NCT05395351 is a clinical trial of rt-PA in Stroke, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT05395351?

NCT05395351 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT05395351?

Interventions in NCT05395351: rt-PA.

Is NCT05395351 still recruiting?

NCT05395351 is currently completed. Last updated 20 December 2024.

Are results published for NCT05395351?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-12-20 · How we verify

NCT05395351

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Results posted Last updated 20 December 2024

What this trial tests

trial testing rt-PA in Stroke in 113,035 participants. Completed in 28 March 2023.

Timeline

30 November 2022

Primary endpoint
28 March 2023

28 March 2023

Quick facts

Lead sponsor	Boehringer Ingelheim
Status	Completed
Study type	OBSERVATIONAL
Enrollment	113,035
Start date	30 November 2022
Primary completion	28 March 2023
Estimated completion	28 March 2023
Sites	1 location across China

Drugs / interventions tested

rt-PA — full drug profile →

Conditions studied

Stroke — all drugs for Stroke →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients Primary · 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).

Group	Value	95% CI
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)	2.6	2.1 – 3.2
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)	0.8	0.7 – 0.9

Percentage of Patients With Hemorrhagic Stroke During Hospitalization Secondary · Up to 100 days.

Percentage of patients with hemorrhagic stroke during hospitalization.

Group	Value	95% CI
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)	6.7	5.8 – 7.5
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)	3.1	2.9 – 3.3

Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment Secondary · Up to 24 hours.

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.

Group	Value	95% CI
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)	2.8	± 5.0
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)	2.5	± 4.3

Modified Rankin Score (mRS) at Discharge Secondary · Up to 100 days.

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.

Group	Value	95% CI
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)	383
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)	5447
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)	612
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)	6427
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)	281
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)	2131
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)	216
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)	1393

Number of Patients With Stroke Recurrence During Hospitalization Secondary · Up to 100 days.

Number of patients with stroke recurrence during hospitalization.

Group	Value	95% CI
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)	369
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)	2039

Length of Hospitalization Secondary · Up to 100 days.

Length of hospitalization.

Group	Value	95% CI
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)	12.7	± 9.6
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)	11.5	± 7.6

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 Secondary · Up to 4.5 hours.

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.

Group	Value	95% CI
Acute Ischemic Stroke (AIS) Patients Aged >80 Years	21.0	20.4 – 21.6
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years	28.9	28.6 – 29.2

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) Secondary · 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).

Group	Value	95% CI
Acute Ischemic Stroke (AIS) Patients Aged >80 Years	23.9	23.2 – 24.6
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years	32.2	31.8 – 32.5

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

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.
Jiang Y, Wang C, Gu H, Zhou Q, et al · · 2025 · PMID 39477171 · DOI 10.1016/j.jstrokecerebrovasdis.2024.108102

Verify or expand the search:

Other trials of rt-PA

Trials testing the same drug.

NCT07519889 — Observational Study to Assess the Safety of rhTNK-tPA (Mingfule®) vs. Rt-PA (Actilyse®) in Treating Acute Ischemic Strok · not yet recruiting
NCT07111559 — Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial · Phase 4 · recruiting
NCT05700591 — rhPro-UK in Acute Ischaemic Stroke Within 4.5 Hours of Stroke Onset Trial 2(PROST-2) · Phase 3 · completed
NCT05401149 — Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients · completed
NCT05395338 — 1-year Clinical Outcomes in Recombinant Tissue Plasminogen Activator (Rt-PA) Treated Chinese Acute Ischaemic Stroke (AIS · completed

Other recruiting trials for Stroke

Currently open trials in the same condition.

NCT06615973 — Screening for Social Determinants of Health (SDOH) and Cognitive Function in Individuals With History of Stroke · recruiting
NCT07494890 — Measurement Properties of Mechanical Cost of Walking for Individuals With Walking Impairment · NA · recruiting
NCT07356011 — Exoskeleton for Balance · NA · recruiting
NCT07523503 — Unilateral Versus Bilateral Task-specific Training on Motor Impairment, Upper Extremity Function, and Hand Dexterity in · NA · recruiting
NCT06704074 — Virtual Reality Task Oriented Training on Upper Limb Function in Stroke Patients · NA · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05395351 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 20 December 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05395351.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing