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

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.