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StrokePhase 3EAGLENCT07790354

APEX-STROKE EAGLE Domain (EAGLE)

A Phase 3 study testing Early surgical bundle in people with Stroke and Intracerebra Hemorrhage, run by Fudan University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

In this domain of APEX-STROKE, participants with acute spontaneous supratentorial intracerebral haemorrhage (ICH) who meet the domain-specific eligibility criteria will be randomised to either an early surgical bundle or guideline-based standard care. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Intracerebra Hemorrhage
What is being tested?
Early surgical bundle
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
878 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

Who may be able to join

  • Age ≥ 18 years;
  • Confirmed diagnosis of spontaneous supratentorial intracerebral hemorrhage (ICH) via cerebral imaging;
  • Randomization completed within 6 hours of symptom onset (or last known normal state), with the ability to initiate MIS within 8 hours of ICH onset;
  • Hematoma volume ranging from 20 to 80 mL;
  • National Institutes of Health Stroke Scale (NIHSS) score ≥ 8;
  • Glasgow Coma Scale (GCS) score ≥ 8;
  • Provision of written informed consent (or signed by an authorized representative).

Who cannot join

  • Secondary causes of hemorrhage (e.g., structural abnormalities including arteriovenous malformations, cerebral aneurysms, tumors, trauma) or hemorrhagic transformation of acute ischemic stroke;
  • Isolated intraventricular hemorrhage, or brainstem/cerebellar hemorrhage;
  • Severe chronic kidney disease or liver failure;
  • High risk of mortality within 7 days, or poor adherence to study treatment or follow-up;
  • Severe comorbidities (e.g., cancer, chronic obstructive pulmonary disease, heart failure, significant pre-stroke disability [modified Rankin Scale (mRS) score 3-5]) that may confound outcome assessment;
  • Other conditions judged by the investigator to be unsuitable for MIS (e.g., brain herniation, etc.);
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  • Definite indications or contraindications for antihypertensive therapy of different intensities;
  • Specific contraindications to any component of the planned antihypertensive medications (e.g., patients with allergy or hypersensitivity to any ingredient);
  • Patients with contraindications to tranexamic acid (TXA), including: those allergic or hypersensitive to TXA or its excipients, patients with active thrombotic disorders, individuals with hereditary or acquired thrombophilia, patients with subarachnoid hemorrhage, and those with upper urinary tract bleeding complicated by gross hematuria, etc.;
  • Patients known at enrollment to be receiving therapeutic anticoagulation with warfarin or low-molecular-weight heparin (users of direct oral anticoagulants are eligible for inclusion and not excluded).

About this study

Official title: Early Surgical Bundle for Intracerebral Hemorrhage (EAGLE) Domain of the APEX-STROKE Adaptive Platform Trial

In this domain of APEX-STROKE, participants with acute spontaneous supratentorial intracerebral haemorrhage (ICH) who meet the domain-specific eligibility criteria will be randomised to either an early surgical bundle or guideline-based standard care. Intervention: Early minimally invasive surgery (MIS) shall be initiated within 8 hours of symptom onset; intensive systolic blood pressure control (target range: 130-140 mmHg) shall be achieved within 1 hour post-randomization and maintained for 72 hours post-randomization; tranexamic acid (TXA) hemostatic therapy: A 1-g loading dose shall be intravenously infused over 10 minutes, followed by an 8-hour continuous intravenous infusion of a 1-g maintenance dose; the entire regimen must be initiated within 30 minutes post-randomization. Control condition: All patient management shall strictly adhere to local institutional guidelines for intracerebral hemorrhage (ICH) diagnosis and treatment; MIS is recommended to be prohibited within 12 hours of symptom onset (except for emergency life-saving surgery); blood pressure management shall be conducted in accordance with local guidelines; the use of TXA is not recommended.

Being tested
Early surgical bundle, Guideline-Based Standard Care
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early surgical bundleOther

    1. Early Minimally Invasive Surgery (MIS): Minimally invasive surgery (needle aspiration/minimally invasive hematoma evacuation) shall be initiated as soon as practicable post-randomization, with a mandatory initiation window within 8 hours of symptom onset; postoperative residual hematoma volume shall be controlled to < 10 mL.
    2. Intensive Blood Pressure Management: Antihypertensive therapy shall be initiated immediately post-randomization and must be implemented preoperatively. Systolic blood pressure (SBP) shall be titrated to the target range of 130-140 mmHg within 1 hour and maintained at this target for 72 hours post-randomization (sustained throughout the entire perioperative period).
    3. Hemostatic Therapy: Tranexamic acid (TXA) shall be administered immediately post-randomization: a loading dose of 1 g diluted in 100 mL of fluid, infused intravenously over 10 minutes; followed by a continuous intravenous infusion of 1 g in 250 mL of fluid over 8 hours.

  • Guideline-Based Standard CareOther

    Guideline-based standard care for acute intracerebral haemorrhage is provided according to local institutional guidelines. Treatment decisions, including monitoring, blood pressure management, neurosurgical intervention, vasoactive support, mechanical ventilation, fluid therapy, and other supportive care, are determined by the treating clinical team. TXA should be avoided. If surgery is clinically required, it should generally be initiated ≥12 hours after ICH symptom onset unless emergency life-saving surgery is necessary.

Study groups in NCT07790354
Study groupRoleWhat they receive
Experimental: Early Surgical BundleExperimentalParticipants in this arm receive an early surgical bundle consisting of minimally invasive surgery (MIS), intensive blood pressure management, and tranexamic acid (TXA) haemostatic therapy, in addition to guideline-based standard care for acute spontaneous supratentorial intracerebral haemorrhage.
Receives: Other: Early surgical bundle
Active Comparator: Guideline-Based Standard CareActive comparatorParticipants in this arm receive guideline-based standard care for acute spontaneous supratentorial intracerebral haemorrhage. Clinical assessment, investigations, monitoring, blood pressure management, surgical decisions, and supportive treatment are determined by the treating clinical team according to local institutional guidelines. TXA should be avoided. If surgery is required, it should generally be initiated ≥12 hours after ICH symptom onset unless emergency life-saving surgery is clinically necessary. Surgery is not recommended for participants with a haematoma volume of 20-30 mL.
Receives: Other: Guideline-Based Standard Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Utility-Weighted Modified Rankin Scale (UW-mRS) Score at 6 Months

    Functional outcome will be assessed using the utility-weighted modified Rankin Scale (UW-mRS) by a trained central assessor blinded to treatment allocation. The UW-mRS incorporates the functional health states represented by the modified Rankin Scale into a utility-weighted measure of overall functional outcome.

    Measured: 180 days

Secondary outcomes (6)

  1. National Institutes of Health Stroke Scale (NIHSS) Score

    Neurological impairment will be assessed using the National Institutes of Health Stroke Scale (NIHSS). Higher scores indicate greater neurological impairment.

    Measured: 24 hours after randomization, 7 days after randomization or earlier at hospital discharge

  2. Rebleeding

    The occurrence of rebleeding will be assessed during the early post-randomization period. The outcome will be reported as the number and proportion of participants experiencing a rebleeding event.

    Measured: Within 7 days after randomization or earlier at hospital discharge

  3. Poor Functional Outcome

    Poor functional outcome will be defined as a modified Rankin Scale (mRS) score of 3-6. The outcome will be reported as the number and proportion of participants with mRS scores of 3-6.

    Measured: 180 days

  4. Mortality

    Mortality will be assessed as the number and proportion of participants who have died from any cause during follow-up.

    Measured: 180 days

  5. Disability

    Disability will be defined as a modified Rankin Scale (mRS) score of 3-5 and will be reported as the number and proportion of participants meeting this criterion.

    Measured: 180 days

  6. Health-Related Quality of Life Assessed by EQ-5D-5L

    Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).

    Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion28 Feb 2030 (estimated)

Resources

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
Outcomes assessor
Enrolment
878 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07790354
Sponsor's protocol ID
APEX-STROKE_EAGLE DOMAIN
Acronym
EAGLE
Status last verified
Aug 2026
First submitted
24 Aug 2026
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Early surgical bundle in people with Stroke and Intracerebra Hemorrhage, 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?

The sponsor lists 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 27 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?

Utility-Weighted Modified Rankin Scale (UW-mRS) Score at 6 Months (time frame: 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07790354.

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 27 Aug 2026.

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