StrokeNCT04290494

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;

An observational study of Stroke, run by Boehringer Ingelheim at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Stroke
What is being tested?: IV rtPA (intravenous recombinant plasminogen activator)
Type of treatment: Injection or infusion
How many people: 42,188 participants
Where: 1 siteChina
Study dates: 21 Sep 2020to 30 Sep 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

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').

Who may be able to join

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

Show all 9Show fewer

Patient groups C and C': IV rtPA treated patients
Met the in- and exclusion criteria of "IVT eligible patients"
Treated with IV rtPA within 3 h (patient group C) or 4.5 h (patient group C') of symptom onset

Who cannot join

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:

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Tiantan Hospital
Beijing, 100070

Other trials in China

About this study

Official title: 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

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
Being tested: IV rtPA (intravenous recombinant plasminogen activator)
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IV rtPA (intravenous recombinant plasminogen activator)Drug
intravenous injection

Study groups in NCT04290494
Study group	Role	What they receive
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') Receives: 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') Receives: 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') Receives: Drug: IV rtPA (intravenous recombinant plasminogen activator)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: From symptom onset until arrival at the hospital, up to 120 minutes.
Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 3 Hours IV-rtPA Treated Patients
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.
Measured: From symptom onset until administration of Intravenous Recombinant Plasminogen Activator, up to 180 minutes.
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
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.
Measured: From arrival at the hospital until the administration of Intravenous Recombinant Plasminogen Activator, up to 247 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 4.5 Hours IV-rtPA Treated Patients
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.
Measured: From 2007 to 2017, up to 10 years before this study started.
Time Between Symptom Onset and Arrival at Hospital Among 4.5 Hours Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treated Patients
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
Measured: From symptom onset until arrival at the hospital, up to 210 minutes.
Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 4.5 Hours IV-rtPA Treated Patients
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
Measured: From symptom onset until the administration of Intravenous Recombinant Plasminogen Activator, up to 270 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Sep 202030 Sep 2020

First posted2 Mar 2020
Study start21 Sep 2020
Primary completion30 Sep 2020
Study completion30 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 42,188 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04290494
Sponsor's protocol ID: 0135-0343
Status last verified: Nov 2021
First submitted: 27 Feb 2020
Last updated: 5 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://trials.boehringer-ingelheim.com/trial\_results/clinical\_submission\_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringer-ingelheim.com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Publications

Li L, Pan Y, Yan H, Wu Y, Sun F, Shi X, Zhou Y, Wang Y. Predictive role of baseline serum creatinine-to-cystatin C ratio for renal dysfunction incidence in patients with acute ischemic stroke. BMC Nephrol. 2026 Feb 11;27(1):172. doi: 10.1186/s12882-026-04779-3.
PubMed 41673614

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04290494
Acronym / sponsor ID: 0135-0343
Conditions: Stroke
Study type: Observational
Recruitment status: Completed
Enrolment: 42,188 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 21 Sep 2020 (actual)
Primary completion: 30 Sep 2020 (actual)
Study completion: 30 Sep 2020 (actual)
First posted: 2 Mar 2020 (actual)
Results: Posted 5 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
CNSR I (2007 to 2008)	–	Drug: IV rtPA (intravenous recombinant plasminogen activator)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')
CNSR II (2012 to 2013)	–	Drug: IV rtPA (intravenous recombinant plasminogen activator)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')
CNSR III (2015 to 2017)	–	Drug: IV rtPA (intravenous recombinant plasminogen activator)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')

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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').

Key inclusion criteria (9 listed)

Patient group A: All AIS patients
Patient groups B and B': IVT eligible patients
Patient groups C and C': IV rtPA treated patients

Key exclusion criteria (13 listed)

Patient group A: All AIS patients
Patient groups B and B': IVT eligible patients
Patient groups C and C': IV rtPA treated patients

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IV rtPA (intravenous recombinant plasminogen activator)intravenous injection	Drug	CNSR I (2007 to 2008), CNSR II (2012 to 2013), CNSR III (2015 to 2017)

Primary outcome

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
Time frame: 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
Time frame: 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.

10 secondary outcomes

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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From symptom onset until arrival at the hospital, up to 120 minutes.
Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 3 Hours IV-rtPA Treated Patients
Time frame: From symptom onset until administration of Intravenous Recombinant Plasminogen Activator, up to 180 minutes.
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
Time frame: From arrival at the hospital until the administration of Intravenous Recombinant Plasminogen Activator, up to 247 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 4.5 Hours IV-rtPA Treated Patients
Time frame: From 2007 to 2017, up to 10 years before this study started.
Time Between Symptom Onset and Arrival at Hospital Among 4.5 Hours Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treated Patients
Time frame: From symptom onset until arrival at the hospital, up to 210 minutes.
Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 4.5 Hours IV-rtPA Treated Patients
Time frame: From symptom onset until the administration of Intravenous Recombinant Plasminogen Activator, up to 270 minutes.

Results and safety

Results posted to the registry on 5 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
China National Stroke Registry (CNSR) I (2007 to 2008)	10,968	10,968
China National Stroke Registry (CNSR) II (2012 to 2013)	17,823	17,823
China National Stroke Registry (CNSR) III (2015 to 2017)	13,397	13,397

Primary outcome: 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

Time frame: From 2007 to 2017, up to 10 years before this study started.. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	China National Stroke Registry (CNSR) I (2007 to 2008) n = 866	China National Stroke Registry (CNSR) II (2012 to 2013) n = 2214	China National Stroke Registry (CNSR) III (2015 to 2017) n = 1679
Value	11.66 (9.53 to 13.80)	10.66 (9.37 to 11.94)	28.77 (26.60 to 30.93)

Population analysed: All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) phase I to phase III with treatment from 2007 to 2017. Only those patients eligible for intravenous thrombolytics (IVT) who arrived at the hospital within 2 hours since symptom onset were included in the analysis.

Primary outcome: 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

Time frame: From 2007 to 2017, up to 10 years before this study started.. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	China National Stroke Registry (CNSR) I (2007 to 2008) n = 1271	China National Stroke Registry (CNSR) II (2012 to 2013) n = 3684	China National Stroke Registry (CNSR) III (2015 to 2017) n = 2787
Value	13.53 (11.65 to 15.41)	7.11 (6.28 to 7.94)	33.44 (31.69 to 35.19)

Population analysed: All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) phase I to phase III with treatment from 2007 to 2017. Only those patients eligible for intravenous thrombolytics (IVT) who arrived at the hospital within 3.5 hours since symptom onset were included in the analysis.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event information was not collected for this study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
China National Stroke Registry (CNSR) I (2007 to 2008)	0 of 0	0 of 0
China National Stroke Registry (CNSR) II (2012 to 2013)	0 of 0	0 of 0
China National Stroke Registry (CNSR) III (2015 to 2017)	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41673614Li L, Pan Y, Yan H, Wu Y, Sun F, Shi X, Zhou Y, Wang Y. Predictive role of baseline serum creatinine-to-cystatin C ratio for renal dysfunction incidence in patients with acute ischemic stroke. BMC Nephrol. 2026 Feb 11;27(1):172. doi: 10.1186/s12882-026-04779-3.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://trials.boehringer-ingelheim.com/trial_results/clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringer-ingelheim.com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Boehringer Ingelheim at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: From 2007 to 2017, up to 10 years before this study started.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04290494, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.