- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05395338
1-year Clinical Outcomes in Recombinant Tissue Plasminogen Activator (Rt-PA) Treated Chinese Acute Ischaemic Stroke (AIS) Patients
1-year Clinical Outcomes After Intravenous Rt-PA for Chinese AIS Patients
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Shanghai, China, 200040
- Boehringer Ingelheim (China) Investment Co., ltd.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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IV rt-PA cohort
Patients who received IV rt-PA within 4.5 hours of symptom onset
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Recombinant Tissue Plasminogen Activator
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Non-reperfusion cohort
Patients who arrived or were admitted to the hospital within4.5 hours of symptom onset and did not receive any reperfusion treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause mortality at 1 year (modified Rankin Scale (mRS) score =6)
Time Frame: up to 1 year
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The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. 0 - No symptoms.
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up to 1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Distribution of mRS score at 1 year
Time Frame: up to 1 year
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up to 1 year
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mRS score 0-2 at 1 year
Time Frame: up to 1 year
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up to 1 year
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mRS score 0-1 at 1 year
Time Frame: up to 1 year
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up to 1 year
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mRS score 5-6 at 1 year
Time Frame: up to 1 year
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up to 1 year
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0135-0350
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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