Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅱ (TRACEⅡ)

Capital Medical University

Status and phase

Completed

Phase 3

Conditions

Acute Ischemic Stroke

Treatments

Drug: rhTNK-tPA

Drug: rt-PA

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04797013

MK02-2020-01

Details and patient eligibility

About

A Phase Ⅲ, 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

Full 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.

Enrollment

1,430 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;
2 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 100×109/ 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.