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

Stroke Clinical Trial

— ORIGINAL  

Official title:

A Phase III Multi-centre, Prospective, Randomised, Open Label, Blinded Endpoint (PROBE), Active-controlled Parallel Group Trial to Assess Efficacy and Safety of Tenecteplase Versus Alteplase in Chinese Patients With Acute Ischaemic Stroke Within 4.5 Hours After Stroke Onset

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04915729
• Other study ID #: 1123-0040
• Status: Completed
• Phase: Phase 3
• Start date: June 22, 2021
• Est. completion date: October 8, 2023

Study information

• Verified date: December 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1490
• Est. completion date: October 8, 2023
• Est. primary completion date: October 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years old
• Diagnosis of ischaemic stroke with a measurable neurological deficit on National Institutes of Health Stroke Scale (NIHSS) (0< NIHSS =25); if NIHSS <4, patients have to 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) without significant improvement prior to randomisation
• Thrombolytic therapy can be initiated within 4.5 Hour(s) (h) of Acute ischaemic stroke (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 Criteria:

• Evidence of intracranial haemorrhage on the Computed tomography (CT) scan or symptoms suggestive of subarachnoid haemorrhage, even if the CT scan is normal
• Patients who must or are expected to continue the intake of restricted medications or 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 at present or within the past 6 Month(s) (m)
• Administration of heparin within the previous 48 h and activated partial thromboplastin time (aPTT) exceeding the upper limit of normal for laboratory measurement
• Current use of vitamin K based oral anticoagulants (e.g. warfarin) and a prolonged prothrombin time (International normalised Ratio (INR) > 1.7 or Prothrombin time (PT)>15 seconds (s)) or current use of novel oral anticoagulants (i.e. dabigitran, rivaroxiban, or apixiban) with prolongation of activated partial thromboplastin time (aPTT) and/or PT above the upper limit of the 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 recent puncture of a non-compressive blood-vessel (e.g. subclavian or jugular vein puncture) , within the past 10 days
• Known history of suspected intracranial haemorrhage or suspected subarachnoid haemorrhage from aneurysm
• Neoplasm with increased haemorrhagic risk
• Documented ulcerative gastrointestinal disease during the last 3 m, oesophageal varices, 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) in the past 3 m
• Imaging demonstrates multi-lobar infarction (hypodensity >1/3 cerebral hemisphere)
• Severe uncontrolled arterial hypertension, e.g. systolic blood pressure (BP) >185 mmHg or diastolic BP >110 mmHg Further exclusion criteria apply.

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• tenecteplase
tenecteplase
• alteplase
alteplase

Locations

Country	Name	City	State
China	Inner Mongolia Baogang Hospital	Baotou
China	Beijing Chao-Yang Hospital	Beijing
China	Beijing Tiantan Hospital affiliated to Cap Med University	Beijing
China	Beijing Tongren Hospital	Beijing
China	Beijing Tsinghua Changgung Hospital	Beijing
China	The First Hospital of Jilin University	Changchun
China	The third xiangya hospital of Central South University	Changsha
China	Hexigten Banner Mongolian Traditional Chinese medicine hospital	Chifeng
China	Second Affiliated Hospital Chongqing Medical University	Chongqing
China	Center Hospital of Dalian	Dalian
China	Daqing People's Hospital	Daqing
China	Shengli Oilfield central hospital	Dongying
China	Third Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	The Affiliated Hospital of Guizhou Medical University	Guiyang
China	Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine	Hangzhou
China	The Affiliated Hospital of Hangzhou Normal University	Hangzhou
China	The Second Affiliated Hospital of Nanjing Medical University	Hangzhou
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou
China	Zhejiang Province People's Hospital	Hangzhou
China	Huai'an Second People's Hospital	Huai'an
China	The First Affiliated Hospital of Baotou Medical College	Inner Mongolia
China	The second Hospital of Jiaxing	Jiaxing
China	Center Hospital of Jinan	Jinan
China	Jinhua Municipal Central Hospital	Jinhua
China	The first People's Hospital of Lianyungang	Lianyungang
China	Linfen Central Hospital	Linfen
China	Taizhou Hospital of Zhejiang Province	Linhai
China	Linyi People's Hospital	Linyi
China	The First People's Hospital of Tancheng County	Linyi
China	The First Affiliated Hospital of Nanchang University	Nanchang
China	Zhongda Hospital Southeast University	Nanjing
China	The First People's Hospital of Nanning	Nanning
China	The First People's Hospital of Nantong	Nantong
China	Ruian People's Hospital	Ruian
China	Shanghai East Hospital	Shanghai
China	Shanghai Seventh People's Hospital	Shanghai
China	Tongji Hospital, Tongji University	Shanghai
China	Tongren hospital, Shanghai Jiaotong University School of Medicine	Shanghai
China	Affiliated Central Hospital of Shenyang Medical College	Shenyang
China	The First People's Hospital of Shenyang	Shenyang
China	Peking University Shenzhen Hospital	Shenzhen
China	The Second Hospital of Hebei Medical University	Shijiazhuang
China	The Second Affiliated Hospital of Soochow University	Suzhou City
China	The 2nd Hospital of Tianjin Medical University	Tianjin
China	The First Center Hospital of Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin
China	Wuhan Union Hospital	Wuhan
China	Wuxi People's Hospital	Wuxi
China	Xianyang Hospital of Yan'an University	Xianyang
China	Xinxiang Central Hospital	Xinxiang
China	The People's Hospital Of Xuancheng City	Xuancheng
China	Affiliated Hospital, Xuzhou Medical college	Xuzhou
China	Affiliated Hospital of Yangzhou University	Yangzhou
China	Yantai Yuhuangding Hospital	Yantai
China	Yiyang Central Hospital	Yiyang

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale (mRS) score of 0 or 1	Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death).	up to 90 days
Secondary	Major neurological improvement (National Institutes of Health Stroke Scale (NIHSS) score of 0 or improvement of at least 4 points compared with baseline)	National Institutes of Health Stroke Scale (NIHSS) is a 11-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 6 grades with 0 as normal, and there is an allowance for untestable items.	up to 24 hours
Secondary	Modified Rankin Scale (mRS) score of 0-2		up to 90 days
Secondary	Change from baseline of National Institutes of Health Stroke Scale (NIHSS) score		up to 90 days
Secondary	Distribution of Modified Rankin Scale (mRS)		up to 90 days
Secondary	Barthel Index score =95	The Barthel Index is an ordinal scale used to measure performance in activities of daily living (ADL). The Barthel Index consists of 10 items. The total score of the Barthel Index ranges from 0 to 100, and higher scores indicate better outcome.	up to 90 days
Secondary	Symptomatic Intracerebral Haemorrhage (sICH) per European Cooperative Acute Stroke Study (ECASS) ? definition during on-treatment period		up to 36 hours
Secondary	90-day mortality		up to 90 days
Secondary	Modified Rankin Scale (mRS) score of 5 or 6		up to 90 days

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