Skip to main content
OpenTrials
Completed

NCT Number: NCT05395351

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim (China) Investment Co., ltd.

Shanghai, 200040, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

rt-PA

Drug

Intravenous recombinant tissue plasminogen activator (IV rt-PA)

Other names: Alteplase

Primary outcomes

  1. All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients

    Time frame: Up to 100 days.

    All-cause mortality during hospitalization of acute ischemic stroke (AIS) patients who received intravenous recombinant tissue plasminogen activator (IV rt-PA).

Secondary outcomes

  1. Percentage of Patients With Hemorrhagic Stroke During Hospitalization

    Time frame: Up to 100 days.

    Percentage of patients with hemorrhagic stroke during hospitalization.

  2. Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment

    Time frame: Up to 24 hours.

    The National Institutes of Health Stroke Scale (NIHSS) is a scale of stroke severity, it ranges from 0 to 42 where a score of 0 indicates no stroke symptoms and higher scores indicate incremental levels of neurologcial impairment.

  3. Modified Rankin Score (mRS) at Discharge

    Time frame: Up to 100 days.

    The Modified Rankin Score (mRS) ranges from 0 to 6, where 0 indicates no symptoms, 1 no significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability and 6 death.

  4. Number of Patients With Stroke Recurrence During Hospitalization

    Time frame: Up to 100 days.

    Number of patients with stroke recurrence during hospitalization.

  5. Length of Hospitalization

    Time frame: Up to 100 days.

    Length of hospitalization.

  6. Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Among Acute Ischemic Stroke (AIS) Patients Arrived or Were Admitted to the Hospital Within 4.5 Hours of Symptom Onset

    Time frame: Up to 4.5 hours.

    Percentage of intravenous recombinant tissue plasminogen activator (IV rt-PA) treatment among acute ischemic stroke (AIS) patients arrived or were admitted to the hospital within 4.5 hours of symptom onset.

  7. Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Within 4.5 Hours of Symptom Onset Among Eligible AIS Patients (3.5-hour Arrival or Admission)

    Time frame: Up to 4.5 hours.

    Percentage of intravenous recombinant tissue plasminogen activator (IV rt-PA) treatment within 4.5 hours of symptom onset among eligible AIS patients (3.5-hour arrival or admission).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Characteristics and In-hospital Outcomes of Chinese Elderly (>80 Years) Patients With Acute Ischemic Stroke Receiving Intravenous Recombinant Tissue Plasminogen Activator Treatment Within 4.5 Hours of Symptom Onset

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 27, 2022
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.