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

March 16, 2022 updated by: Yongjun Wang, Beijing Tiantan Hospital

Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients: a Multi-center, Block Randomized, Positive Drug Parallel Controlled Phase II Trial

The trial is prospective, block 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 1:1:1 to 0.25mg/kg or 0.40mg/kg intravenous tenecteplase or 0.9 mg/kg alteplase before all participants undergo endovascular thrombectomy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will be a multi-center, prospective, randomized, open- label, blinded endpoint (PROBE), controlled phase 2 trial (3 arm with 1:1:1 randomization) in ischemic stroke patients. Imagine is performed with CT or MRI acutely with imaging follow-up at 24-30 hours. The sample size is 225.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
225

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Beijing Tiantan Hospital, Capital Medical University Beijing
    • Fujian
      • Quanzhou, Fujian, China, 362000
        • Quanzhou First Hospital
    • Guangdong
      • Shaoguan, Guangdong, China, 512000
        • Yue Bei People's Hospital
    • Hebei
      • Hengshui, Hebei, China, 053000
        • Hengshui People's Hospital (Harrison International Peace Hospital)
      • Tangshan, Hebei, China, 063000
        • Tangshan Gongren Hospital
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163000
        • Daqing Oilfield General Hospital
    • Inner Monglia
      • Baotou, Inner Monglia, China, 014010
        • Baogang Hospital of Inner Monglia
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014040
        • Inner Mongolia Baotou Hospital
    • Jiangsu
      • Huai'an, Jiangsu, China, 121000
        • Huai'an Second People's Hospital
      • Xuzhou, Jiangsu, China, 221006
        • The Affiliated Hospital of Xuzhou Meidcal University
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
      • Meihekou, Jilin, China, 135000
        • Mei he kou central hospital
      • Siping, Jilin, China, 136100
        • Jilin Guowen Hospital
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • General Hospital of Ningxia Medical University
      • Yinchuan, Ningxia, China, 750001
        • The First People's Hospital of Yinchuan
    • Shandong
      • Jinan, Shandong, China, 250000
        • Shandong Provincial Third Hospital
      • Liaocheng, Shandong, China, 252006
        • Liaocheng People's Hospital
      • Linyi, Shandong, China, 276000
        • Linyi City People Hospital
      • Qingdao, Shandong, China, 266000
        • Qingdao Central Hospital
      • Yantai, Shandong, China, 264000
        • Yantai Yuhangding Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 201200
        • Shanghai Pudong Hospital
    • Shanxi
      • Changzhi, Shanxi, China, 046000
        • Changzhi People'S Hospital
      • Jinzhong, Shanxi, China, 030602
        • The First People's Hospital of Jinzhong
      • Taiyuan, Shanxi, China, 030001
        • First Hospital of Shanxi Medical University
    • Sichuan
      • Dazhou, Sichuan, China, 635199
        • Dazhu County People's Hospital
      • Zigong, Sichuan, China, 643000
        • Zigong First People's Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Zhejiang Provincial People's Hospital
      • Taizhou, Zhejiang, China, 318000
        • Taizhou Hospital of Zhejiang Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18 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)
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Drug: Alteplase
Alteplase 0.9mg/kg are being used.
Other Names:
  • rt-PA
Experimental: Tenecteplase 0.25mg/kg
Patients will receive intravenous Tenecteplase, 0.25mg/kg, maximum 25mg, administered as a bolus over 5~10 seconds
Drug: Tenecteplase
Tenecteplase 0.25mg/kg are being used.
Other Names:
  • TNK-tPA
Drug: Tenecteplase
Tenecteplase 0.4mg/kg are being used.
Other Names:
  • TNK-tPA
Experimental: Tenecteplase 0.4mg/kg
Patients will receive intravenous Tenecteplase, 0.4mg/kg, maximum 40mg, administered as a bolus over 5~10 seconds
Drug: Tenecteplase
Tenecteplase 0.25mg/kg are being used.
Other Names:
  • TNK-tPA
Drug: Tenecteplase
Tenecteplase 0.4mg/kg are being used.
Other Names:
  • TNK-tPA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale(mRS)
Time Frame: 90±7 days
Proportion of subjects with mRS scores of (0-1) at 90±7 days.(Comments:The minimum and maximum values are from 0 to 6,and higher scores mean a worse outcome.)
90±7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: 24±2 hours
NIHSS score at 24±2 hours.(Comments:The minimum and maximum values are from 0 to 40, and higher scores mean a worse outcome.)
24±2 hours
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: 7±2days or discharge
Proportion of subjects with ≥ 4 point reduction in NIHSS or reaching 0-1 at 7 ± 2 days or before discharge (whichever occurs first).(Comments:The minimum and maximum values are from 0 to 40, and higher scores mean a worse outcome.)
7±2days or discharge
Modified Rankin Scale(mRS)
Time Frame: 90±7 days
Proportion of subjects with mRS scores of (0-2) at 90±7 days.(Comments:The minimum and maximum values are from 0 to 6,and higher scores mean a worse outcome.)
90±7 days
Modified Rankin Scale(mRS)
Time Frame: 90±7 days
mRS scores at 90±7 days.(Comments:The minimum and maximum values are from 0 to 6,and higher scores mean a worse outcome.)
90±7 days
The new vascular events
Time Frame: 90±7 days
Incidence of the new vascular events, ischemic stroke, hemorrhagic stroke, myocardial infarction and cardio-cerebral revascularization at 90±7 days. (including: carotid endarterectomy, intracranial and extracranial artery interventional therapy, intracranial and extracranial artery bypass surgery, coronary interventional or bypass therapy)
90±7 days
Deaths
Time Frame: 90±7 days
Vascular mortality at 90±7 days (mainly due to stroke, myocardial infarction or pulmonary embolism)
90±7 days
EQ-5D
Time Frame: 90±7 days
EQ-5D scores at 90±7 days.(Comments:The minimum and maximum values are from 0 to 100,and higher scores mean a better outcome.)
90±7 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Symptomatic intracranial hemorrhage(sICH)
Time Frame: 24~30 hours post treatment
Incidence of symptomatic intracranial hemorrhage (sICH) within 24~30 hours.( According to ECASSII)
24~30 hours post treatment
Parenchymal hematoma type 2(PH2) intracranial hemorrhage
Time Frame: 24~30 hours post treatment
Incidence of intracranial hemorrhage (PH2) within 24~30 hours.
24~30 hours post treatment
Any intracranial hemorrhage
Time Frame: 24~30 hours post treatment
Incidence of any intracranial hemorrhage within 24~30 hours.
24~30 hours post treatment
Systematic bleeding
Time Frame: 30 hours
Incidence of Systematic bleeding within 30 hours. ( defined by PLATO)
30 hours
Deaths
Time Frame: 90±7 days
Mortality due to any cause at 90±7days.
90±7 days
AEs/SAEs
Time Frame: 90±7 days
Incidence of adverse events(AEs) / severe adverse events(SAEs) at 90±7 days.
90±7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tiantan Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jiangsu FENG HUA Biotech Pharmaceutical Co., Ltd
The Place Pharmaceutical(Jiangsu) Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Shuya Li, IRB of Beijing Tiantan Hospital,Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 28, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PR-SMTJ-2019001F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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