NCT02854592: INTRECIS

Intravenous Thrombolysis Registry for Chinese Ischemic Stroke Within 4.5 h Onset

Completed Last updated 17 December 2019

What this trial tests

trial testing rtPA in Ischemic Stroke in 4,000 participants. Completed in 30 October 2019.

Timeline

1 April 2017

Primary endpoint
30 October 2019

30 October 2019

Quick facts

Lead sponsor	General Hospital of Shenyang Military Region
Status	Completed
Study type	OBSERVATIONAL
Enrollment	4,000
Start date	1 April 2017
Primary completion	30 October 2019
Estimated completion	30 October 2019
Sites	1 location across China

Drugs / interventions tested

• rtPA — full drug profile →
• urokinase — full drug profile →

Conditions studied

• Ischemic Stroke — all drugs for Ischemic Stroke →

Sponsor

General Hospital of Shenyang Military Region

Who can join

18 and older, any sex, with Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Stroke is one of the leading causes of death and disability in China. Intravenous thrombolysis with recombinant tissue plasminogen activator (rtPA) improves the outcome for ischemic stroke patients who can be treated within 4.5 hours of symptom onset. In China, in addition to rt-PA, intravenous urokinase within 6 h has also been recommended by the 2010 Chinese Guidelines for the Diagnosis and Treatment of Patients with Acute Ischemic Stroke, and supported by evidence from two intravenous urokinase thrombolysis trials. Urokinase is used more frequently than rt-PA, mainly because it is cheaper. To describe Chinese experience with thrombolytic therapy for Ischemic Stroke within 4.5h onset, we designed a multicenter, prospective, registry study. The aim of INtravenous Thrombolysis REgistry for Chinese Ischemic Stroke within 4.5 h onset（INTRECIS）was to assess the safety and efficacy of intravenous rtPA, urokinase as thrombolytic therapy within the first 4.5 h of onset of acute ischaemic stroke.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Urokinase Plasminogen Activator: A Potential Thrombolytic Agent for Ischaemic Stroke.
   Kadir RRA, Bayraktutan U. · · 2020 · cited 40× · PMID 31552559 · DOI 10.1007/s10571-019-00737-w
2. Effectiveness of intravenous r-tPA versus UK for acute ischaemic stroke: a nationwide prospective Chinese registry study.
   Wang X, Li X, Xu Y, Li R, et al · · 2021 · cited 32× · PMID 33903179 · DOI 10.1136/svn-2020-000640
3. Early neurological deterioration after intravenous thrombolysis of anterior vs posterior circulation stroke: a secondary analysis of INTRECIS.
   Cui Y, Meng WH, Chen HS. · · 2022 · cited 18× · PMID 35210531 · DOI 10.1038/s41598-022-07095-6
4. Neutrophil-to-lymphocyte ratio and its changes predict the 3-month outcome and mortality in acute ischemic stroke patients after intravenous thrombolysis.
   Wu Q, Chen HS. · · 2023 · cited 11× · PMID 37469299 · DOI 10.1002/brb3.3162
5. Change of Serum Biomarkers to Post-Thrombolytic Symptomatic Intracranial Hemorrhage in Stroke.
   Cui Y, Wang XH, Zhao Y, Chen SY, et al · · 2022 · cited 6× · PMID 35720096 · DOI 10.3389/fneur.2022.889746
6. Association of serum biomarkers with early neurologic improvement after intravenous thrombolysis in ischemic stroke.
   Cui Y, Wang XH, Zhao Y, Chen SY, et al · · 2022 · cited 4× · PMID 36315566 · DOI 10.1371/journal.pone.0277020
7. Intravenous thrombolysis with 0.65 mg/kg r-tPA may be optimal for Chinese mild-to-moderate stroke.
   Cui Y, Yao ZG, Chen HS. · · 2022 · cited 2× · PMID 36203975 · DOI 10.3389/fneur.2022.989907
8. Association of Serum Biomarkers with Post-Thrombolytic Early Neurological Improvement in Stroke: A Comprehensive Protein Microarray Analysis From INTRECIS Study
   Cui Y, Wang X, Zhao Y, Chen S, et al · · 2022 · DOI 10.21203/rs.3.rs-1226540/v1