StrokeNCT05395351

Alteplase in Elderly Acute Ischemic Stroke (AIS) Patients During Hospitalization

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 in-hospital clinical outcomes among Chinese Acute Ischaemic Stroke (AIS) patients, who were treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset in different age groups (18 to 80 years and above 80 years). 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: 113,035 participants
Where: 1 siteChina
Study dates: 30 Nov 2022to 28 Mar 2023
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: Acute ischemic stroke (AIS) patients who were treated with Intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) or did not receive thrombolysis treatment within 4.5 hours of symptom onset, aged ≥18 years old.

Who may be able to join

Patient registered in the Chinese Stroke Centre Alliance (CSCA) platform from Aug 2015 to Jul 2019
≥18 years old
Diagnosed as Acute Ischemic Stroke (AIS) at admission
Arrived or admitted into hospital within 4.5 hours of symptom onset
For patients in the iv rt-PA groups only: received IV rt-PA within 4.5 hours of symptom onset

Who cannot join

Documented Intravenous Thrombolysis (IVT) absolute contraindication
Key data missing (age, gender, baseline National Institutes of Health Stroke Scale [NIHSS], time of symptom onset, IVT treated or not, time of IV alteplase treatment)
Received thrombolysis agents other than IV 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: Characteristics and In-hospital Outcomes of Chinese Elderly (>80 Years) Patients With Acute Ischemic Stroke Receiving Intravenous Recombinant Tissue Plasminogen Activator Treatment Within 4.5 Hours of Symptom Onset

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
Also called Alteplase
Intravenous recombinant tissue plasminogen activator (IV rt-PA)

Study groups in NCT05395351
Study group	Role	What they receive
Acute ischemic stroke (AIS) patients aged >80 years who received IV rt-PA (Alteplase)		Group 1: Acute ischemic stroke (AIS) patients aged >80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset. Receives: Drug: rt-PA
Acute ischemic stroke (AIS) patients aged 18 to 80 years who received IV rt-PA (Alteplase)		Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset. Receives: Drug: rt-PA
Acute ischemic stroke (AIS) patients aged >80 years without thrombolysis treatment		Group 3: Acute ischemic 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 thrombolysis treatment.
Acute ischemic stroke (AIS) patients aged 18 to 80 years without thrombolysis treatment		Group 4: Acute ischemic stroke (AIS) patients aged 18 to 80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment.

What is being measured

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

All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients
All-cause mortality during hospitalization of acute ischemic stroke (AIS) patients who received intravenous recombinant tissue plasminogen activator (IV rt-PA).
Measured: Up to 100 days.

Secondary outcomes (7)

Percentage of Patients With Hemorrhagic Stroke During Hospitalization
Percentage of patients with hemorrhagic stroke during hospitalization.
Measured: Up to 100 days.
Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment
The National Institutes of Health Stroke Scale (NIHSS) is a scale of stroke severity, it ranges from 0 to 42 where a score of 0 indicates no stroke symptoms and higher scores indicate incremental levels of neurologcial impairment.
Measured: Up to 24 hours.
Modified Rankin Score (mRS) at Discharge
The Modified Rankin Score (mRS) ranges from 0 to 6, where 0 indicates no symptoms, 1 no significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability and 6 death.
Measured: Up to 100 days.
Number of Patients With Stroke Recurrence During Hospitalization
Number of patients with stroke recurrence during hospitalization.
Measured: Up to 100 days.
Length of Hospitalization
Length of hospitalization.
Measured: Up to 100 days.
Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Among Acute Ischemic Stroke (AIS) Patients Arrived or Were Admitted to the Hospital Within 4.5 Hours of Symptom Onset
Percentage of intravenous recombinant tissue plasminogen activator (IV rt-PA) treatment among acute ischemic stroke (AIS) patients arrived or were admitted to the hospital within 4.5 hours of symptom onset.
Measured: Up to 4.5 hours.
Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Within 4.5 Hours of Symptom Onset Among Eligible AIS Patients (3.5-hour Arrival or Admission)
Percentage of intravenous recombinant tissue plasminogen activator (IV rt-PA) treatment within 4.5 hours of symptom onset among eligible AIS patients (3.5-hour arrival or admission).
Measured: Up to 4.5 hours.

Timeline

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

30 Nov 202228 Mar 2023

First posted27 May 2022
Study start30 Nov 2022
Primary completion28 Mar 2023
Study completion28 Mar 2023

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: 113,035 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05395351
Sponsor's protocol ID: 0135-0348
Status last verified: Nov 2024
First submitted: 25 May 2022
Last updated: 20 Dec 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

Jiang Y, Wang C, Gu H, Zhou Q, Jiang Y, Li Z, Wang Y. In-hospital outcomes of intravenous recombinant tissue plasminogen activator treatment for acute ischemic stroke in patients aged >80 years: Findings from the Chinese Stroke Center Alliance. J Stroke Cerebrovasc Dis. 2025 Jan;34(1):108102. doi: 10.1016/j.jstrokecerebrovasdis.2024.108102. Epub 2024 Oct 28.
PubMed 39477171

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 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characteristics and In-hospital Outcomes of Chinese Elderly (>80 Years) Patients With Acute Ischemic Stroke Receiving Intravenous Recombinant Tissue Plasminogen Activator Treatment Within 4.5 Hours of Symptom Onset
ClinicalTrials.gov ID: NCT05395351
Acronym / sponsor ID: 0135-0348
Conditions: Stroke
Study type: Observational
Recruitment status: Completed
Enrolment: 113,035 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 30 Nov 2022 (actual)
Primary completion: 28 Mar 2023 (actual)
Study completion: 28 Mar 2023 (actual)
First posted: 27 May 2022 (actual)
Results: Posted 20 Dec 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: 4

Arm	Type	Receives
Acute ischemic stroke (AIS) patients aged >80 years who received IV rt-PA (Alteplase)	–	Drug: rt-PAGroup 1: Acute ischemic stroke (AIS) patients aged >80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
Acute ischemic stroke (AIS) patients aged 18 to 80 years who received IV rt-PA (Alteplase)	–	Drug: rt-PAGroup 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
Acute ischemic stroke (AIS) patients aged >80 years without thrombolysis treatment	–	–Group 3: Acute ischemic 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 thrombolysis treatment.
Acute ischemic stroke (AIS) patients aged 18 to 80 years without thrombolysis treatment	–	–Group 4: Acute ischemic stroke (AIS) patients aged 18 to 80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Acute ischemic stroke (AIS) patients who were treated with Intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) or did not receive thrombolysis treatment within 4.5 hours of symptom onset, aged ≥18 years old.

Key inclusion criteria (5 listed)

Patient registered in the Chinese Stroke Centre Alliance (CSCA) platform from Aug 2015 to Jul 2019
≥18 years old
Diagnosed as Acute Ischemic Stroke (AIS) at admission
Arrived or admitted into hospital within 4.5 hours of symptom onset
For patients in the iv rt-PA groups only: received IV rt-PA within 4.5 hours of symptom onset

Key exclusion criteria (5 listed)

Documented Intravenous Thrombolysis (IVT) absolute contraindication
Key data missing (age, gender, baseline National Institutes of Health Stroke Scale [NIHSS], time of symptom onset, IVT treated or not, time of IV alteplase treatment)
Received thrombolysis agents other than IV 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-PAAlso: AlteplaseIntravenous recombinant tissue plasminogen activator (IV rt-PA)	Drug	Acute ischemic stroke (AIS) patients aged 18 to 80 years who received IV rt-PA (Alteplase), Acute ischemic stroke (AIS) patients aged >80 years who received IV rt-PA (Alteplase)

Primary outcome

All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients
Time frame: Up to 100 days.
All-cause mortality during hospitalization of acute ischemic stroke (AIS) patients who received intravenous recombinant tissue plasminogen activator (IV rt-PA).

7 secondary outcomes

Percentage of Patients With Hemorrhagic Stroke During Hospitalization
Time frame: Up to 100 days.
Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment
Time frame: Up to 24 hours.
Modified Rankin Score (mRS) at Discharge
Time frame: Up to 100 days.
Number of Patients With Stroke Recurrence During Hospitalization
Time frame: Up to 100 days.
Length of Hospitalization
Time frame: Up to 100 days.
Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Among Acute Ischemic Stroke (AIS) Patients Arrived or Were Admitted to the Hospital Within 4.5 Hours of Symptom Onset
Time frame: Up to 4.5 hours.
Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Within 4.5 Hours of Symptom Onset Among Eligible AIS Patients (3.5-hour Arrival or Admission)
Time frame: Up to 4.5 hours.

Results and safety

Results posted to the registry on 20 Dec 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
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)	3,332	3,332
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)	28,086	28,086
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment	12,533	12,533
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment	69,084	69,084

Primary outcome: All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients

Time frame: Up to 100 days.. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) n = 3332	Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) n = 28086
Value	2.6 (2.1 to 3.2)	0.8 (0.7 to 0.9)

Population analysed: Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase). Endpoint was planned to only include Group 1 and 2.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event information was not applicable for this study. All-cause mortality was only collected and reported for group 1 and group 2 for up to 100 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)	0 of 0	0 of 0	88 of 3,332
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)	0 of 0	0 of 0	211 of 28,086
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment	0 of 0	0 of 0	0
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Hospital participation in the Chinese Stroke Centre Alliance (CSCA) was voluntary. To avoid selection bias, all patients were included without sampling when dataset was extracted. The larger sample size and broad geological distribution increased representativeness. Data collected by hospitals were not audited by external chart review. Data reliability depends on training for data abstractors and automated checks to identify erroneous, illogical data entries.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39477171Jiang Y, Wang C, Gu H, Zhou Q, Jiang Y, Li Z, Wang Y. In-hospital outcomes of intravenous recombinant tissue plasminogen activator treatment for acute ischemic stroke in patients aged >80 years: Findings from the Chinese Stroke Center Alliance. J Stroke Cerebrovasc Dis. 2025 Jan;34(1):108102. doi: 10.1016/j.jstrokecerebrovasdis.2024.108102. Epub 2024 Oct 28.
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

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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 20 Dec 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 20 Dec 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 During Hospitalization of Acute Ischemic Stroke (AIS) Patients (time frame: Up to 100 days.). 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 NCT05395351, 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 20 Dec 2024.