Basilar Artery International Cooperation Study Trial.|
|- candidate number||8697|
|- NTR Number||NTR2617|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-nov-2010|
|- Secondary IDs||NL33550.100.10 / 2010B151 ; CCMO / Netherlands Heart Foundation|
|- Public Title||Basilar Artery International Cooperation Study Trial.|
|- Scientific Title||Basilar Artery International Cooperation Study Trial.|
|- ACRONYM||BASICS Trial|
|- hypothesis||The null hypothesis for this study is that additional intra-arterial treatment after intravenous thrombolysis in patients with a acute basilar artery occlusion leads to similar distribution of functional outcomes as intravenous thrombolysis alone.|
|- Healt Condition(s) or Problem(s) studied||Stroke, Posterior circulation, Basilar artery occlusion|
|- Inclusion criteria||1. Symptoms and signs compatible with ischemia in the basilar artery territory and an NIHSS ≥ 10 at time of randomization;|
2. Basilar artery occlusion confirmed by CTA or MRA;
3. Age 18 through 85 years (i.e., candidates must have had their 18th birthday, but not had their 86th birthday);
4. Initiation of IV rt-PA 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);
5. Initiation of IA therapy should be feasible within 6 hours of estimated time of basilar artery occlusion.
|- Exclusion criteria||1. Pre-existing dependency with mRankin ≥3;|
2. Females of childbearing potential who are known to be pregnant and/or lactating or
who have positive pregnancy tests on admission;
3. Patients who require hemodialysis or peritoneal dialysis;
4. Other serious, advanced, or terminal illness;
5. Any other condition that the investigator feels would pose a significant hazard to the
patient if IA therapy is initiated;
6. Current participation in another research drug treatment protocol (patient cannot start
another experimental agent until after 90 days);
7. Informed consent is not or cannot be obtained.
Imaging Exclusion Criteria:
1. Lesion consistent with hemorrhage of any degree;
2. Significant cerebellar mass effect or acute hydrocephalus;
3. Bilateral extended brainstem ischemia.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||23-okt-2011|
|- planned closingdate||23-okt-2017|
|- Target number of participants||750|
|- Interventions||IV rt-PA:|
All patients are treated with a standard full dose of open-label IV rt-PA (0.9mg/kg; 90mg
maximum) if standard eligibility criteria are met. Patients treated with IVT within 4.5 hours
of symptom onset, and those who are treated beyond 4.5 hours of symptom onset but
within 4.5 hours of estimated time of basilar artery occlusion will be regarded as two prespecified
subgroups for secondary analysis. In patients treated beyond 4.5 hours of
symptom onset, informed consent needs to be obtained prior to initiation of IVT.
IA therapy has to be initiated within 6 hours of estimated time of basilar artery occlusion.
If an appropriate thrombus or residual stenosis is identified, the choice of IA strategy will
be made by the treating neurointerventionalist. IA treatment options available will be any
of the following devices or thrombolytics, depending on local approval and experience;
the Concentric Merci® thrombus-removal device, Penumbra, Solitaire, infusion of rt-PA
combined with an application of low-intensity ultrasound at the site of the occlusion via
the EKOS® Micro-Infusion Catheter, infusion of alteplase or urokinase via a standard
micro-catheter. If IA thrombolysis is the chosen strategy, a maximum of 22 mg of IA rt-PA
or 1.500.000 Units of Urokinase may be given. Stenting is allowed in the presence of a
high-grade vertebral artery stenosis or occlusion hampering adequate endovascular
access to the basilar artery and in case of a residual high-grade basilar artery stenosis.
The use of any other treatment strategy depends on local approval and experience, and
is only allowed after prior approval of the steering committee.
The IA approach is aimed at recanalization of the basilar artery. In order to ensure
optimal perfusion one posterior cerebral artery should be patent. In the presence of
residual occlusions of branches of the basilar artery after complete recanalization of the
basilar artery the use of additional thrombolytic therapy should be kept to a minimum due
to the limited potential gain.
Clinical improvement could be a reason not to initiate IA therapy despite the presence of
persistent basilar artery occlusion on conventional angiography. The initiation of IA
therapy after identification of an appropriate thrombus in the basilar artery or high grade
residual stenosis considered to have been the cause of occlusion on conventional
angiography will be left to the judgment of the treating physician.
|- Primary outcome||Favourable outcome at day 90 defined as a modified Rankin Score (mRS – functional scale) of 0-3.|
|- Secondary outcome||1. Excellent outcome at day 90 defined as a modified Rankin Score (mRS – functional scale) of 0-2;|
2. Modified Rankin Score – not dichotomized;
3. National Institutes of Health Stroke Scale (NIHSS – acute assessment scale) at time of IVT, at time randomization, at 48 hours post treatment;
4. EQ-5D (quality of life) at day 90 and at 12 months.
1. Recanalization at 24 hours, ± 6 hours, by CT angiography;
2. Volume of cerebral infarction on NCCT and CTA source images.
1. Symptomatic intracranial hemorrhage at 24 hours CT imaging, ± 6 hours;
2. Mortality at 90 days.
|- Trial web site||www.basicstrial.com|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| E.J.R.J. Hoeven, van der|
|- CONTACT for SCIENTIFIC QUERIES|| W.J. Schonewille|
|- Sponsor/Initiator ||Sint Antonius Ziekenhuis|
(Source(s) of Monetary or Material Support)
|Dutch Heart Foundation (Nederlandse Hartstichting), St Antonius Hospital, Nieuwegein|
|- Brief summary||Rationale:|
Recently our study group reported the results of the Basilar Artery International Cooperation Study (BASICS), a prospective registry of patients with an acute symptomatic basilar artery occlusion. Our observations in the BASICS registry underscore that we continue to lack a proven treatment modality for patients with an acute BAO and that current clinical practice varies widely. Furthermore, the often-held assumption that IAT is superior to IVT in patients with an acute symptomatic BAO is challenged by our data.
The BASICS registry was observational and has all the limitations of a non-randomised study. Interpretation of results is hampered by the lack of a standard treatment protocol for all patients who entered the study.
Evaluate the efficacy and safety of additional IA therapy after IV thrombolysis in patients with acute basilar artery occlusion.
Randomised, multi-centre, open label, controlled phase III, treatment trial.
Patients treated with IV thrombolysis and CTA or MRA confirmed basilar occlusion aged 18 through 85 years.
Patients will be randomised between additional IA therapy followed by maximum supportive care versus maximum supportive care alone.
IVT has to be initiated within 4.5 hours from estimated time of basilar artery occlusion and IA therapy within 6 hours.
Main study parameters/endpoints:
Favourable outcome at day 90 defined as a modified Rankin Score (mRS – functional scale) of 0-3.
Nature and extend of the burden and risks associated with participation, benifit and group relatedness:
Although, to date, no data from a randomised controlled trial support the use of IAT for BAO, IAT was by far the most commonly used treatment type in the BASICS registry. The use of additional IAT after standard IVT is supported by the results of trials performed with patients with occlusions in other vascular territories. Patients randomised into the additional IAT group will undergo intra-arterial catheterization and intra-arterial therapy will be initiated if indicated. Effective amount of radiation during this 1-2 hour procedure will be about 20 mSv. Main risks for catheterization and IAT comprise local and intracranial haemorrhage. In the BASICS registry we reported a risk for symptomatic intracranial haemorrhage of 14% in patients treated with IAT versus 6% in patients treated with IVT. Follow-up telephone surveys at 1 and 12 months and blinded exam at 3 months will take up to 50 minutes in total.
Recruiting countries: Australia, Brazil, Canada, Czech Republic, Germany, Israel, Italy, The Netherlands, Spain, Switserland, United Kingdom, United States.
|- Main changes (audit trail)||26-Apr-2012: Changes from amendment - NM|
Old exclusion criteria:
1. Pre-existing dependency with mRankin ≥3;
2. Previous intracranial hemorrhage due to neoplasm, subarachnoid hemorrhage, or arteriovenous malformation;
3. Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT scan is normal;
4. Hypertension at time of randomization; systolic BP > 185 or diastolic > 110 mm Hg; or aggressive measures to lower blood pressure to below these limits are needed;
5. Presumed septic embolus, or suspicion of bacterial endocarditis;
6. Presumed pericarditis including pericarditis after acute myocardial infarction;
7. Suspicion of aortic dissection;
8. Recent (within 30 days) surgery or biopsy of parenchymal organ;
9. Recent (within 30 days) trauma, with internal injuries or ulcerative wounds;
10. Recent (within 90 days) head trauma with loss of consciousness;
11. Any active or recent (within 30 days) hemorrhage;
12. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or oral anticoagulant therapy with INR > 1.7 or institutionally equivalent prothrombin time;
13. Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission;
14. Baseline lab values: glucose < 50 mg/dl or > 400 mg/dl, platelets <100,000, or Hct <25, INR >1,7;
15. Patients that require hemodialysis or peritoneal dialysis;
16. Patients who have received heparin within 48 hours must have a normal partial thromboplastin time (PTT) to be eligible;
17. Subjects with an arterial puncture at a non-compressible site or a lumbar puncture in the previous 7 days;
18. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations;
19. Other serious, advanced, or terminal illness;
20. Any other condition that the investigator feels would pose a significant hazard to the patient if thrombolytic therapy is initiated;
21. Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days);
22. Informed consent is not or cannot be obtained.
Imaging Exclusion Criteria:
1. High-density lesion consistent with hemorrhage of any degree;
2. Significant cerebellar mass effect or acute hydrocephalus;
3. Bilateral extended brainstem ischemia;
4. CT evidence of intraparenchymal tumor.
Old start- and enddate: 01-Jan-2011 and 01-Jan-2017.
|- RECORD||24-nov-2010 - 26-apr-2012|
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