A Phase 2 interventional study of TNK-tPA in Acute Ischemic Stroke, sponsored by Beijing Tiantan Hospital. Completed at 24 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-21.
Sponsored by Beijing Tiantan Hospital · Phase 2, Interventional, and Treatment
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.
To evaluate the safety and efficacy of rhTNK-tPA at different doses of 0.10 mg/kg, 0.25 mg/kg and 0.32 mg/kg compared with standard rt-PA intravenous thrombolytic therapy within 3 hours after onset of ischemic stroke. The primary objective of this study is to evaluate the differences of NIHSS scores among the four treatment groups at 14 days after intravenous thrombolysis.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 240 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 )
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.
Dissolve one vial of rhTNK-tPA in 3 ml sterile water for injection to prepare a solution of 5.33 mg/ml. Calculate the required volume according to the body weight of the subject, then measure the required volume. Administer as a single 0.10 mg/kg IV bolus over 5-10 seconds.
Drug: TNK-tPA
Dissolve one vial of rhTNK-tPA in 3 ml sterile water for injection to prepare a solution of 5.33 mg/ml. Calculate the required volume according to the body weight of the subject, then measure the required volume. Administer as a single 0.25 mg/kg IV bolus over 5-10 seconds.
Drug: TNK-tPA
Dissolve one vial of rhTNK-tPA in 3 ml sterile water for injection to prepare a solution of 5.33 mg/ml. Calculate the required volume according to the body weight of the subject, then measure the required volume. Administer as a single 0.32 mg/kg IV bolus over 5-10 seconds.
Drug: TNK-tPA
10% of rt-PA 0.9 mg/kg administered as an initial IV bolus followed by the remaining 90% as an IV infusion over the next 1 hour.
Drug: TNK-tPA
Experimental arms for low, middle, and high dosing; and active control arm for the standard protocol
Also known as: rtPA
National Institutes of Health Stroke Scale (NIHSS)
Proportion of subjects with NIHSS 1 or at least 4 on the NIHSS score decreased from the baseline at day14.
Time frame: 14 days
Modified Rankin Scale (mRS)
1. Proportion of subjects of excellent outcome defined as mRS (0-1) at 90 days. 2. Ordinal distribution of mRS and change of proportion of subjects with mRS (0-2) at 90 days.
Time frame: 90 days
National Institutes of Health Stroke Scale (NIHSS)
Neurological impairment defined as change of NIHSS score at 90 days.
Time frame: 90 days
Barthel(BI)
Global function of daily living defined as BI ≥ 95 at 90 days.
Time frame: 90 days
EQ-5D
Quality of life measured by EQ-5D scale.
Time frame: 90 days
Symptomatic intracranial hemorrhage(sICH)
Proportion of subjects with symptomatic intracranial hemorrhage (sICH) at 36 hours.
Time frame: 36 hours
Death
Overall mortality rate at 90 days.
Time frame: 90 days
Asymptomatic intracranial hemorrhage
Proportion of patients with asymptomatic intracranial hemorrhage at 90 days.
Time frame: 90 days
Hemorrhage in other parts
The proportion of patients with other bleeding events was defined by GUSTO bleeding at 90 days.
Time frame: 90 days
AE/SAE
Proportion of patients with adverse events / severe adverse events at 90 days.
Time frame: 90 days
Plan to share: No
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Beijing Tiantan Hospital