INtravenous TNK for Acute isChemicsTroke in China

• ClinicalTrials.gov Identifier: NCT04588337
• Recruitment Status: Recruiting
• First Posted: October 19, 2020
• Last Update Posted: January 28, 2022
• Sponsor: General Hospital of Shenyang Military Region
• Information provided by (Responsible Party): Hui-Sheng Chen, General Hospital of Shenyang Military Region

Study Description

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.

Condition or disease	Intervention/treatment
Stroke, Ischemic	Drug: rhTNK-tPA

Study Design

• Study Type: Observational
• Estimated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: INtravenous TNK for Acute isChemicsTroke in China (INTACT-China): a Prospective, Multi-center, Registry Study
• Actual Study Start Date: January 6, 2022
• Estimated Primary Completion Date: December 30, 2022
• Estimated Study Completion Date: December 30, 2022

Groups and Cohorts

Intervention Details:

• Drug: rhTNK-tPA
  Thrombolysis

Outcome Measures

Primary Outcome Measures :

1. The proportion of excellent prognosis (mRS 0-1) [ Time Frame: 90 ± 7 days ]
   The proportion of excellent prognosis (mRS 0-1) after thrombolysis

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

acute ischemic stroke patients who is eligible for intravenous thrombolysis

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.

Contacts and Locations

Locations

China

Department of Neurology, General Hospital of Northern Theater Command; Recruiting

Shenyang, China, 110016

Contact: Hui-Sheng Chen, Ph.D. +86 13352452086 chszh@aliyun.com

Sponsors and Collaborators

General Hospital of Shenyang Military Region

More Information

• Responsible Party: Hui-Sheng Chen, Head of Neurology, General Hospital of Shenyang Military Region
• ClinicalTrials.gov Identifier: NCT04588337
• Other Study ID Numbers: y2020-022
• First Posted: October 19, 2020
• Last Update Posted: January 28, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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