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Completed

NCT Number: NCT05401149

Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients

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.

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Key information

Conditions

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

Age range

80 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

  • 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

Treatment and study plan

rt-PA

Drug

Recombinant Tissue Plasminogen Activator

Primary outcomes

  1. Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year

    Time frame: 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).

    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.

    • - No significant disability.
    • - Slight disability.
    • - Moderate disability.
    • - Moderately severe disability.
    • - Severe disability.
    • - 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.

Secondary outcomes

  1. Percentage of Patients With Any Intracranial Haemorrhage (ICH) During Hospitalisation

    Time frame: Up to 3 months

    Percentage of patients with any intracranial haemorrhage (ICH) during hospitalisation.

    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 NIHSS score, and time from symptom onset to hospital admission.

  2. All-cause Mortality During Hospitalisation

    Time frame: Up to 3 months

    All-cause mortality during hospitalisation.

    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 NIHSS score, and time from symptom onset to hospital admission.

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

    Time frame: 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).

    Percentage of patients with independence (modified Rankin Scale (mRS) 0-2) 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.
    • - Slight disability.
    • - Moderate disability.
    • - Moderately severe disability.
    • - Severe disability.
    • - 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.

  4. Distribution of Modified Rankin Scale (mRS) Score at 1 Year

    Time frame: 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.

    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.
    • - Slight disability.
    • - Moderate disability.
    • - Moderately severe disability.
    • - Severe disability.
    • - 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.

  5. All-cause Mortality at 1 Year

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 2, 2022
Registry last updated
Oct 17, 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.

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