N/A N=42,188

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;

Stroke

Bottom Line

View on ClinicalTrials.gov: NCT04290494 ↗

Enrolled (actual)

42,188

Serious AEs

—

Results posted

Nov 2021

Primary outcome: Primary: 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 — 11.66; 10.66; 28.77 Percentage of participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: IV rtPA (intravenous recombinant plasminogen activator) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Sep 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	11.66; 10.66; 28.77	—
PRIMARY 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	13.53; 7.11; 33.44	—
SECONDARY 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	0.92; 1.32; 3.61	—
SECONDARY 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	1.57; 1.47; 6.96	—
SECONDARY 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	90.0; 100.0; 58.0	—
SECONDARY 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	28.71; 12.29; 59.21	—
SECONDARY Time Between Symptom Onset and Arrival at Hospital Among 3 Hours Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treated Patients	60.0; 59.0; 69.0	—
SECONDARY Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 3 Hours IV-rtPA Treated Patients	150.0; 156.0; 134.0	—
SECONDARY 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	94.0; 95.0; 60.0	—
SECONDARY 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	26.74; 13.36; 53.43	—
SECONDARY Time Between Symptom Onset and Arrival at Hospital Among 4.5 Hours Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treated Patients	75.0; 59.0; 100.0	—
SECONDARY Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 4.5 Hours IV-rtPA Treated Patients	175.0; 159.0; 170.0	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04290494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.