Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-

  • STATUS
    Recruiting
  • End date
    Oct 31, 2023
  • participants needed
    1430
  • sponsor
    Beijing Tiantan Hospital
Updated on 5 August 2021

Summary

A Phase , Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Injection Versus Alteplase for Acute Ischemic Stroke Within 4.5 Hours

Description

To test the hypothesis that rhTNK-tPA is non-inferior to alteplase in thrombolysis treatment when administered within 4.5 hours of ischemic stroke onset.

Details
Condition Acute Ischemic Stroke
Treatment rt-PA, rhTNK-tPA
Clinical Study IdentifierNCT04797013
SponsorBeijing Tiantan Hospital
Last Modified on5 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years old, no gender limitation
The time from onset to treatment was < 4.5h;The time at which symptoms begin is defined as "the time at which they finally appear normal
The clinical diagnosis was ischemic stroke (the diagnosis followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018)
MRS before onset was 0-1 points
Baseline NIHSS 5-25(both included)
Informed consent from the patient or surrogate

Exclusion Criteria

Intended to proceed endovascular treatment
NIHSS consciousness score >2
Allergy to tenecteplase or alteplase
Past history of intracranial hemorrhage
A history of severe head trauma or stroke within 3 months
A history of intracranial or spinal surgery within 3 months
A history of gastrointestinal or urinary bleeding within 3 weeks
weeks of major surgery
Arterial puncture was performed at the hemostasis site that was not easily compressed within 1 week
Intracranial tumors (except neuroectodermal tumors, such as meningiomas), large intracranial aneurysms
Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.)
Active visceral bleeding
Aortic arch dissection was found
After active antihypertensive treatment, hypertension is still not under control: systolic blood pressure 180 mm Hg, or diastolic blood pressure 100 mm Hg
Propensity for acute bleeding, including platelet counts of less than 100109/ L or otherwise
Blood glucose <2.8 mmol/L or >22.22 mmol/L
Oral warfarin anticoagulant with INR>1.7 or PT>15 s
Heparin treatment was received within 24 h
Thrombin inhibitors or factor Xa inhibitors were used within 48 h
Head CT or MRI showed a large infarction (infarcted area > 1/3 of the middle cerebral artery)
Subjects who are unable or unwilling to cooperate due to hemiplegia (Todd's palsy) after epileptic seizure or other neurological/psychiatric disorders
Pregnant women, lactating women, or subjects who do not agree to use effective contraception during the trial
Participation in other clinical trials within 3 months prior to screening
Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk
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