NCT06125236

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
8,000

participants targeted

Target at P75+ for all trials

Timeline
244mo left

Started Nov 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 Progress11%
Nov 2023May 2046

First Submitted

Initial submission to the registry

November 6, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 9, 2023

Completed
22.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2045

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2046

Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

22.1 years

First QC Date

November 6, 2023

Last Update Submit

November 9, 2023

Conditions

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)

Affiliated Hospital of Southwest Medical University

Luzhou, 646000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Thrombosis.

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Zhengzhou Yuan, MD

    Department of Neurology, Affiliated Hospital of Southwest Medical University, LuZhou, China.

    STUDY CHAIR

Central Study Contacts

Zhengzhou Yuan, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Director of Stroke Center

Study Record Dates

First Submitted

November 6, 2023

First Posted

November 9, 2023

Study Start

November 9, 2023

Primary Completion (Estimated)

December 1, 2045

Study Completion (Estimated)

May 1, 2046

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations