unconscious patients: if randomized in the ambulance, a 15 mL suspension is administered sublingually (2-2.5 mL every 10 min) with the remainder via nasogastric tube (NGT) post-admission; if randomized in the ED, the suspension is given directly via NGT when indicated. Maintenance dosing follows: one pill twice daily in week 1 and once daily in week 2 (14 days total). Suspensions are prepared by grinding one shelled pill with 15 mL room-temperature saline and must be used within 1 hour. | Drug | Angong Niuhuang Pill domain |
| Yiqi Huayu Jiedu MixtureYiqi Huayu Jiedu Mixture is a standardized traditional Chinese medicine oral liquid formulated based on the "benefiting qi, resolving stasis, and detoxifying" therapeutic principle for acute supratentorial hypertensive intracerebral hemorrhage (HICH). Each 100 mL bottle contains Red Ginseng (30 g), Notoginseng (30 g), and Raw Rhubarb (5 g), prepared under GMP standards at Guangdong Provincial Hospital of Chinese Medicine. Administration begins within 48 hours of symptom onset for a total duration of 28 days. For patients able to take oral medication: 33 mL three times daily, taken at least 30 minutes after meals (total 100 mL/day). For patients with dysphagia, insufficient oral intake, unconsciousness, or critical illness: 25 mL via nasogastric tube four times daily (every 6 hours). The formulation aims to restore vital qi, promote blood circulation without damaging healthy qi, and eliminate pathological toxins to facilitate neurological recovery in non-surgical HICH patients. | Drug | CHAIN-2 domain |
| Surgical bundleEarly minimally invasive surgery (MIS) is initiated within 8 hours after symptom onset; intensive systolic blood pressure control targeting 130-140 mmHg is achieved within 1 hour post-randomisation and sustained for 7 consecutive days; tranexamic acid (TXA) haemostatic therapy: 1g loading dose infused over 10 minutes, followed by 1g maintenance dose given via 8-hour intravenous infusion, started within 30 minutes after random allocation • Standard guideline routine care only: All patient management is determined per local institutional ICH guidelines; elective MIS is prohibited within 12 hours of symptom onset except for emergency life-saving surgery; no mandatory intensive blood pressure management or routine TXA administration is permitted | Procedure or surgery | EAGLE domian |
Primary outcome
Modified Rankin Scale (mRS) score
Time frame: Platform level time frame:180 days in Intracerebral Hemorrhage State; 90 days for Ischemic Stroke State. Specific time frame will be included in domain-specific registration.
The modified Rankin Scale (mRS) is a 7-level ordered categorical scale (range: 0-6) assessing levels of disability and death after stroke, where higher scores indicate worse outcome (0 = no symptoms; 6 = death). It is not intended for use as a measure of historical functional status. It is well accepted as a standard outcome around the world in the stroke community, by patients and by regulatory authorities.
4 secondary outcomes
NIHSS score
Time frame: 24 hours and Day 7
Mortality
Time frame: 180 days
Death or major disability
Time frame: 180 days
Health-Related Quality of Life
Time frame: Platform level time frame: 180 days in Intracerebral Hemorrhage State; 90 days in Ischemic Stroke State. Domain specific time frame may differ (details will be included in domain-specific registration)
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 25 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Early Angong Niuhuang Pill Treatment, Yiqi Huayu Jiedu Mixture and Surgical bundle in people with Stroke, run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) score (time frame: Platform level time frame:180 days in Intracerebral Hemorrhage State; 90 days for Ischemic Stroke State. Specific time frame will be included in domain-specific registration.). 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 25 Aug 2026.