A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity

Last updated: December 6, 2024
Sponsor: Boehringer Ingelheim
Overall Status: Completed

Phase

3

Condition

Stroke

Cerebral Ischemia

Treatment

alteplase

tenecteplase

Clinical Study ID

NCT04915729
1123-0040
  • Ages > 18
  • All Genders

Study Summary

This study is open to Chinese adults who had an ischaemic stroke, which means that blood vessels in the brain are blocked. To resolve blood clots, people in the study get either tenecteplase or alteplase within 4 hours and 30 minutes after stroke. The purpose of this study is to compare how tenecteplase and alteplase improve peoples' recovering of physical activity. Alteplase is standard of care. Tenecteplase is a modified variant of alteplase that is easier to administer and is approved to treat heart attack. This study is to find out whether tenecteplase is as good as alteplase in people with ischaemic stroke.

Participants are equally put into 2 treatment groups by chance. Participants in one group get tenecteplase as a single injection into a vein. Participants in the other group get alteplase as an injection into a vein (10% of the dose) and the remainder as an infusion over 1 hour.

Participants are in the study for about 3 months. They are in the hospital for the first week after treatment. Then they visit the study site 1 and 3 months after treatment. At these visits, peoples' ability to independently carry out daily activities is assessed. Scores for physical activity are compared between both treatment groups. The doctors also regularly check the general health of the participants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years old

  • Diagnosis of ischaemic stroke with a measurable neurological deficit on NationalInstitutes of Health Stroke Scale (NIHSS) (0< NIHSS ≤25); if NIHSS <4, patients haveto be with at least a measurable deficit on motor power (upper or lower limbs ≥1)

  • Stroke symptoms should have been present for at least 30 minutes (min) withoutsignificant improvement prior to randomisation

  • Thrombolytic therapy can be initiated within 4.5 Hour(s) (h) of Acute ischaemicstroke (AIS) onset

  • Patients with premorbid modified Rankin Scale (mRS) 0 or 1

  • Signed and dated written informed consent in accordance with good clinical practice (GCP) and local legislation prior to trial admission

Exclusion

Exclusion Criteria:

  • Evidence of intracranial haemorrhage on the Computed tomography (CT) scan orsymptoms suggestive of subarachnoid haemorrhage, even if the CT scan is normal

  • Patients who must or are expected to continue the intake of restricted medicationsor any drug considered likely to interfere with the safe conduct of the trial

  • Acute bleeding diathesis, including but not limited to

  • Known genetic predisposition to bleeding or significant bleeding disorder atpresent or within the past 6 Month(s) (m)

  • Administration of heparin within the previous 48 h and activated partialthromboplastin time (aPTT) exceeding the upper limit of normal for laboratorymeasurement

  • Current use of vitamin K based oral anticoagulants (e.g. warfarin) and aprolonged prothrombin time (International normalised Ratio (INR) > 1.7 orProthrombin time (PT)>15 seconds (s)) or current use of novel oralanticoagulants (i.e. dabigitran, rivaroxiban, or apixiban) with prolongation ofactivated partial thromboplastin time (aPTT) and/or PT above the upper limit ofthe local laboratory reference range

  • Platelet count of below 100,000/mm3 at screening

  • Any history of central nervous system damage (i.e. neoplasm, aneurysm,intracranial or spinal surgery)

  • Recent traumatic external heart massage, obstetrical delivery, or recentpuncture of a non-compressive blood-vessel (e.g. subclavian or jugular veinpuncture) , within the past 10 days

  • Known history of suspected intracranial haemorrhage or suspected subarachnoidhaemorrhage from aneurysm

  • Neoplasm with increased haemorrhagic risk

  • Documented ulcerative gastrointestinal disease during the last 3 m, oesophagealvarices, arterial aneurysm, or arterial/venous malformations

  • Any known disorder associated with a significant increased risk of bleeding

  • Bacterial endocarditis or pericarditis at screening

  • Acute pancreatitis at screening

  • Significant trauma or major surgery (according to the investigator's assessment) inthe past 3 m

  • Imaging demonstrates multi-lobar infarction (hypodensity >1/3 cerebral hemisphere)

  • Severe uncontrolled arterial hypertension, e.g. systolic blood pressure (BP) >185mmHg or diastolic BP >110 mmHg Further exclusion criteria apply.

Study Design

Total Participants: 1489
Treatment Group(s): 2
Primary Treatment: alteplase
Phase: 3
Study Start date:
June 22, 2021
Estimated Completion Date:
October 08, 2023

Connect with a study center

  • Inner Mongolia Baogang Hospital

    Baotou, 14000
    China

    Site Not Available

  • Beijing Chao-Yang Hospital

    Beijing, 100020
    China

    Site Not Available

  • Beijing Tiantan Hospital affiliated to Cap Med University

    Beijing, 100070
    China

    Site Not Available

  • Beijing Tongren Hospital

    Beijing, 100730
    China

    Site Not Available

  • Beijing Tsinghua Changgung Hospital

    Beijing, 100044
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, 130031
    China

    Site Not Available

  • The third xiangya hospital of Central South University

    Changsha, 410013
    China

    Site Not Available

  • West China Hospital

    Chengdu, 610041
    China

    Site Not Available

  • Hexigten Banner Mongolian Traditional Chinese medicine hospital

    Chifeng, 025350
    China

    Site Not Available

  • Second Affiliated Hospital Chongqing Medical University

    Chongqing, 400016
    China

    Site Not Available

  • Center Hospital of Dalian

    Dalian, 116021
    China

    Site Not Available

  • Daqing People's Hospital

    Daqing, 163000
    China

    Site Not Available

  • Shengli Oilfield central hospital

    Dongying, 257091
    China

    Site Not Available

  • Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510150
    China

    Site Not Available

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, 550004
    China

    Site Not Available

  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

    Hangzhou, 310016
    China

    Site Not Available

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou, 310015
    China

    Site Not Available

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, 310009
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University

    Hangzhou, 210011
    China

    Site Not Available

  • Zhejiang Province People's Hospital

    Hangzhou, 310014
    China

    Site Not Available

  • Huai'an Second People's Hospital

    Huai'an, 223002
    China

    Site Not Available

  • The First Affiliated Hospital of Baotou Medical College

    Inner Mongolia, 014010
    China

    Site Not Available

  • The second Hospital of Jiaxing

    Jiaxing, 314001
    China

    Site Not Available

  • Center Hospital of Jinan

    Jinan, 250013
    China

    Site Not Available

  • Jinhua Municipal Central Hospital

    Jinhua, 321000
    China

    Site Not Available

  • The first People's Hospital of Lianyungang

    Lianyungang, 222002
    China

    Site Not Available

  • Linfen Central Hospital

    Linfen, 041000
    China

    Site Not Available

  • Taizhou Hospital of Zhejiang Province

    Linhai, 317000
    China

    Site Not Available

  • Linyi People's Hospital

    Linyi, 276000
    China

    Site Not Available

  • The First People's Hospital of Tancheng County

    Linyi, 276000
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, 210011
    China

    Site Not Available

  • Zhongda Hospital Southeast University

    Nanjing, 210009
    China

    Site Not Available

  • The First People's Hospital of Nanning

    Nanning, 530000
    China

    Site Not Available

  • The First People's Hospital of Nantong

    Nantong, 226001
    China

    Site Not Available

  • Ruian People's Hospital

    Ruian, 325200
    China

    Site Not Available

  • Shanghai East Hospital

    Shanghai, 200120
    China

    Site Not Available

  • Shanghai East Hospital, Tongji University China

    Shanghai, 200120
    China

    Active - Recruiting

  • Shanghai Seventh People's Hospital

    Shanghai, 200137
    China

    Site Not Available

  • Tongji Hospital, Tongji University

    Shanghai, 200065
    China

    Site Not Available

  • Tongren hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200051
    China

    Site Not Available

  • Affiliated Central Hospital of Shenyang Medical College

    Shenyang, 110000
    China

    Site Not Available

  • The First People's Hospital of Shenyang

    Shenyang, 110000
    China

    Site Not Available

  • Peking University Shenzhen Hospital

    Shenzhen, 518000
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, 050000
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215006
    China

    Site Not Available

  • The Second Affiliated Hospital of Soochow University

    Suzhou City, 215004
    China

    Site Not Available

  • Taizhou Hospital of Zhejiang Province

    Taizhou, 317099
    China

    Site Not Available

  • The 2nd Hospital of Tianjin Medical University

    Tianjin, 300000
    China

    Site Not Available

  • The First Center Hospital of Tianjin

    Tianjin, 300192
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, 30052
    China

    Site Not Available

  • Wuhan Union Hospital

    Wuhan, 430022
    China

    Site Not Available

  • Wuxi People's Hospital

    Wuxi, 214043
    China

    Site Not Available

  • Xianyang Hospital of Yan'an University

    Xianyang, 712000
    China

    Site Not Available

  • Xinxiang Central Hospital

    Xinxiang, 453000
    China

    Site Not Available

  • The People's Hospital Of Xuancheng City

    Xuancheng, 242000
    China

    Site Not Available

  • Affiliated Hospital, Xuzhou Medical college

    Xuzhou, 221006
    China

    Site Not Available

  • Affiliated Hospital of Yangzhou University

    Yangzhou, 225001
    China

    Site Not Available

  • Yantai Yuhuangding Hospital

    Yantai, 264010
    China

    Site Not Available

  • Yiyang Central Hospital

    Yiyang, 413000
    China

    Site Not Available

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