StrokeNCT05401149

Alteplase Treatment in Elderly 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 this study is to find out if Chinese Acute Ischaemic Stroke (AIS) patients older than 80 years benefit from intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) treatment within 4.5 hours of symptom onset in a real-world clinical setting. Read more about this study

Who is it for?: Ages 80 years and older
Conditions the study is for: Stroke
What is being tested?: rt-PA
Type of treatment: Injection or infusion
How many people: 3,058 participants
Where: 1 siteChina
Study dates: 18 Jul 2022to 14 Dec 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 80 years and older
All sexes
No healthy volunteers
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 Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020
> 80 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: Effectiveness and Safety of IV Rt-PA Treatment in Chinese AIS Patients Aged Above 80 Years: a Real-world Study

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 NCT05401149
Study group	Role	What they receive
IV rt-PA cohort		Acute Ischaemic Stroke (AIS) patients aged > 80 years who received intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) (Alteplase) within 4.5 hours of symptom onset Receives: Drug: rt-PA
Non-reperfusion cohort		Acute Ischaemic Stroke (AIS) patients aged > 80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatments

What is being measured

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

Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year
Percentage of patients with favourable outcome (modified Rankin Scale (mRS) 0-1) 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.
2. - Slight disability.
3. - Moderate disability.
4. - Moderately severe disability.
5. - Severe disability.
6. - Dead.
Reported percentages of subjects were calculated from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.
Measured: Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study).

Secondary outcomes (5)

Percentage of Patients With Any Intracranial Haemorrhage (ICH) During Hospitalisation
Percentage of patients with any intracranial haemorrhage (ICH) during hospitalisation.
Reported percentages of subjects were calculated from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission.
Measured: Up to 3 months
All-cause Mortality During Hospitalisation
All-cause mortality during hospitalisation.
Reported percentages of subjects were calculated from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission.
Measured: Up to 3 months
Percentage of Patients With Independence (Modified Rankin Scale (mRS) 0-2) at 1 Year
Percentage of patients with independence (modified Rankin Scale (mRS) 0-2) 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.
2. - Slight disability.
3. - Moderate disability.
4. - Moderately severe disability.
5. - Severe disability.
6. - Dead.
Reported percentages of subjects were calculated from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.
Measured: Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study).
Distribution of Modified Rankin Scale (mRS) Score at 1 Year
Distribution of modified Rankin Scale (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.
The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. 0 - No symptoms.
1. - No significant disability.
2. - Slight disability.
3. - Moderate disability.
4. - Moderately severe disability.
5. - Severe disability.
6. - Dead.
Reported percentages of subjects were calculated from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.
Measured: Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study).
All-cause Mortality at 1 Year
All-cause mortality at 1 year.
Measured: Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study).

Timeline

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

18 Jul 202214 Dec 2022

First posted2 Jun 2022
Study start18 Jul 2022
Primary completion14 Dec 2022
Study completion14 Dec 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: 3,058 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05401149
Sponsor's protocol ID: 0135-0349
Status last verified: Oct 2024
First submitted: 25 May 2022
Last updated: 17 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

Yang J, Huang YH, Zhong W, Gong X, Chen Y, Chen Z, Jin H, Yan S, Huang L, Yuan CZ, Lou M. Effectiveness of intravenous recombinant plasminogen activator treatment in Chinese patients with acute ischaemic stroke aged over 80 years: a retrospective cohort study. Stroke Vasc Neurol. 2026 Mar 4;11(1):36-44. doi: 10.1136/svn-2024-004004.
PubMed 40312065

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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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness and Safety of IV Rt-PA Treatment in Chinese AIS Patients Aged Above 80 Years: a Real-world Study
ClinicalTrials.gov ID: NCT05401149
Acronym / sponsor ID: 0135-0349
Conditions: Stroke
Study type: Observational
Recruitment status: Completed
Enrolment: 3,058 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 18 Jul 2022 (actual)
Primary completion: 14 Dec 2022 (actual)
Study completion: 14 Dec 2022 (actual)
First posted: 2 Jun 2022 (actual)
Results: Posted 17 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-PAAcute Ischaemic Stroke (AIS) patients aged > 80 years who received intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) (Alteplase) within 4.5 hours of symptom onset
Non-reperfusion cohort	–	–Acute Ischaemic Stroke (AIS) patients aged > 80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatments

Who may qualify

Ages: 80 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: 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 Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020
> 80 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

Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year
Time frame: Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study).
Percentage of patients with favourable outcome (modified Rankin Scale (mRS) 0-1) 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. 2. - Slight disability. 3. - Moderate disability. 4. - Moderately severe disability. 5. - Severe disability. 6. - Dead. Reported percentages of subjects were calculated from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.

5 secondary outcomes

Percentage of Patients With Any Intracranial Haemorrhage (ICH) During Hospitalisation
Time frame: Up to 3 months
All-cause Mortality During Hospitalisation
Time frame: Up to 3 months
Percentage of Patients With Independence (Modified Rankin Scale (mRS) 0-2) at 1 Year
Time frame: Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study).
Distribution of Modified Rankin Scale (mRS) Score at 1 Year
Time frame: Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study).
All-cause Mortality at 1 Year
Time frame: Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study).

Results and safety

Results posted to the registry on 17 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	780	780
Non-reperfusion Cohort	780	780

Primary outcome: Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year

Time frame: Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study).. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	IV Rt-PA Cohort n = 780	Non-reperfusion Cohort n = 780
Value	27.7 (24.6 to 30.8)	23.8 (20.9 to 26.8)

IV Rt-PA Cohort vs Non-reperfusion Cohort: Odds Ratio (OR): 1.87 (95% CI 1.35 to 2.59), p <0.001, Regression, Logistic

Population analysed: Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1), clinical outcomes and baseline characteristics were compared between the matched cohorts. Patients \>80 years old and registered in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020.

5 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	308 of 780
Non-reperfusion Cohort	0 of 0	0 of 0	303 of 780

Limitations and caveats (from the sponsor): According to Boehringer Ingelheim's internal policy, no document date is required in the title page of the Statistical and Epidemiological Analysis Plan

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40312065Yang J, Huang YH, Zhong W, Gong X, Chen Y, Chen Z, Jin H, Yan S, Huang L, Yuan CZ, Lou M. Effectiveness of intravenous recombinant plasminogen activator treatment in Chinese patients with acute ischaemic stroke aged over 80 years: a retrospective cohort study. Stroke Vasc Neurol. 2026 Mar 4;11(1):36-44. doi: 10.1136/svn-2024-004004.
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

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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 17 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 17 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?

Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year (time frame: Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study).). 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 NCT05401149, 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 17 Oct 2024.