1-year Clinical Outcomes in Recombinant Tissue Plasminogen Activator (Rt-PA) Treated Chinese Acute Ischaemic Stroke (AIS) Patients

NCT05395338 | Completed Results

• 1 other identifier: 0135-0350
• Study Type: observational
• Target: 12,551
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to find out the 1-year clinical outcomes among Acute Ischaemic Stroke (AIS) patients who were treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset compared with those who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment in a real-world clinical setting.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• All-cause Mortality at 1 Year (Percentage of Patients With Modified Rankin Scale (mRS) Score =6)

  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. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.

  Up to 1 year.

Secondary Outcomes (4)

• Percentage of Patients With Functional Independence (mRS Score 0 to 2) at 1 Year

  Up to 1 year.

• Percentage of Patients With Favourable Outcome (mRS Score 0 to 1) at 1 Year

  Up to 1 year.

• Percentage of Patients With mRS Score 5 to 6 at 1 Year

  Up to 1 year.

• Distribution of mRS Score at 1 Year

  Up to 1 year.

Study Arms (2)

IV rt-PA cohort

Patients who received IV rt-PA within 4.5 hours of symptom onset

Drug: rt-PA

Non-reperfusion cohort

Patients who arrived or were admitted to the hospital within4.5 hours of symptom onset and did not receive any reperfusion treatment

Interventions

rt-PA DRUG

Recombinant Tissue Plasminogen Activator

IV rt-PA cohort

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

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 ZSQCC platform from Jan 2017 to Mar 2020
• ≥ 18 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 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

This was a non-interventional study (NIS) based on existing data, although Propensity Score Matching (PSM) was used, we cannot rule out the influence of other unmeasured confounding factors.

Results Point of Contact

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

clintriage.rdg@boehringer-ingelheim.com

018002430127

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: May 27, 2022
• Study Start: April 12, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: October 16, 2024
• Results First Posted: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)