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;

NCT04290494 | Completed Results

• 1 other identifier: 0135-0343
• Study Type: observational
• Target: 42,188
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Percentage of Patients Who Received Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Within 3 Hours of Symptom Onset Among 2 Hours Intravenous Thrombolytics (IVT) Eligible Patients

  The percentage of patients who received Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment within 3 hours of symptom onset among patients eligible for intravenous thrombolytics (IVT) who arrived at the hospital within 2 hours since symptom onset was reported.

  From 2007 to 2017, up to 10 years before this study started.

• Percentage of Patients Who Received Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Within 4.5 Hours of Symptom Onset Among 3.5 Hours Intravenous Thrombolytics (IVT) Eligible Patients

  The percentage of patients who received Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment within 4.5 hours of symptom onset among patients eligible for intravenous thrombolytics (IVT) who arrived at the hospital within 3.5 hours since symptom onset was reported.

  From 2007 to 2017, up to 10 years before this study started.

Secondary Outcomes (10)

• Percentage of Patients Who Arrived at Hospital Within 2 Hours of Symptom Onset and Who Received Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Within 3 Hours of Symptom Onset Among All Eligible Patients

  From 2007 to 2017, up to 10 years before this study started.

• Percentage of Patients Who Arrived at Hospital Within 3.5 Hours of Symptom Onset and Who Received Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Within 4.5 Hours of Symptom Onset Among All Eligible Patients

  From 2007 to 2017, up to 10 years before this study started.

• The Door to Needle (DTN) Time (Time Between Arrival at Hospital and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment) Among 3 Hours IV-rtPA Treated Patients

  From arrival at the hospital until the administration of Intravenous Recombinant Plasminogen Activator, up to 170 minutes.

• Percentage of Patients With Door to Needle (DTN) Time (Time Between Arrival at Hospital and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment) ≤ 60 Minutes Among 3 Hours IV-rtPA Treated Patients

  From 2007 to 2017, up to 10 years before this study started.

• Time Between Symptom Onset and Arrival at Hospital Among 3 Hours Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treated Patients

  From symptom onset until arrival at the hospital, up to 120 minutes.

Study Arms (3)

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')

Drug: IV rtPA (intravenous recombinant plasminogen activator)

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')

Drug: IV rtPA (intravenous recombinant plasminogen activator)

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')

Drug: IV rtPA (intravenous recombinant plasminogen activator)

Interventions

IV rtPA (intravenous recombinant plasminogen activator) DRUG

intravenous injection

CNSR I (2007 to 2008); CNSR II (2012 to 2013); CNSR III (2015 to 2017)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All eligible patients from the CNSR I to III will be included. Patient groups include the overall AIS patients (patient group A), IVT eligible patients (patient groups B and B'), and IV rtPA treated patients (patient groups C and C').

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, 100070, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 2, 2020
• Study Start: September 21, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: November 5, 2021
• Results First Posted: November 5, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.

Locations

CN (1)