Clinical trial 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;
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-03-02
Enrollment: 42188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All eligible patients from the CNSR I to III will be included. Patient groups include the overall AIS patients (patient group A), IVT eligible patients (patient groups B and B'), and IV rtPA treated patients (patient groups C and C').

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: From 2007 to 2017, up to 10 years before this study started.
measure: 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
timeFrame: From 2007 to 2017, up to 10 years before this study started.
Secondary outcomes:
measure: 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
timeFrame: From 2007 to 2017, up to 10 years before this study started.
measure: 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
timeFrame: From 2007 to 2017, up to 10 years before this study started.
measure: 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
timeFrame: From arrival at the hospital until the administration of Intravenous Recombinant Plasminogen Activator, up to 170 minutes.
measure: 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
timeFrame: From 2007 to 2017, up to 10 years before this study started.
measure: Time Between Symptom Onset and Arrival at Hospital Among 3 Hours Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treated Patients
timeFrame: From symptom onset until arrival at the hospital, up to 120 minutes.
measure: Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 3 Hours IV-rtPA Treated Patients
timeFrame: From symptom onset until administration of Intravenous Recombinant Plasminogen Activator, up to 180 minutes.
measure: 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
timeFrame: From arrival at the hospital until the administration of Intravenous Recombinant Plasminogen Activator, up to 247 minutes.
measure: 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
timeFrame: From 2007 to 2017, up to 10 years before this study started.
measure: Time Between Symptom Onset and Arrival at Hospital Among 4.5 Hours Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treated Patients
timeFrame: From symptom onset until arrival at the hospital, up to 210 minutes.
measure: Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 4.5 Hours IV-rtPA Treated Patients
timeFrame: From symptom onset until the administration of Intravenous Recombinant Plasminogen Activator, up to 270 minutes.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
References: