Basilar artery occlusion. MedDRA version: 18.0 Level: PT Classification code 10063093 Term: Basilar artery thrombosis System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0 Level: PT Classification code 10048963 Term: Basilar artery occlusion System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Medacinase
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: UROKINASE
CAS Number: 9039-53-6
Current Sponsor code: none
Other descriptive name: UROKINASE
Concentr
Sponsors
BASICS Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Symptoms and signs compatiblewith ischemia in the basilar artery territory • Basilar artery occlusion confirmed by CTA or MRA • Age18 or older (i.e., candidates must have had their 18th birthday). • If IVT is considered as part of best medical treatment IV rt-PA needs to be initiated within 4.5 hours of estimated time of basilar artery occlusion. (Estimated time of basilar artery occlusion is defined as time of onset of acute symptoms leading to clinical diagnosis of basilar artery occlusion or if not known last time patient was seen normal prior to onset of these symptoms – this time is not necessarily the same as the time of onset of first symptoms). • Initiation of IA therapy should be feasible within 6 hours of estimated time of basilar artery occlusion. 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 375 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 375
Exclusion criteria
Exclusion criteria: •Pre-existing dependency with mRankin =3. •Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission. •Patients that require hemodialysis or peritoneal dialysis. •Other serious, advanced, or terminal illness. •Any other condition that the investigator feels would pose a significant hazard to the patient if thrombolytic therapy is initiated. •Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days). •Informed consent is not or can not be obtained. Imaging Exclusion Criteria: •Lesion consistent with hemorrhage of any degree. •Significant cerebellar mass effect or acute hydrocephalus •Bilateral extended brainstem ischemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of additional IA therapy in addition to best medical treatment in terms of favourable outcome at 90 days, defined as a modified Rankin score of 0-3, in patients with an acute ischemic stroke caused by basilar artery occlusion. Secondary analysis will compare outcome in the following pre-defined subgroups: - patients with a baseline NIHSS of 10 -19, and those with a baseline NIHSS of = 20. - patients treated with IVT within 4.5 hours of symptom onset, and those treated beyond 4.5 hours of symptom onset within 4.5 hours of estimated time of basilar artery occlusion. - patients treated with IVT and those with a contra-indication for IVT.;Secondary Objective: • To evaluate the efficacy of IAT in patients with a contra-indication for IVT in terms of favourable outcome at 90 days • To evaluate the safety of a combined IV/IA approach compared to IV rt-PA alone. The primary measures of safety will be symptomatic intracranial haemorrhage(ICH) or ICH contributing to patients death • To evaluate the efficacy of a combined IV/IA approach compared to IV rt-PA alone in terms of a favourable outcome at day 90 on other clinical and radiological maesures: 1) Excellent outcome defined as a mRS of 0-2, 2) mRS - not dichotomized, 3)NIHSS and EuroQol. 4) an improved early response to treatment as determined by a reduction in NIHSS by 5 points or more at 24 hours. 5) A CT or MR angiography assessment of basilar artery patency at 24 hours . 6) the volume of cerebral infarction as maesured by NCCT/CTA-SI at 24 hours. • To evaluate the safety and efficacy of mechanical devices as part of a combined IV/IA approach as the BASICS trial progresses. ;Primary end point(s): Favorable outcome at day 90 defined as a modified Rankin Score (mRS – functional scale) of 0-3.;Timepoint(s) of evaluation of this end point: Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 90 days -time of IVT, randomization, 24 hours post treatment -day 90 and at 12 months radiologic: -24 hours, ± 6 hours safety: -24 hours, ± 6 hours 90 days;Secondary end point(s): - Excellent outcome at day 90 defined as a modified Rankin Score (mRS – functional scale) of 0-2. - Modified Rankin Score - not dichotomized. - Institutes of Health Stroke Scale (NIHSS – acute assessment scale) at time of IVT, at time randomization, at 24 hours post treatment. - EuroQol (quality of life) at day 90 and at 12 months Radiologic outcomes: -Recanalization at 24 hours, ± 6 hours, by CT angiography. -Volume of cerebral infarction on NCCT + CTA-SI Safety outcomes: -Symptomatic intracranial hemorrhage at 24 hours CT imaging, ± 6 hours. -Mortality at 90 days. | — |
Countries
Brazil, Czech Republic, Germany, Italy, Netherlands, Norway, Switzerland, United Kingdom
Contacts
Public ContactW. Schonewille
St. Antonius Hospital
Outcome results
None listed