Temporal Trends of Thrombolysis Treatment in Chinese Acute Ischemic Stroke (AIS) Patients From 2007-2017: Analysis of China National Stroke Registry (CNSR) I, II, and III; CTP-Draft Review Performed;

NCT ID: NCT04290494

Last Updated: 2021-11-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42188 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-21
• Study Completion Date: 2020-09-30

Brief Summary

The present study is to be conducted based on the AIS patient data collected from CNSR I, II, and III.

The primary objectives are:

• To investigate the temporal changes in the proportion of intravenous recombinant plasminogen activator (IV rtPA) treatment from 2007 to 2017 among Intravenous Thrombolytics (IVT) eligible patients (patient groups B and B') and overall AIS patients (patient group A) in China;
• To investigate the temporal changes in IV rtPA treatment time intervals from 2007 to 2017 among IV rtPA treated patients (patient groups C and C') in China.

The secondary objectives are:

• To describe the demographic and clinical characteristics of the IV rtPA treated patients (patient groups C and C'), IVT eligible patients (patient groups B and B') and the overall AIS patients (patient group A) from 2007 to 2017 from the CNSR I to III.

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

CNSR I (2007 to 2008)

For this group following patients will be analysed:

The overall AIS patients aged 18 to 80 years who arrived at hospital within 7 days of symptom onset (Patient group A)

Thereof: IVT eligible patients:

AIS patients who arrived at hospital within 2 hours (patient group B) and 3.5 hours (patient group B') of symptom onset and with no documented absolute contraindications to IVT treatment

Thereof: IV rtPA treated patients:

IVT eligible patients who arrived at hospital within 2 hours of symptom onset and received IV rtPA within 3 hours of symptom onset (patient group C) and those who arrived at hospital within 3.5 hours of symptom onset and received IV rtPA within 4.5 hours of symptom onset (patient group C')

IV rtPA (intravenous recombinant plasminogen activator)

Intervention Type: DRUG

intravenous injection

CNSR II (2012 to 2013)

For this group following patients will be analysed:

The overall AIS patients aged 18 to 80 years who arrived at hospital within 7 days of symptom onset (Patient group A)

Thereof: IVT eligible patients:

AIS patients who arrived at hospital within 2 hours (patient group B) and 3.5 hours (patient group B') of symptom onset and with no documented absolute contraindications to IVT treatment

Thereof: IV rtPA treated patients:

IVT eligible patients who arrived at hospital within 2 hours of symptom onset and received IV rtPA within 3 hours of symptom onset (patient group C) and those who arrived at hospital within 3.5 hours of symptom onset and received IV rtPA within 4.5 hours of symptom onset (patient group C')

IV rtPA (intravenous recombinant plasminogen activator)

Intervention Type: DRUG

intravenous injection

CNSR III (2015 to 2017)

For this group following patients will be analysed:

The overall AIS patients aged 18 to 80 years who arrived at hospital within 7 days of symptom onset (Patient group A)

Thereof: IVT eligible patients:

AIS patients who arrived at hospital within 2 hours (patient group B) and 3.5 hours (patient group B') of symptom onset and with no documented absolute contraindications to IVT treatment

Thereof: IV rtPA treated patients:

IVT eligible patients who arrived at hospital within 2 hours of symptom onset and received IV rtPA within 3 hours of symptom onset (patient group C) and those who arrived at hospital within 3.5 hours of symptom onset and received IV rtPA within 4.5 hours of symptom onset (patient group C')

IV rtPA (intravenous recombinant plasminogen activator)

Intervention Type: DRUG

intravenous injection

Interventions

IV rtPA (intravenous recombinant plasminogen activator)

intravenous injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient group A: All AIS patients

• Aged 18 80 years
• Diagnosed with AIS on admission
• Patient groups B and B': IVT eligible patients

Exclusion Criteria

• Arrived at hospital within 2 h (patient group B) or 3.5 h (patient group B') of symptom onset
• Patient groups C and C': IV rtPA treated patients

• Treated with IV rtPA within 3 h (patient group C) or 4.5 h (patient group C') of symptom onset

• Patient group A: All AIS patients

• Missing baseline data including age and gender
• Diagnosed with intracranial hemorrhage (ICH), Transient Ischemic Attack (TIA), subarachnoid hemorrhage (SAH), or unspecific stroke
• Arrived at hospital after 7 days of symptom onset
• Patient groups B and B': IVT eligible patients

• Missing key data including:

i. symptom onset time (or last known well time) ii. hospital arrival time iii. whether received IVT treatment or not iv. the time of IVT treatment

• Documented IVT absolute contraindications, according to the case report form (CRF) for each wave of CNSR
• Patient groups C and C': IV rtPA treated patients

• Not received IVT
• Received IVT other than rtPA
• Treated with IV rtPA after 3 h (patient group C) or 4.5 h (patient group C') of symptom onset
• Received additional treatments with intra arterial reperfusion or experimental therapies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tiantan Hospital

Beijing, , China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.mystudywindow.com/

Related Info

Other Identifiers

0135-0343

Identifier Type: -

Identifier Source: org_study_id