INtravenous TNK for Acute isChemicsTroke in China

NCT04588337 | Completed DMC

• 1 other identifier: y2020-022
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Acute ischemic stroke is the most common type of stroke, accounting for about 60%-80% of all stroke, with high incidence, high mortality, high disability rate, has become the first cause of death in China. At present, only ultra-early thrombolytic therapy, endovascular therapy and antiplatelet therapy have obtained evidence-based medical evidence in ischemic stroke treatment, but only thrombolytic therapy and endovascular therapy can improve the good prognosis of patients. Intravenous thrombolytic therapy within 4.5 hours after the onset of ischemic stroke symptoms has been shown to be effective, which is recommended in the guidelines. In most countries, alteplase (R-tPA) is the only drug approved for the treatment of acute ischemic stroke. Recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) is a modified recombinant tissue-type plasminogen activator, with no procoagulant effect and a longer half life. In recent years, there are some studies on the comparison of therapeutic effects of TNK-tPA and RT-PA in patients with acute ischemic stroke, and TNK shows promising especially for large artery occlussion. At present, there are few reports on the application of rhTNK-tPA in Chinese stroke patients. The aim of this study is to evaluate the efficacy and safety of rhTNK-tPA in Chinese patients with ischemic stroke in a prospective, multicenter registration study.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• The proportion of excellent prognosis (mRS 0-1)

  The proportion of excellent prognosis (mRS 0-1) after thrombolysis

  90 ± 7 days

Secondary Outcomes (4)

• the proportion of good prognosis (mRS 0-2)

  90 ± 7 days

• The incidence of stroke deterioration after thrombolysis

  within 1 week

• the incidence of stroke recurrence and other vascular events

  within 90 ± 7 days

• symptomatic intracerebral hemorrhage

  within 36 hours

Interventions

rhTNK-tPA DRUG

Thrombolysis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

acute ischemic stroke patients who is eligible for intravenous thrombolysis

You may qualify if:

• Age ≥18 ;
• The time from onset to treatment was less than 4.5 hours;
• Ischemic stroke confirmed by head CT or MRI;
• There are measurable neurological deficits;
• First onset or previous onset without obvious sequelae (Mrs ≤1 score) ;
• signed informed consent.

You may not qualify if:

• Severe neurologic deficits before onset (mRS ≥2) ;
• Significant head trauma or stroke in the last 3 months;
• Subarachnoid hemorrhage;
• A history of intracranial hemorrhage or head injury or acute stroke within 3 months;
• Intracranial tumors, arteriovenous malformations or aneurysms;
• Intracranial or spinal cord surgery within 3 months;
• Non-compressible arterial puncture within 7 days;
• Gastrointestinal or urinary tract hemorrhage within last 21 days;
• Major surgery within 1 month;
• Thrombocytopenia (platelet count \<10×109/L);
• Use of heparin or oral anticoagulation therapy within 48 hours;
• Use of warfarin with an international normalised ratio \>1.7 or PT \>15 s;
• Uncontrolled hypertension (SYSTOLIC \>180 mmHg OR DIASTOLIC\>110 mmHg) ;
• The Blood Glucose concentration \<50 mg/dl (2.7 mmol/L);
• Severe systemic disease with poor life expectancy (\<3 months); ;

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

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurology

Study Record Dates

• First Submitted: October 3, 2020
• First Posted: October 19, 2020
• Study Start: January 6, 2022
• Primary Completion: April 9, 2024
• Study Completion: April 9, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

CN (1)