APEX-STROKE Adaptive Platform Trial for Stroke

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

Interventions

DRUG

Early Angong Niuhuang Pill Treatment

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.

DRUG

Yiqi Huayu Jiedu Mixture

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.

PROCEDURE

Surgical bundle

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

Sponsors & Collaborators

• Huashan Hospital

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• Beijing University of Chinese Medicine

  collaborator OTHER

• Hubei College of Traditional Chinese Medicine

  collaborator OTHER

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Fudan University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2029-06-30

Completion

2030-02-28