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

NCT05395351 | Completed Results

• 1 other identifier: 0135-0348
• Study Type: observational
• Target: 113,035
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 100 days.

Secondary Outcomes (7)

• Percentage of Patients With Hemorrhagic Stroke During Hospitalization

  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

  Up to 24 hours.

• Modified Rankin Score (mRS) at Discharge

  Up to 100 days.

• Number of Patients With Stroke Recurrence During Hospitalization

  Up to 100 days.

• Length of Hospitalization

  Up to 100 days.

Study Arms (4)

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.

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.

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.

Interventions

rt-PA DRUG

Intravenous recombinant tissue plasminogen activator (IV rt-PA)

Also known as: Alteplase

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Boehringer Ingelheim (China) Investment Co., ltd.

Shanghai, 200040, China

Location

Related Publications (1)

• 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.

  PMID: 39477171 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Stroke

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Limitations and Caveats

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.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 27, 2022
• Study Start: November 30, 2022
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2023
• Last Updated: December 20, 2024
• Results First Posted: December 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)