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;

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04290494

Enrollment

42188

Registered

2020-03-02

Start date

2020-09-21

Completion date

2020-09-30

Last updated

2021-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

DRUGIV rtPA (intravenous recombinant plasminogen activator)

intravenous injection

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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 * Met the in- and

Exclusion criteria

of all AIS patients * 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 * Met the in- and

Design outcomes

Primary

Measure	Time frame	Description
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	From 2007 to 2017, up to 10 years before this study started.	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.
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	From 2007 to 2017, up to 10 years before this study started.	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.

Secondary

Measure	Time frame	Description
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.	The door to needle (DTN) time (time between arrival at hospital and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment) among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset was reported.
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.	The 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 patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset was reported.
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.	Time between symptom onset and arrival at hospital among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset was reported.
Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 3 Hours IV-rtPA Treated Patients	From symptom onset until administration of Intravenous Recombinant Plasminogen Activator, up to 180 minutes.	Time between symptom onset and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset was reported.
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 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 was reported.
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 4.5 Hours IV-rtPA Treated Patients	From 2007 to 2017, up to 10 years before this study started.	The 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 patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset was reported.
Time Between Symptom Onset and Arrival at Hospital Among 4.5 Hours Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treated Patients	From symptom onset until arrival at the hospital, up to 210 minutes.	Time between symptom onset and arrival at hospital among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset was reported
Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 4.5 Hours IV-rtPA Treated Patients	From symptom onset until the administration of Intravenous Recombinant Plasminogen Activator, up to 270 minutes.	Time between symptom onset and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset was reported
The Door to Needle (DTN) Time (Time Between Arrival at Hospital and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment) Among 4.5 Hours IV-rtPA Treated Patients	From arrival at the hospital until the administration of Intravenous Recombinant Plasminogen Activator, up to 247 minutes.	The door to needle (DTN) time (time between arrival at hospital and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment) among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset was reported.
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.	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 was reported.

Countries

China

Participant flow

Recruitment details

This non-interventional study was based on Chinese acute ischemic stroke patients who had treatment from 2007 to 2017 from the existing data of the China National Stroke Registry (CNSR) I, II, and III to investigate the temporal trends of thrombolysis treatment in Chinese acute ischemic stroke patients.

Pre-assignment details

All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I, II, and III with treatment from 2007 to 2017 were included.

Participants by arm

Arm	Count
China National Stroke Registry (CNSR) I (2007 to 2008) All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.	10,968
China National Stroke Registry (CNSR) II (2012 to 2013) All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.	17,823
China National Stroke Registry (CNSR) III (2015 to 2017) All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.	13,397
Total	42,188

Baseline characteristics

Characteristic	China National Stroke Registry (CNSR) I (2007 to 2008)	China National Stroke Registry (CNSR) II (2012 to 2013)	China National Stroke Registry (CNSR) III (2015 to 2017)	Total
Age, Continuous	63.5 Years STANDARD_DEVIATION 11.1	62.9 Years STANDARD_DEVIATION 10.8	61.2 Years STANDARD_DEVIATION 10.4	62.5 Years STANDARD_DEVIATION 10.8
Race and Ethnicity Not Collected	—	—	—	0 Participants
Sex: Female, Male Female	4053 Participants	6350 Participants	4114 Participants	14517 Participants
Sex: Female, Male Male	6915 Participants	11473 Participants	9283 Participants	27671 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0	0 / 0

Outcome results

Primary

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.