Acute ischemic stroke MedDRA version: 22.1 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 10029205 - Nervous system disorders MedDRA version: 22.1 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Metalyse
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: TENECTEPLASE
CAS Number: 191588-94-0
Concentration unit: U unit(s)
Concentration type: ran
Sponsors
Fakultní nemocnice u sv. Anny
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Clinical diagnosis of ischemic stroke (iCMP) with sudden and clear neurological deficit. • Onset of iCMP symptoms within the last 4.5 hours, with the exception of acute basilar artery occlusion, where IVT administration is accepted even after 4.5 hours from the onset of symptoms. • Age =18 years. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250
Exclusion criteria
Exclusion criteria: • Known hypersensitivity to the drug or to any of the excipients. • Demonstration of intracranial haemorrhage on CT or MR. • Demonstration of a brain disease other than ischemia as a cause of acute neurological deficit. • Presence of clear hypodense changes corresponding to acute cerebral ischemia in more than 1/3 of the cerebral media artery basin (ACM) on CT of the brain. • Suspected subarachnoid haemorrhage or clinical signs suggestive of subarachnoid haemorrhage, even if a negative CT scan is performed. • Acute internal bleeding. • Uncontrollable systolic blood pressure above 185 mm Hg or diastolic blood pressure above 110 mm Hg. Uncontrollable BP is considered to be a condition in which, despite adequate antihypertensive treatment, it is not possible to maintain BP values 1.7. It also applies to patients taking coumarin anticoagulants. Patients taking warfarin do not have an increased risk of symptomatic intracranial haemorrhage if the INR is below 1.7. Warfarin use is an absolute contraindication to IVT if the INR is above 1.7. • Platelet count below 100,000/µl; in patients without known thrombocytopenia, it is possible to initiate IVT without knowing the platelet count if their determination and evaluation would lead to a delay in the initiation of IVT; if a platelet count is found below 100,000/µl, IVT must be stopped immediately. • Heparin or low molecular weight heparin (LMWH) therapy in the last 48 hours and with an increased aPTT above the upper limit of the laboratory. • Abnormal specific coagulation tests with apaxiban, rivaroxaban and endoxaban. Abnormal coagulation tests are prolonged thrombin time (TT) or increased value of a specific anti-Xa test according to the laboratory standard • Parallel participation in any other trial involving investigational medication or medical devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main hypothesis of this clinical trial is that tenecteplase is non-inferior to alteplase in efficacy in patients with acute ischemic stroke eligible for i.v. thrombolysis as per current guidelines.;Secondary Objective: not applicable;Primary end point(s): 1) Non-inferiority of tenecteplase in efficacy terms, i.e. in the degree of functional independence at 90-120 days after stroke • Modified Rankin scale (mRS) – comparison of the proportion of patients with mRS 0-1 during 90-120 days after stroke in both study arms ;Timepoint(s) of evaluation of this end point: 90-120 days after stroke in both study arms | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Discharge destination (home, early supported discharge, rehabilitation facility, long term care, death) 2) Home time (defined as number of days subject spends at home after index stroke event) 3) Actual mRS score 90-120 day 4) Door to needle (DTN) time 5) Door-in-door-out (DIDO) times at Primary Stroke Centers 6) Recanalization status (mTICI score) at first angiographic acquisition in patients taken to the angio-suite for the purpose of administering endovascular thrombectomy (EVT) 7) Proportion of patients administered EVT 8) Door-to-groin puncture time in patients undergoing EVT 9) CT-to-puncture time in patients undergoing EVT 10) Return to baseline level of functioning;Timepoint(s) of evaluation of this end point: hospitalisation phase;90-120 days after stroke in both study arms | — |
Countries
Czech Republic
Contacts
Public ContactFarmakologický ústav
Masarykova univerzita - Lékarská fakulta
Outcome results
None listed