StrokeNCT05395338

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

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 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke
What is being tested?: rt-PA
Type of treatment: Injection or infusion
How many people: 12,551 participants
Where: 1 siteChina
Study dates: 12 Apr 2022to 30 Nov 2022
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: In this study, AIS patient data from 80 stroke centres in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from January 2017 to March 2020 will be used.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Boehringer Ingelheim (China) Investment Co., ltd.
Shanghai, 200040

Other trials in China

About this study

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

Conditions: Stroke
Being tested: rt-PA
Medical subject headings: Stroke

What participants receive

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

rt-PADrug
Recombinant Tissue Plasminogen Activator

Study groups in NCT05395338
Study group	Role	What they receive
IV rt-PA cohort		Patients who received IV rt-PA within 4.5 hours of symptom onset Receives: Drug: rt-PA
Non-reperfusion cohort		Patients who arrived or were admitted to the hospital within4.5 hours of symptom onset and did not receive any reperfusion treatment

What is being measured

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

All-cause Mortality at 1 Year (Percentage of Patients With 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.
1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
3. - Moderate disability. Requires some help, but able to walk unassisted.
4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
6. - Dead.
Measured: Up to 1 year.

Secondary outcomes (4)

Percentage of Patients With Functional Independence (mRS Score 0 to 2) at 1 Year
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.
1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
3. - Moderate disability. Requires some help, but able to walk unassisted.
4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
6. - Dead.
Measured: Up to 1 year.
Percentage of Patients With Favourable Outcome (mRS Score 0 to 1) at 1 Year
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.
1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
3. - Moderate disability. Requires some help, but able to walk unassisted.
4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
6. - Dead.
Measured: Up to 1 year.
Percentage of Patients With mRS Score 5 to 6 at 1 Year
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.
1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
3. - Moderate disability. Requires some help, but able to walk unassisted.
4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
6. - Dead.
Measured: Up to 1 year.
Distribution of mRS Score at 1 Year
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. Clinicians give the mRS score per the clinical diagnosis/symptom to the patient. There is no calculation for this endpoint or each individual components.
The scale runs from 0-6, from 'perfect health without symptoms' to 'death'.
Measured: Up to 1 year.

Timeline

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

12 Apr 202230 Nov 2022

First posted27 May 2022
Study start12 Apr 2022
Primary completion30 Nov 2022
Study completion30 Nov 2022

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: 12,551 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05395338
Sponsor's protocol ID: 0135-0350
Status last verified: Oct 2024
First submitted: 25 May 2022
Last updated: 16 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Publications

Xue R, Gong X, Huang Y, Zhong W, Jin H, Chen Z, Chen Y, Yan S, Hu H, Yuan C, Lou M. One-Year Outcomes After Intravenous Recombinant Tissue Plasminogen Activator for Ischemic Stroke: A Real-World Study. CNS Neurosci Ther. 2025 Aug;31(8):e70543. doi: 10.1111/cns.70543.
PubMed 40772407

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 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 1-year Clinical Outcomes After Intravenous Rt-PA for Chinese AIS Patients
ClinicalTrials.gov ID: NCT05395338
Acronym / sponsor ID: 0135-0350
Conditions: Stroke
Study type: Observational
Recruitment status: Completed
Enrolment: 12,551 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 12 Apr 2022 (actual)
Primary completion: 30 Nov 2022 (actual)
Study completion: 30 Nov 2022 (actual)
First posted: 27 May 2022 (actual)
Results: Posted 16 Oct 2024

Clinical summary

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

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
IV rt-PA cohort	–	Drug: rt-PAPatients who received IV rt-PA within 4.5 hours of symptom onset
Non-reperfusion cohort	–	–Patients who arrived or were admitted to the hospital within4.5 hours of symptom onset and did not receive any reperfusion treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: In this study, AIS patient data from 80 stroke centres in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from January 2017 to March 2020 will be used.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

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
rt-PARecombinant Tissue Plasminogen Activator	Drug	IV rt-PA cohort

Primary outcome

All-cause Mortality at 1 Year (Percentage of Patients With Modified Rankin Scale (mRS) Score =6)
Time frame: Up to 1 year.
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. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead.

4 secondary outcomes

Percentage of Patients With Functional Independence (mRS Score 0 to 2) at 1 Year
Time frame: Up to 1 year.
Percentage of Patients With Favourable Outcome (mRS Score 0 to 1) at 1 Year
Time frame: Up to 1 year.
Percentage of Patients With mRS Score 5 to 6 at 1 Year
Time frame: Up to 1 year.
Distribution of mRS Score at 1 Year
Time frame: Up to 1 year.

Results and safety

Results posted to the registry on 16 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IV Rt-PA Cohort	8,014	8,014
Non-reperfusion Cohort	4,537	4,537

Primary outcome: All-cause Mortality at 1 Year (Percentage of Patients With Modified Rankin Scale (mRS) Score =6)

Time frame: Up to 1 year.. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	IV Rt-PA Cohort n = 3247	Non-reperfusion Cohort n = 3247
Value	11.1 (10.0 to 12.2)	12.2 (11.1 to 13.3)

IV Rt-PA Cohort vs Non-reperfusion Cohort: Hazard Ratio (HR): 0.90 (95% CI 0.78 to 1.05), p = 0.183, Regression, Cox

Population analysed: Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients \>= 18 years old and registered in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-Cause-mortality: From the patient registration in the ZSQCC platform (between January 2017 and March 2020) to 1-year follow-up, up to 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IV Rt-PA Cohort	0 of 0	0 of 0	360 of 3,247
Non-reperfusion Cohort	0 of 0	0 of 0	396 of 3,247

Limitations and caveats (from the sponsor): This was a non-interventional study (NIS) based on existing data, although Propensity Score Matching (PSM) was used, we cannot rule out the influence of other unmeasured confounding factors.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40772407Xue R, Gong X, Huang Y, Zhong W, Jin H, Chen Z, Chen Y, Yan S, Hu H, Yuan C, Lou M. One-Year Outcomes After Intravenous Recombinant Tissue Plasminogen Activator for Ischemic Stroke: A Real-World Study. CNS Neurosci Ther. 2025 Aug;31(8):e70543. doi: 10.1111/cns.70543.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Related trials for Stroke

Not yet recruiting
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RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Recruiting
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Not yet recruiting
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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 5 inclusion and 5 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 16 Oct 2024. 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 16 Oct 2024). 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?

All-cause Mortality at 1 Year (Percentage of Patients With Modified Rankin Scale (mRS) Score =6) (time frame: Up to 1 year.). 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 NCT05395338, 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 16 Oct 2024.