NCT05779215

Brief Summary

This study is designed to observe the treatment options in real-world clinical practice as well as the safety and efficacy of different treatment strategies.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
81mo left

Started Apr 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Apr 2023Dec 2032

First Submitted

Initial submission to the registry

March 7, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2032

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2032

Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

9 years

First QC Date

March 7, 2023

Last Update Submit

May 28, 2024

Conditions

Keywords

acute ischemic strokelarge vessel occlusionmedium vessel occlusionreal-world registry

Outcome Measures

Primary Outcomes (1)

  • modified Rankin Scale (mRS) score

    Ordinal distribution of mRS at 90±7 days; modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

    90±7 days

Secondary Outcomes (11)

  • Excellent functional outcome

    90±7 days

  • Good functional outcome

    90±7 days

  • mRS 0-3

    90±7 days

  • Change of National Institutes of Health Stroke Scale (NIHSS)

    24 hours

  • Change of National Institutes of Health Stroke Scale (NIHSS)

    7 days

  • +6 more secondary outcomes

Other Outcomes (5)

  • Incidence of clinically significant intracranial hemorrhage

    36 hours

  • Incidence of any intracranial hemorrhage

    36 hours

  • All-cause mortality

    90±7 days

  • +2 more other outcomes

Study Arms (1)

acute ischemic stroke with large- or medium-vessel occlusion

acute ischemic stroke patients with large- or medium-vessel occlusion including all treatments.

Other: Visit at D90

Interventions

Visits at 90±7 days after stroke onset were conducted by trained and blinded investigators, with face-to-face, telephone call or Internet access.

acute ischemic stroke with large- or medium-vessel occlusion

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute ischemic stroke due to large- or medium-vessel occlusion will be enrolled and no additional exclusion criteria are set.

You may qualify if:

  • The clinical diagnosis is acute ischemic stroke with large- or medium- vessel occlusion (the criteria followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018)
  • Informed consent from the patient or surrogate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Junwei Hao, MD; PhD

CONTACT

Gaoting Ma, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Neurology Department

Study Record Dates

First Submitted

March 7, 2023

First Posted

March 22, 2023

Study Start

April 25, 2023

Primary Completion (Estimated)

April 30, 2032

Study Completion (Estimated)

December 30, 2032

Last Updated

May 30, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations