INtravenous TNK for Acute isChemicsTroke in China

NCT ID: NCT04588337

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-06
• Study Completion Date: 2024-04-09

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

rhTNK-tPA

Thrombolysis

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Head of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, , China

Countries

China

Other Identifiers

y2020-022

Identifier Type: -

Identifier Source: org_study_id