Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients

Stroke Clinical Trial

Official title:

Effectiveness and Safety of IV Rt-PA Treatment in Chinese AIS Patients Aged Above 80 Years: a Real-world Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05401149
• Other study ID #: 0135-0349
• Status: Completed
• Start date: July 18, 2022
• Est. completion date: December 14, 2022

Study information

• Verified date: December 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1301
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

Inclusion criteria:

• 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

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

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• rt-PA
Recombinant Tissue Plasminogen Activator

Locations

Country	Name	City	State
China	Boehringer Ingelheim (China) Investment Co., ltd.	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin Scale (mRS) score of 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.; - 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.	up to 1 year
Secondary	Intracranial haemorrhage (ICH) during hospitalisation		up to 3 months
Secondary	All-cause mortality during hospitalisation		up to 3 months
Secondary	mRS score of 0-2 at 1 year		up to 1 year
Secondary	Distribution of mRS score at 1 year		up to 1 year
Secondary	All-cause mortality at 1 year		up to 1 year
Secondary	Baseline characteristics: Age		at baseline
Secondary	Baseline characteristics: Gender		at baseline
Secondary	Baseline characteristics: Body weight		at baseline
Secondary	Baseline characteristics: Medical insurance status	urban employee basic medical insurance, urban resident basic medical insurance, new rural cooperative medical insurance, other insurance, no insurance	at baseline
Secondary	Baseline characteristics: Smoking status	current smoker, former smoker, never smoker	at baseline
Secondary	Baseline characteristics: Stroke severity	Stroke severity is measured via the National Institutes of Health Stroke Scale (NIHSS). The NIHSS score ranges from 0 to 42. Higher scores indicate more severe neurological impairment.	at baseline
Secondary	Baseline characteristics: Time from symptom onset to hospital admission		at baseline
Secondary	Baseline characteristics: Time from symptom onset to treatment	for patients in the IV rt-PA cohort	at baseline
Secondary	Baseline characteristics: Time from hospital admission to treatment	for patients in the IV rt-PA cohort	at baseline
Secondary	Baseline characteristics: rt-PA dosage	for patients in the IV rt-PA cohort	at baseline
Secondary	Baseline characteristics: Number of subjects with Comorbidities		at baseline
Secondary	Baseline characteristics: Number of subjects with Co-medication		at baseline
Secondary	Baseline characteristics: Hospital level (grade 2 or 3)		at baseline

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