MRI-guided thrOmbolysis for Stroke bEyond Time Window by TNK

NCT04752631 | Completed Phase 4 DMC

• 1 other identifier: Y(2020)067
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label multicentre trial, evaluating the utility of MRI-guided thrombolysis for stroke beyond time window by Tenecteplase (TNK-tPA). This exploratory study was to describe the feasibility and outcome of thrombolytic therapy with TNK-tPA in 4.5-24 hours after stroke guided by a mismatch between diffusion-weighted imaging and FLAIR in the region of ischemia.

Conditions

Stroke

Keywords

TNK-tPA; stroke

Outcome Measures

Primary Outcomes (1)

• Proportion of modified Rankin Scale (mRS) 0-1

  the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome

  90 Days

Secondary Outcomes (5)

• Proportion of modified Rankin Scale (mRS) 0-2

  90 Days

• Distribution of the modified Rankin Scale (mRS)

  90 Days

• Changes in National Institute of Health stroke scale (NIHSS)

  24 hours and 1 week

• vascular events

  90 Days

• proportion of death

  14 days

Other Outcomes (4)

• Proportion of symptomatic intracranial hemorrhage (sICH)

  48 hours

• Proportion of intraparenchymal hemorrhage (PH1 and PH2)

  48 hours

• proportion of hemorrhagic transformation

  7 Days

Study Arms (2)

TNK-tPA

EXPERIMENTAL

TNK-tPA (0.25mg/kg) given as a single bolus over 5-10 seconds immediately upon randomization.

Drug: Tenecteplase

Routine Therapy

NO INTERVENTION

Patients will be treated with standard of care in compliance with guidelines for acute stroke

Interventions

Tenecteplase DRUG

The participants received TNK-tPA thrombolytic therapy

Also known as: TNK-tPA

TNK-tPA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age 18-80 years;
• The time from onset to treatment: 4.5-24 hours;
• Acute Ischemic stroke confirmed by MRI;
• NIHSS score ：6-25, or NIHSS score≤ 5 but culprit vessel occlusion or severe stenosis ( ICA, MCA-M1/M2, ACA) on CTA/MRA;
• Imaging requirements: (1) DWI infarct region: no more than 1/3 of middle cerebral artery territory or 1/2 of the anterior cerebral artery territory or 1/2 of the posterior cerebral artery territory; (2) DWI infarct volume \<70 ml; (2) presence of DWI/Flair mismatch: DWI high signal and Flair visually normal;
• the first onset of ischemic stroke or previous stroke with no obvious sequelae (mRS≤1);
• Signed informed consent

You may not qualify if:

• Planned endovascular treatment;
• Serious neurological deficits before onset ( mRS ≥ 2);
• Obvious head injuries or strokes within 3 months;
• Subarachnoid hemorrhage;
• History of intracranial hemorrhage;
• Intracranial tumor, arteriovenous malformation or aneurysm;
• Intracranial or spinal cord surgery within 3 months;
• Arterial puncture at a noncompressible site within the previous seven days;
• Active internal hemorrhage;
• coagulation abnormalities: platelet count of \<100000/mm3 ；
• Aortic arch dissection；
• Heparin therapy within 24 hours;
• Infective endocarditis；
• Oral warfarin is being taken and INR\>1.6 or APTT abnormal；
• oral anticoagulation therapy；

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Location

Related Publications (1)

• Thomalla G, Simonsen CZ, Boutitie F, Andersen G, Berthezene Y, Cheng B, Cheripelli B, Cho TH, Fazekas F, Fiehler J, Ford I, Galinovic I, Gellissen S, Golsari A, Gregori J, Gunther M, Guibernau J, Hausler KG, Hennerici M, Kemmling A, Marstrand J, Modrau B, Neeb L, Perez de la Ossa N, Puig J, Ringleb P, Roy P, Scheel E, Schonewille W, Serena J, Sunaert S, Villringer K, Wouters A, Thijs V, Ebinger M, Endres M, Fiebach JB, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Gerloff C; WAKE-UP Investigators. MRI-Guided Thrombolysis for Stroke with Unknown Time of Onset. N Engl J Med. 2018 Aug 16;379(7):611-622. doi: 10.1056/NEJMoa1804355. Epub 2018 May 16.

  PMID: 29766770 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Tenecteplase; TNK-tissue plasminogen activator

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Chen Hui-Sheng, Doctor

  General Hospital of Shenyang Military Region

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Outcomes will be performed by a blinded assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of neurology department

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 12, 2021
• Study Start: March 9, 2021
• Primary Completion: July 24, 2022
• Study Completion: July 24, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)