Status:

COMPLETED

1-year Clinical Outcomes in Recombinant Tissue Plasminogen Activator (Rt-PA) Treated Chinese Acute Ischaemic Stroke (AIS) Patients

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Stroke

Eligibility:

All Genders

18+ years

Brief Summary

The objective of the study is to find out the 1-year clinical outcomes among Acute Ischaemic Stroke (AIS) patients who were treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-P...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Patients registered in the ZSQCC platform from Jan 2017 to Mar 2020
  • ≥ 18 years of age
  • Diagnosed with AIS at admission
  • Arrived or admitted to the hospital within 4.5 hours of symptom onset
  • If treated with IV rt-PA: received IV rt-PA within 4.5 hours of symptom onset
  • Exclusion criteria:
  • Documented Intravenous Thrombolysis (IVT) contraindication except age to IV rt-PA treatment according to the Summary of Product Characteristics (SmPC)
  • Missing any one of the key data (age, gender, baseline National Institutes of Health Stroke Scale \[NIHSS\], time of symptom onset, time of hospital arrival or admission, IVT or not, time of IV rt-PA treatment)
  • Received thrombolysis agents other than rt-PA (urokinase, tenecteplase, recombinant plasminogen activator, prourokinase, streptokinase)
  • Received endovascular treatment
  • Received IV rt-PA after 4.5 hours of symptom onset

Exclusion

    Key Trial Info

    Start Date :

    April 12 2022

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    November 30 2022

    Estimated Enrollment :

    12551 Patients enrolled

    Trial Details

    Trial ID

    NCT05395338

    Start Date

    April 12 2022

    End Date

    November 30 2022

    Last Update

    October 16 2024

    Active Locations (1)

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    Boehringer Ingelheim (China) Investment Co., ltd.

    Shanghai, China, 200040