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Clinical Trials/NCT07419997
NCT07419997
Recruiting
Not Applicable

A Multicenter, Retrospective, Observational Cohort Study on Intravenous Thrombolysis Beyond the Time Window for Acute Ischemic Stroke

Xuanwu Hospital, Beijing1 site in 1 country2,600 target enrollmentStarted: December 29, 2025Last updated:
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Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
2,600
Locations
1
Primary Endpoint
Proportion of study participants with mRS scores of 0 - 1
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

A multicenter, retrospective, observational cohort study on intravenous thrombolysis beyond the time window for acute ischemic stroke

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with acute ischemic stroke, regardless of gender;
  • •Age ≥ 18 years old;
  • •Time from onset to treatment within 4.5 - 24 hours (the onset time refers to the last time when they appeared normal);
  • •Complete relevant clinical data (including gender, age, mRS, NIHSS, etc.).

Exclusion Criteria

  • Not provided

Arms & Interventions

Alteplase group

The research participants received Alteplase for Acute Ischemic Stroke at 4.5 to 24 Hours

Tenecteplase group

The research participants received Tenecteplase for Acute Ischemic Stroke at 4.5 to 24 Hours

Outcomes

Primary Outcomes

Proportion of study participants with mRS scores of 0 - 1

Time Frame: at 90 (±7) days

Proportion of study participants with mRS scores of 0 - 1

Secondary Outcomes

  • Distribution of mRS scores ranging from 0 to 6(at 90 (±7) days)
  • Proportion of study participants with mRS scores of 0 - 2(at 90 (±7) days)
  • The proportion of study participants with a NIHSS score of ≤1 or a decrease of ≥8 points compared to the baseline(at 24 (±12) hours)
  • mortality rate(at 90 (±7) days)
  • Symptomatic intracranial hemorrhage(within 36 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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