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NCT Number: NCT04588337

INtravenous TNK for Acute isChemicsTroke in China

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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); ;
  • Allergic to research drug;
  • Within 3 months or participating in other clinical trials;
  • Other conditions due to which investigators consider study participation inappropriate.

Treatment and study plan

rhTNK-tPA

Drug

Thrombolysis

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2020
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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