STROKE 120 ACTION Trial

Official title

STROKE 120 ACTION: a National Cluster Randomized Controlled Trial

Overview

Stroke is the main cause of death and disability in China, but it is preventable and treatable. For the most common type, acute ischemic stroke (AIS), initiating reperfusion therapy with intravenous thrombolysis (IVT) with or without mechanical thrombectomy (MT) within several hours of the onset of symptoms can significantly improve the chances of surviving free of major disability, and earlier the intervention is given the better the outcome. Thus, whether patients can achieve timely arrived at hospital, ideally within the critical 4.5-hour golden window, is pivotal to achieving high rates of recanalization and optimal functional outcome. To this end, it is important to note that the overall pre-hospital delay for patients with AIS is currently 24 hours in China. We plan to conduct STROKE 120 ACTION, a national cluster randomized controlled trial, to determine whether implementing a STROKE 120 multifaceted intervention campaign can reduce pre-hospital delay in AIS, increase the 4.5-hour hospital arrival rate, and improve survival, disability, and healthcare costs. The STROKE 120 ACTION trial will recruit 16 community units across 8 regions in China, with each region enrolling 2 community units with a residential population of at least 110,000 and comparable demographic characteristics. To avoid cross-contamination, the participating community clusters will maintain a physical distance of more than 20 kilometers. Within each region, the 2 community units will be randomly assigned at a 1:1 ratio to receive the intervention (12-month usual health policy plus STROKE 120 multifaceted intervention campaign; 3-month intensive period and 9-month maintenance period) or control (12-month usual health policy alone). The study outcomes and related data on incident AIS cases within each participating community unit will be collected after the implementation of STROKE 120 multifaceted intervention campaign (from month 1 to month 12 of multifaceted intervention campaign). The primary outcome is proportion of hospital arrival within 4.5 hours after symptom onset within participating community units. Secondary outcomes include time from onset to hospital admission, time from onset to action, use of 120 emergency ambulances, IVT, MT, total hospitalization costs, out-of-pocket costs, composite outcome of death or major disability (modified Rankin scale score \[mRS\] ≥3) at 3 months, ordinal 7-level mRS score at 3 months, all-cause mortality within 3 months. The sample size was calculated according to the following estimates: (1) a significance level of 0.05 for a 2-sided test; (2) statistical power of 85%; (3) 4.5-hour hospital arrival rate of 10% for AIS patients in control group; (4) 4.5-hour hospital arrival rate of 20% among AIS patients in intervention group; (5) intra-class correlation coefficient of 0.03; and (6) a 10% loss to follow-up. The estimated sample size is 3,312 incident AIS patients from 16 community units with an average cluster size of 207 patients per community unit. The annual incidence of AIS is 195 per 100,000 people, and the sample size of participants in each community unit will be 106,000. Thus, the total sample size of the present study will be 1,696,000 participants from 16 community units. The STROKE 120 ACTION trial will address the critical issue of long pre-hospital delay in AIS in China, and provide profound implications for global stroke prevention and control strategies.

Interventions

• Behavioral STROKE 120 multifaceted intervention campaign
  Based on the existing usual health policy, the intervention group will implement a STROKE 120 multifaceted intervention campaign in the intervention community units for a continuous period of 12 months (3-month intensive period and 9-month maintenance period). The detailed implementation plan for the STROKE 120 multifaceted intervention campaign in the intervention group is as follows: 1. Training medical workers in stroke center; 2. Training emergency center staff and primary care physicians;

Primary outcome measures

• Arriving hospital within 4.5 hours after symptom onset among incident acute ischemic stroke cases within participating community units [Time frame: From month 1 to month 12 of multifaceted intervention campaign]

Secondary outcome measures (10)

• Time from onset to hospital admission after acute ischemic stroke [Time frame: From month 1 to month 12 of multifaceted intervention campaign]
• Time from onset to action after acute ischemic stroke [Time frame: From month 1 to month 12 of multifaceted intervention campaign]
• Use of 120 emergency ambulances after acute ischemic stroke [Time frame: From month 1 to month 12 of multifaceted intervention campaign]
• Intravenous thrombolysis after acute ischemic stroke [Time frame: From month 1 to month 12 of multifaceted intervention campaign]
• Mechanical thrombectomy after acute ischemic stroke [Time frame: From month 1 to month 12 of multifaceted intervention campaign]
• Total hospitalization costs [Time frame: At Hospital Discharge after ischemic stroke onset (ischemic stroke patients occurring from month 1 to month 12 of multifaceted intervention campaign)]
• Out-of-pocket hospitalization costs [Time frame: At Hospital Discharge after ischemic stroke onset (ischemic stroke patients occurring from month 1 to month 12 of multifaceted intervention campaign)]
• Composite outcome of death or major disability at 3 months after acute ischemic stroke [Time frame: Three months after ischemic stroke (ischemic stroke patients occurring from month 1 to month 12 of multifaceted intervention campaign)]
• Ordinal 7-level modified Rankin Scale score at 3 months after acute ischemic stroke [Time frame: Three months after ischemic stroke (ischemic stroke patients occurring from month 1 to month 12 of multifaceted intervention campaign)]
• All-cause mortality within 3 months after acute ischemic stroke [Time frame: Three months after ischemic stroke (ischemic stroke patients occurring from month 1 to month 12 of multifaceted intervention campaign)]

Eligibility criteria

This trial will evaluate whether the STROKE 120 multifaceted intervention campaign can reduce the pre-hospital delay in AIS and increase the 4.5-hour arrival rate in 16 community units across 8 regions in China. We will select 2 community units from each region as the study sites and randomly divide the 2 community units within each region into the intervention group and the control group. The selection criteria for community units are listed as follows:

• The 2 participating community units in each region should each have a permanent population over 110,000 (people aged 60 years and above accounting for at least 15%), have similar demographic characteristics (e.g., age, gender, and education level), and have comparable local health policies (e.g., medical insurance policies, emergency system framework, stroke emergency map release, and stroke center quality control), economic levels, and public ability to recognize AIS.
• The participating hospitals in each community unit serve >90% of AIS patients within the community unit, have a well-established stroke center, and have comparable standardized treatment capabilities for AIS (including 4.5-hour hospital arrival rate of AIS, rate of using 120 emergency ambulances after AIS, and rate of IVT after AIS).
• The participating communities are capable of implementing STROKE 120 multifaceted intervention campaign within its community unit.
• To avoid cross-contamination, the physical distance between any two community units exceeds 20 kilometers.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

China · 1 center

• Shanghai Minhang Central Hospital — Shanghai

Identifiers

NCT: NCT07135310 · 2025-055-01K

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗