Overview

Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients (3T Stroke-Ⅲ)

Status:
Recruiting
Trial end date:
2024-03-29
Target enrollment:
0
Participant gender:
All
Summary
The trial is prospective, randomized, open-label, blinded endpoint (PROBE) design. Patients with acute ischemic stroke, who are eligible for standard intravenous thrombolysis within 4.5 hours of stroke onset will be randomized 1:1 to 0.25mg/kg or 0.9 mg/kg alteplase before all participants undergo endovascular thrombectomy.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beijing Tiantan Hospital
Collaborators:
Jiangsu FENG HUA Biotech Pharmaceutical Co., Ltd
The Place Pharmaceutical(Jiangsu) Co., Ltd
Treatments:
Tenecteplase
Tissue Plasminogen Activator
Criteria
Inclusion Criteria:

- 18≤Age≤80 years old;

- The clinical diagnosis was Acute ischemic stroke 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";

- MRS before onset was ≤1 points;

- Baseline NIHSS (at the time of randomization) should be ≥5 and ≤25 points;

- Informed consent from the patient or surrogate.

Exclusion Criteria:

- Intracranial hemorrhage identified by CT or MRI (CMBs detected by SWI is not counted);

- Massive anterior cerebral infarction identified by CT or MRI (ASPECT < 6 or lesions
larger than one third of the territory of the middle cerebral artery or with a volume
larger than 70mL)

- Patients planning to receive endovascular therapy

- A history of severe CNS damage (such as aneurysm or arteriovenous malformation,
craniocerebral trauma, intracranial or spinal cord surgery)

- Onset with seizures, and the paralysis was suspected to be related to Todd paralysis.

- Administration of heparin within 48 hours preceding the onset of stroke with a
baseline APTT exceeding the upper limit of the normal range.

- Oral anticoagulant (such as warfarin) treatment with baseline INR>1.7 or PT>15 s;

- Administration of thrombin inhibitors or factor Xa inhibitors within 48 hours
preceding the onset of stroke with abnormal coagulation parameters or platelet count;

- BP couldn't be controlled with aggressive treatment. Uncontrolled hypertension was
defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg,
measured for three times every 10 minutes.

- Platelet count of less than 100×109/ L;

- Blood glucose <50 mg/dl (<2.8 mmol/L) or >400 mg/dl (22.22 mmol/L);

- History of intracranial hemorrhage or active hemorrhagic disease. (Such as
gastrointestinal, urinary tract or retinal bleeding)

- Tumors with an increased risk of bleeding.

- Prolonged or traumatic cardiopulmonary resuscitation (>2 min), delivery within the
last 10 days or recent puncture of non-compression vessels such as subclavian vein or
jugular vein

- Acute pancreatitis or severe liver disease, including liver failure, cirrhosis, portal
hypertension, esophageal varicose veins, and active hepatitis;

- Aortic arch dissection;

- Major surgery or severe trauma in the past 2 weeks;

- Subjects had serious, fatal, or disabling disease with an expected survival of less
than 3 months;

- Unable to complete neurological assessment and follow-up visits because of dementia or
mental illness;

- Pregnant women, lactating women, or have positive pregnancy test;

- Allergy to tenecteplase or alteplase or their components;

- Participation in other clinical trials within 3 months prior to screening;

- Unsuitable to involve in this study or would result in increased risk, as judged by
the investigators.