|- candidate number||21727|
|- NTR Number||NTR5073|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-feb-2015|
|- Secondary IDs||Dossiernumber ZonMW 837004005 |
|- Public Title||Cost-effectiveness analyses and LOng Term follow-up in patients randomised in a Multicenter Randomized CLinical trial of Endovascular treatment for Acute ischemic stroke in The Netherlands |
|- Scientific Title||Cost-effectiveness analyses and LOng Term follow-up in patients randomised in a Multicenter Randomized CLinical trial of Endovascular treatment for Acute ischemic stroke in The Netherlands |
|- ACRONYM||CLOT-MR CLEAN|
|- Healt Condition(s) or Problem(s) studied||Endovascular revascularization, Acute ischaemic stroke, Cost-effectiveness |
|- Inclusion criteria||INCLUSION CRITERIA|
• A clinical diagnosis of acute stroke, with a deficit on the NIH stroke scale of 2 points or more.
• CT or MRI scan ruling out intracranial hemorrhage.
• Intracranial arterial occlusion of the distal intracranial carotid artery or middle (M1/M2) or anterior (A1/A2) cerebral artery, demonstrated with CTA, MRA, DSA or transcranial Doppler/duplex (TCD).
• The possibility to start treatment within 6 hours from onset.
• Informed consent given.
• Age 18 or over.
|- Exclusion criteria||GENERAL EXCLUSION CRITERIA|
• Arterial blood pressure > 185/110 mmHg.
• Blood glucose < 2.7 or > 22.2 mmol/L.
• Intravenous treatment with thrombolytic therapy in a dose exceeding 0.9 mg/kg alteplase or 90 mg.
• Intravenous treatment with thrombolytic therapy despite contra-indications, i.e. major surgery, gastrointestinal bleeding or urinary tract bleeding within the previous 2 weeks, or arterial puncture at a non-compressible site within the previous 7 days.
SPECIFIC EXCLUSION CRITERIA FOR INTENDED MECHANICAL THROMBECTOMY
• Laboratory evidence of coagulation abnormalities, i.e. platelet count <40 x 109/L, APTT>50 sec or INR >3.0.
SPECIFIC EXCLUSION CRITERIA FOR INTENDED INTRA-ARTERIAL THROMBOLYSIS
• Cerebral infarction in the distribution of the relevant occluded artery in the previous 6 weeks.
• History of intracerebral hemorrhage.
• Severe head injury (contusion) in the previous 4 weeks.
• Clinical or laboratory evidence of coagulation abnormalities, i.e. platelet count <90 x 109/L, APTT>50
sec or INR >1.7. Current treatment with oral thrombin antagonists, such as argatroban and dabigatran or treatment with oral selective Factor Xa inhibitors, such as rivaroxaban.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2010|
|- planned closingdate||1-jul-2017|
|- Target number of participants||500|
|- Interventions||endovascular treatment consist of arterial catheterization with a microcatheter to the level of occlusion and delivery of a thrombolytic agent and/ or mechanical thrombectomy.
Both alteplase and urokinase for intra-arterial thrombolysis is allowed into the trial, a dose of 1 mg alteplase is considered to be equivalent to 10.000-15.000 U urokinase.44
Mechanical treatment may consist of mechanical thrombectomy, aspiration, or stenting. Specific recommendations with regards to procedures and devices will be issued regularly by the trial steering committee.
|- Primary outcome||1. modified Rankin scale and quality of life at 2 years after randomization|
2. costs per patient without poor outcome on the Modified Rankin Scale (mRs) and the costs per quality-adjusted life year (QALY) at 2 years after randomization
|- Secondary outcome||Our secondary objectives regarding the long term clinical outcome include occurrence of recurrent strokes and mortality in both treatment groups
|- Timepoints||3 months, 6 months, 1 year, 1,5 years and 2 years|
|- Trial web site||not available |
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. Y.B.W.E.M. Roos|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. Y.B.W.E.M. Roos|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||The current study describes a cost-effectiveness analysis on top of a large clinical trial investigating the effect of
endovascular treatment on overall functional outcome after acute ischemic stroke. This so-called MR CLEAN trial is funded by the Netherlands Heart Foundation and is including patients since 2010. It will generate data on
efficacy, safety and effectiveness of cerebral endovascular treatment, and will provide important information on logistics and implementation of endovascular treatment in the Netherlands. However, it is also mandatory to study the cost effectiveness of this new and expensive treatment modality and assess its health care budget impact before large scale implementation eventually starts. The MR CLEAN trial is an ideal setting for measuring the societal costs related to endovascular treatment after strok. The current study will measure all direct and indirect medical as well as direct non-medical costs of treating stroke patients in the trial, thereby enabling a full economic evaluation of cerebral endovascular treatment (against standard care) from a societal perspective with the costs per patient with poor outcome and the costs per quality-adjusted life year as the outcome parameters. The time horizon will be two years. Long-term consequences of endovascular treatment in patients with cerebral infarction beyond two years until the end of life will be addressed in a model-based analysis assuming different scenarios of natural courses of stroke. In addition, a budget impact analysis is proposed by combining the health care cost data with national incidence and prevalence estimates of stroke. The MR CLEAN trial itself will answer the question whether higher recanalization rates improve functional outcome and quality of life. The current proposal will investigate whether the treatment can be considered to be cost-effective and what the Dutch Health Care budget impact will be.|
|- Main changes (audit trail)|
|- RECORD||26-feb-2015 - 20-apr-2015|