Clinical trial NCT04588337: INtravenous TNK for Acute isChemicsTroke in China
Official title: INtravenous TNK for Acute isChemicsTroke in China (INTACT-China): a Prospective, Multi-center, Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Ischemic
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: acute ischemic stroke patients who is eligible for intravenous thrombolysis

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.


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.

Primary outcomes:
measure: The proportion of excellent prognosis (mRS 0-1)
timeFrame: 90 ± 7 days
Secondary outcomes:
measure: the proportion of good prognosis (mRS 0-2)
timeFrame: 90 ± 7 days
measure: The incidence of stroke deterioration after thrombolysis
timeFrame: within 1 week
measure: the incidence of stroke recurrence and other vascular events
timeFrame: within 90 ± 7 days
measure: symptomatic intracerebral hemorrhage
timeFrame: within 36 hours
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Department of Neurology, General Hospital of Northern Theater Command
Study officials:
References: