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Completed

NCT Number: NCT04290494

Temporal Trends of Thrombolysis Treatment in Chinese Acute Ischemic Stroke (AIS) Patients From 2007-2017: Analysis of China National Stroke Registry (CNSR) I, II, and III; CTP-Draft Review Performed;

The present study is to be conducted based on the AIS patient data collected from CNSR I, II, and III.

The primary objectives are:

* To investigate the temporal changes in the proportion of intravenous recombinant plasminogen activator (IV rtPA) treatment from 2007 to 2017 among Intravenous Thrombolytics (IVT) eligible patients (patient groups B and B') and overall AIS patients (patient group A) in China; * To investigate the temporal changes in IV rtPA treatment time intervals from 2007 to 2017 among IV rtPA treated patients (patient groups C and C') in China.

The secondary objectives are:

- To describe the demographic and clinical characteristics of the IV rtPA treated patients (patient groups C and C'), IVT eligible patients (patient groups B and B') and the overall AIS patients (patient group A) from 2007 to 2017 from the CNSR I to III.

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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

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tiantan Hospital

Beijing, 100070, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient group A: All AIS patients
  • Aged 18 80 years
  • Diagnosed with AIS on admission
  • Patient groups B and B': IVT eligible patients
  • Met the in- and exclusion criteria of "all AIS patients"
  • Arrived at hospital within 2 h (patient group B) or 3.5 h (patient group B') of symptom onset
  • Patient groups C and C': IV rtPA treated patients
  • Met the in- and exclusion criteria of "IVT eligible patients"
  • Treated with IV rtPA within 3 h (patient group C) or 4.5 h (patient group C') of symptom onset

Exclusion criteria

  • Patient group A: All AIS patients
  • Missing baseline data including age and gender
  • Diagnosed with intracranial hemorrhage (ICH), Transient Ischemic Attack (TIA), subarachnoid hemorrhage (SAH), or unspecific stroke
  • Arrived at hospital after 7 days of symptom onset
  • Patient groups B and B': IVT eligible patients
  • Missing key data including:

i. symptom onset time (or last known well time) ii. hospital arrival time iii. whether received IVT treatment or not iv. the time of IVT treatment

  • Documented IVT absolute contraindications, according to the case report form (CRF) for each wave of CNSR
  • Patient groups C and C': IV rtPA treated patients
  • Not received IVT
  • Received IVT other than rtPA
  • Treated with IV rtPA after 3 h (patient group C) or 4.5 h (patient group C') of symptom onset
  • Received additional treatments with intra arterial reperfusion or experimental therapies

Treatment and study plan

IV rtPA (intravenous recombinant plasminogen activator)

Drug

intravenous injection

Primary outcomes

  1. Percentage of Patients Who Received Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Within 3 Hours of Symptom Onset Among 2 Hours Intravenous Thrombolytics (IVT) Eligible Patients

    Time frame: From 2007 to 2017, up to 10 years before this study started.

    The percentage of patients who received Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment within 3 hours of symptom onset among patients eligible for intravenous thrombolytics (IVT) who arrived at the hospital within 2 hours since symptom onset was reported.

  2. Percentage of Patients Who Received Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Within 4.5 Hours of Symptom Onset Among 3.5 Hours Intravenous Thrombolytics (IVT) Eligible Patients

    Time frame: From 2007 to 2017, up to 10 years before this study started.

    The percentage of patients who received Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment within 4.5 hours of symptom onset among patients eligible for intravenous thrombolytics (IVT) who arrived at the hospital within 3.5 hours since symptom onset was reported.

Secondary outcomes

  1. Percentage of Patients Who Arrived at Hospital Within 2 Hours of Symptom Onset and Who Received Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Within 3 Hours of Symptom Onset Among All Eligible Patients

    Time frame: From 2007 to 2017, up to 10 years before this study started.

    Percentage of patients who arrived at hospital within 2 hours of symptom onset and who received Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment within 3 hours of symptom onset among all eligible patients was reported.

  2. Percentage of Patients Who Arrived at Hospital Within 3.5 Hours of Symptom Onset and Who Received Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Within 4.5 Hours of Symptom Onset Among All Eligible Patients

    Time frame: From 2007 to 2017, up to 10 years before this study started.

    Percentage of patients who arrived at hospital within 3.5 hours of symptom onset and who received Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment within 4.5 hours of symptom onset among all eligible patients was reported.

  3. The Door to Needle (DTN) Time (Time Between Arrival at Hospital and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment) Among 3 Hours IV-rtPA Treated Patients

    Time frame: From arrival at the hospital until the administration of Intravenous Recombinant Plasminogen Activator, up to 170 minutes.

    The door to needle (DTN) time (time between arrival at hospital and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment) among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset was reported.

  4. Percentage of Patients With Door to Needle (DTN) Time (Time Between Arrival at Hospital and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment) ≤ 60 Minutes Among 3 Hours IV-rtPA Treated Patients

    Time frame: From 2007 to 2017, up to 10 years before this study started.

    The percentage of patients with door to needle (DTN) time (time between arrival at hospital and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment) ≤ 60 minutes among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset was reported.

  5. Time Between Symptom Onset and Arrival at Hospital Among 3 Hours Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treated Patients

    Time frame: From symptom onset until arrival at the hospital, up to 120 minutes.

    Time between symptom onset and arrival at hospital among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset was reported.

  6. Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 3 Hours IV-rtPA Treated Patients

    Time frame: From symptom onset until administration of Intravenous Recombinant Plasminogen Activator, up to 180 minutes.

    Time between symptom onset and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset was reported.

  7. The Door to Needle (DTN) Time (Time Between Arrival at Hospital and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment) Among 4.5 Hours IV-rtPA Treated Patients

    Time frame: From arrival at the hospital until the administration of Intravenous Recombinant Plasminogen Activator, up to 247 minutes.

    The door to needle (DTN) time (time between arrival at hospital and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment) among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset was reported.

  8. Percentage of Patients With Door to Needle (DTN) Time (Time Between Arrival at Hospital and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment) ≤ 60 Minutes Among 4.5 Hours IV-rtPA Treated Patients

    Time frame: From 2007 to 2017, up to 10 years before this study started.

    The percentage of patients with door to needle (DTN) time (time between arrival at hospital and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment) ≤ 60 minutes among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset was reported.

  9. Time Between Symptom Onset and Arrival at Hospital Among 4.5 Hours Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treated Patients

    Time frame: From symptom onset until arrival at the hospital, up to 210 minutes.

    Time between symptom onset and arrival at hospital among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset was reported

  10. Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 4.5 Hours IV-rtPA Treated Patients

    Time frame: From symptom onset until the administration of Intravenous Recombinant Plasminogen Activator, up to 270 minutes.

    Time between symptom onset and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset was reported

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Temporal Trends of Thrombolysis Treatment in Chinese Acute Ischemic Stroke (AIS) Patients From 2007 2017: Analysis of China National Stroke Registry (CNSR) I, II, and III

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 2, 2020
Registry last updated
Nov 5, 2021

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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