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

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05395338

Collaborator

(none)

11,700

Enrollment

Location

5.6

Anticipated Duration (Months)

2082.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Drug: rt-PA

Study Design

Study Type:

Observational

Actual Enrollment :

11700 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

1-year Clinical Outcomes After Intravenous Rt-PA for Chinese AIS Patients

Actual Study Start Date :

Apr 12, 2022

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
IV rt-PA cohort Patients who received IV rt-PA within 4.5 hours of symptom onset	Drug: rt-PA Recombinant Tissue Plasminogen Activator
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

Arm

Intervention/Treatment

IV rt-PA cohort

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

Drug: rt-PA

Recombinant Tissue Plasminogen Activator

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

Outcome Measures

Primary Outcome Measures

All-cause mortality at 1 year (modified Rankin Scale (mRS) score =6) [up to 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. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead.

Secondary Outcome Measures

mRS score 0-2 at 1 year [up to 1 year]
mRS score 0-1 at 1 year [up to 1 year]
mRS score 5-6 at 1 year [up to 1 year]
Distribution of mRS score at 1 year [up to 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

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

Exclusion criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boehringer Ingelheim (China) Investment Co., ltd.	Shanghai		China	200040

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT05395338

Other Study ID Numbers:

0135-0350

First Posted:

May 27, 2022

Last Update Posted:

Aug 11, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Aug 11, 2022