Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients

NCT05401149 | Completed Results

• 1 other identifier: 0135-0349
• Study Type: observational
• Target: 3,058
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Up to 3 months

• All-cause Mortality During Hospitalisation

  Up to 3 months

• Percentage of Patients With Independence (Modified Rankin Scale (mRS) 0-2) at 1 Year

  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

  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

  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).

Study Arms (2)

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

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

Interventions

rt-PA DRUG

Recombinant Tissue Plasminogen Activator

IV rt-PA cohort

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Boehringer Ingelheim (China) Investment Co., ltd.

Shanghai, 200040, China

Location

Related Publications (1)

• 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. 2025 Apr 30:svn-2024-004004. doi: 10.1136/svn-2024-004004. Online ahead of print.

  PMID: 40312065 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

According to Boehringer Ingelheim's internal policy, no document date is required in the title page of the Statistical and Epidemiological Analysis Plan

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: No
• Restriction Type: OTHER
• Restrictive Agreement: 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: June 2, 2022
• Study Start: July 18, 2022
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)