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

Stroke Clinical Trial

Official title:

1-year Clinical Outcomes After Intravenous Rt-PA for Chinese AIS Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05395338
• Other study ID #: 0135-0350
• Status: Completed
• Start date: April 12, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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-PA) within 4.5 hours of symptom onset compared with those who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment in a real-world clinical setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11700
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• rt-PA
Recombinant Tissue Plasminogen Activator

Locations

Country	Name	City	State
China	Boehringer Ingelheim (China) Investment Co., ltd.	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality at 1 year (modified Rankin Scale (mRS) score =6)	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.; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Dead.	up to 1 year
Secondary	mRS score 0-2 at 1 year		up to 1 year
Secondary	mRS score 0-1 at 1 year		up to 1 year
Secondary	mRS score 5-6 at 1 year		up to 1 year
Secondary	Distribution of mRS score at 1 year		up to 1 year

External Links

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