Acute Ischemic Stroke
Conditions
Keywords
rhTNK-tPA, acute, stroke, phaseⅢ, Acute Ischemic Stroke, rt-PA
Brief summary
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
Detailed 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.
Interventions
Sponsors
CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
multicenter, prospective, randomized, open label, blinded-endpoint (PROBE)，Parallel controls，Non-inferiority
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Excellent functional outcome | 90 days | Proportion of subjects with mRS(0-1) at 90 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Good functional outcome | 90 days | Proportion of subjects with mRS(0-2) at 90 days. |
| National Institutes of Health Stroke Scale (NIHSS) | 24 hours，day7 | Proportion of subjects with NIHSS score ≥ 4 improved compared with baseline at 24 or with NIHSS 0-1 at 24 hours and 7 days. |
| EQ-5D | 90 days | Quality of life measured by EQ-5D scale. |
| Barthel (BI) | 90 days | Global function of daily living defined as BI ≥ 95 at 90 days. |
| Modified Rankin Scale(mRS) | 90 days | Ordinal distribution of mRS at 90 days. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic intracranial hemorrhage(sICH) | 36 hours | Proportion of subjects with symptomatic intracranial hemorrhage (sICH) at 36 hours.( defined by ECASSIII) |
| AEs/SAEs | 90 days | The incidence of adverse events(AEs) / severe adverse events(SAEs) at 90 days. |
| Asymptomatic intracranial hemorrhage | 90 days | The incidence of asymptomatic intracranial hemorrhage at 90 days. |
| PH2 intracranial hemorrhage | 90 days | The incidence of PH2 intracranial hemorrhage within 90 days (according to SITS standards). |
| Any intracranial hemorrhage | 90 days | The incidence of any intracranial hemorrhage within 90 days. |
| Systematic bleeding | 90 days | The incidence of Systematic bleeding at 90 days.( defined by GUSTO） |
| Deaths | 90 days | Rate of Overall mortality at 90 days. |
Countries
China
Outcome results
None listed