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Thrombolysis Treated With TNK...

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

Last Updated: 2023-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1630 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-26

Study Completion Date

2024-03-29

Brief Summary

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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.

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Detailed Description

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The study will be a multi-center, prospective, randomized, open- label, blinded endpoint (PROBE), controlled phase 3 trial (2 arm with 1:1 randomization) in ischemic stroke patients. Imagine is performed with CT or MRI acutely with imaging follow-up at 24-36 hours. The sample size is 1630.

Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Alteplase

Patients will receive intravenous Alteplase at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as bolus and the remainder over 1 hour.

Group Type ACTIVE_COMPARATOR

Alteplase

Intervention Type DRUG

Alteplase 0.9mg/kg are being used.

Tenecteplase

Patients will receive intravenous Tenecteplase, 0.25mg/kg, maximum 25mg, administered as a bolus over 5\~10 seconds

Group Type EXPERIMENTAL

Tenecteplase

Intervention Type DRUG

Tenecteplase 0.25mg/kg are being used.

Interventions

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Alteplase

Alteplase 0.9mg/kg are being used.

Intervention Type DRUG

Tenecteplase

Tenecteplase 0.25mg/kg are being used.

Intervention Type DRUG

Other Intervention Names

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rt-PA TNK-tPA

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Yongjun Wang

President of Beijing Tiantan Hospital, Capital Medical University, Director of Neurology Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shuya Li

Role: STUDY_DIRECTOR

IRB of Beijing Tiantan Hospital,Capital Medical University

Locations

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