Status:
COMPLETED
A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 altepl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2023
Estimated Enrollment :
1489 Patients enrolled
Trial Details
Trial ID
NCT04915729
Start Date
June 22 2021
End Date
October 8 2023
Last Update
December 10 2024
Active Locations (55)
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1
Inner Mongolia Baogang Hospital
Baotou, China, 14000
2
Beijing Chao-Yang Hospital
Beijing, China, 100020
3
Beijing Tsinghua Changgung Hospital
Beijing, China, 100044
4
Beijing Tiantan Hospital affiliated to Cap Med University
Beijing, China, 100070