APEX-STROKE EAGLE Domain (EAGLE)

NCT07790354 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: APEX-STROKE_EAGLE DOMAIN
• Study Type: interventional
• Target: 878
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Stroke; Intracerebra Hemorrhage

Outcome Measures

Primary Outcomes (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.

  180 days

Secondary Outcomes (6)

• National Institutes of Health Stroke Scale (NIHSS) Score

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

• Rebleeding

  Within 7 days after randomization or earlier at hospital discharge

• Poor Functional Outcome

  180 days

• Mortality

  180 days

• Disability

  180 days

Study Arms (2)

Experimental: Early Surgical Bundle

EXPERIMENTAL

Participants 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.

Other: Early surgical bundle

Active Comparator: Guideline-Based Standard Care

ACTIVE COMPARATOR

Participants 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.

Other: Guideline-Based Standard Care

Interventions

Early surgical bundle OTHER

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.

Experimental: Early Surgical Bundle

Guideline-Based Standard Care OTHER

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.

Active Comparator: Guideline-Based Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.);
• 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.;

Sponsors & Collaborators

• Fudan University: lead
• Huashan Hospital: collaborator
• First Affiliated Hospital of Fujian Medical University: collaborator

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): February 28, 2030
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share