INtravenous TNK for Acute isChemicsTroke in China

INtravenous TNK for Acute isChemicsTroke in China (INTACT-China): a Prospective, Multi-center, Registry Study

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Drug: rhTNK-tPA

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• China
  • Shenyang, China, 110016
    • Recruiting
    • Department of Neurology, General Hospital of Northern Theater Command
    • Contact: Hui-Sheng Chen, Ph.D.; Phone Number: +86 13352452086; Email: chszh@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

acute ischemic stroke patients who is eligible for intravenous thrombolysis

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Severe neurologic deficits before onset (mRS ≥2) ;
2. Significant head trauma or stroke in the last 3 months;
3. Subarachnoid hemorrhage;
4. A history of intracranial hemorrhage or head injury or acute stroke within 3 months;
5. Intracranial tumors, arteriovenous malformations or aneurysms;
6. Intracranial or spinal cord surgery within 3 months;
7. Non-compressible arterial puncture within 7 days;
8. Gastrointestinal or urinary tract hemorrhage within last 21 days;
9. Major surgery within 1 month;
10. Thrombocytopenia (platelet count <10×109/L);
11. Use of heparin or oral anticoagulation therapy within 48 hours;
12. Use of warfarin with an international normalised ratio >1.7 or PT >15 s;
13. Uncontrolled hypertension (SYSTOLIC >180 mmHg OR DIASTOLIC>110 mmHg) ;
14. The Blood Glucose concentration <50 mg/dl (2.7 mmol/L);
15. Severe systemic disease with poor life expectancy (<3 months); ;
16. Allergic to research drug;
17. Within 3 months or participating in other clinical trials;
18. Other conditions due to which investigators consider study participation inappropriate.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of excellent prognosis (mRS 0-1)	The proportion of excellent prognosis (mRS 0-1) after thrombolysis	90 ± 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the proportion of good prognosis (mRS 0-2)	The proportion of good prognosis (mRS 0-2) after thrombolysis	90 ± 7 days
The incidence of stroke deterioration after thrombolysis	NIHSS score increased by more than 2, excluding cerebral hemorrhage	within 1 week
the incidence of stroke recurrence and other vascular events	the incidence of stroke recurrence and other vascular events within 90 ± 7 days after thrombolysis	within 90 ± 7 days
symptomatic intracerebral hemorrhage	any evidence of bleeding on the head CT scan associated with clinically significant neurological deterioration (NIHSS score ≥4 points increase)	within 36 hours

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2022
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: October 3, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: y2020-022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No