Overview

Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events(TRACE)

Status:
Completed
Trial end date:
2020-07-10
Target enrollment:
0
Participant gender:
All
Summary
To explore the safe and efficacious dose of rhTNK-tPA injection administered within 3 hours after onset of hyperacute ischemic stroke; to provide dose evidence for phase III clinical trial.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beijing Tiantan Hospital
Collaborators:
Baotou Central Hospital
First Affiliated Hospital of Jinan University
First Hospital of Jilin University
Fudan University
Guangzhou Recomgen Biotech Co., Ltd.
Hebei Medical University Third Hospital
Huashan Hospital
Inner Mongolia Baogang Hospital
Linyi People's Hospital
The First Affiliated Hospital of Zhengzhou University
The First Hospital of Jilin University
The First Hospital Of Qiqihar
West China Hospital
Yantai Yuhuangding Hospital
Treatments:
Tenecteplase
Criteria
Inclusion Criteria:

1. Age over 18 years.

2. Time from onset to treatment < 3 hours; the time symptoms start is defined as "the
last moment they appear normal".

3. Diagnosis of ischemic stroke according to "2014 China Guideline for Diagnosis and
Treatment of Acute Ischemic Stroke" with assessable neurological impairment e.g.,
language, motor function, cognitive impairment, gaze impairment, visual field deficit
and/or visual neglect. Ischemic stroke is defined as sudden acute focal neurological
impairment with suspected cerebral ischemia, hemorrhage ruled out by CT scan.

4. mRS > 2 at the first onset or prior onset.

5. Baseline NIHSS score is > 4 and < 26.

6. Signed informed consent.

Exclusion Criteria:

1. Absolute contraindications:

1.1 History of severe head trauma or stroke within 3 months; 1.2 Suspected
subarachnoid hemorrhage; 1.3 Arterial puncture at a non-compressible site within the
previous 1week; 1.4 History of intracranial hemorrhage; 1.5 Intracranial tumor,
vascular malformation, or arterial aneurysm; 1.6 Recent intracranial or intraspinal
surgery; 1.7 Systolic blood pressure ≧ 180 mm Hg, or diastolic blood pressure ≧ 100 mm
Hg; Increased blood pressure; 1.8 Active internal bleeding ; 1.9 Acute bleeding
tendency, including platelet count below 100×109/L or otherwise; 1.10 Heparin
treatment was performed within 48 h ( APTT exceeded the upper limit of normal range )
; 1.11 Warfarin has been taken orally , and the international standardized ratio is
INR > 1.7 or PT > 15 s ; 1.12 Anticoagulant drugs such as thrombin inhibitor or Xa
factor inhibitor , argatroban ( including new anticoagulants with unclear mechanism )
are currently being used , and various sensitive laboratory tests are abnormal ( such
as live ) APTT , INR , Platelet count , Serpentine ECT of pulse enzyme setting time ;
thrombin time TT or appropriate determination of Xa factor activity ) ; 1.13 Blood
glucose < 2.7 mmol/L; 1.14 CT showed multilobular infarction ( low density > 1 / 3
cerebral hemisphere )

2. Relative contraindications : The risks and benefits of thrombolysis should be
carefully considered and weighed in the following cases ( that is , although there is
one or more relative contraindications , it is not absolutely impossible to
thrombolysis ).

2.1 Mild stroke or stroke with rapid improvement of symptoms; 2.2 Women in pregnancy ;
2.3 Symptoms of neurological impairment after seizures ; 2.4 There have been major
surgical operations or serious injuries in the last 2 weeks; 2.5 There were
gastrointestinal or urinary system bleeding in recent 3 weeks ; 2.6 History of
myocardial infarction within 3 months.

3. Have been enrolled in rhTNK-tPA in pre-study or participated in other clinical trials
within 3 months prior to screening.

4. Lactating women, or childbearing women who do not use effective contraception.

5. Known allergy to rhTNK-tPA and/or rt-PA or relevant excipients.

6. The researchers judged that not suitable to participate in this study or participate
in this study may lead to greater risk for patients ;

7. Can not comply with the test program or follow-up requirements .