APEX-STROKE Adaptive Platform Trial for Stroke

NCT07784569 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: APEX-STROKE
• Study Type: interventional
• Target: 20,000
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  24 hours and Day 7

• Mortality

  180 days

• Death or major disability

  180 days

• Health-Related Quality of Life

  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)

Study Arms (3)

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.

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.

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.

Drug: Yiqi Huayu Jiedu Mixture

Interventions

Early Angong Niuhuang Pill Treatment DRUG

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.

Angong Niuhuang Pill domain

Yiqi Huayu Jiedu Mixture DRUG

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.

CHAIN-2 domain

Surgical bundle PROCEDURE

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

EAGLE domian

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
• Clinical diagnosis of stroke

Sponsors & Collaborators

• Fudan University: lead
• Chinese PLA General Hospital: collaborator
• Hubei College of Traditional Chinese Medicine: collaborator
• Huashan Hospital: collaborator
• Beijing University of Chinese Medicine: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator

MeSH Terms

Conditions

Stroke

Interventions

Therapeutics

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: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): February 28, 2030
• Last Updated: August 25, 2026

Record last verified: 2026-08