Thrombectomy Under Reopro Versus Alteplase to Treat Stoke
Information source: SOS Attaque Cérébrale
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infarction, Middle Cerebral Artery
Intervention: abciximab IV and thrombectomy (Procedure); alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip) (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: SOS Attaque Cérébrale
Summary
Intravenous (IV) Alteplase (rt-PA) is the gold standard for brain infarction within 4 h 30
of symptoms onset. Efficacy of this therapy is limited in the setting of large artery
occlusions. For middle cerebral artery occlusions (MCA)or internal carotid artery occlusions
(ICA), recanalization rates will drop as low as 10%. This element is critical as prognosis
is linked to recanalization. Arterial re-occlusions are frequent and may reach 30%, which
limits IV thrombolysis efficacy. With the endovascular approach, recanalization rates may
reach 90% with last generation devices. A recent meta-analysis has shown that the best
candidates for thrombectomy are MCA occlusions. In the coronary literature, endovascular
therapy efficacy is increased in association with antiplatelets such as abciximab. The aim
of the study was to assess the feasibility of thrombectomy associated with abciximab on
revascularisation (TICI score), as well as safety (symptomatic intracranial bleeding), in
order to design a clinical trial versus the gold standard for acute ischemic stroke
revascularization strategies using IV rt-PA. This is a controlled, pilot study, evaluating
feasibility and safety of thrombectomy with abciximab versus IV rt-PA in acute ischemic
stroke patients within 4h30 of symptoms onset.
Clinical Details
Official title: Thrombectomy Under Reopro Versus Alteplase and Neurologic Deficit Outcome Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: recanalization rate
Secondary outcome: Symptomatic intracranial bleedingpercentage of patients with a favorable outcome
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical signs consistent with acute ischemic stroke < 4. 5 hours
- Cerebral infarction and middle cerebral artery occlusion, without any hemorrhage
documented by MRI or CT
- 4 < National Institute of Health Stroke Score (NIHSS) < 25
- age > 18 years
- no prestroke functional dependance : modified Rankin score ≤ 2
- subject or subject's legally authorized representative has signed and dated an
Informed Consent Form according to french regulations and ethic committee.
Exclusion Criteria:
- pregnant or lactating female
- coma (vigilance NIHSS > 1)
- epilepsy
- recent history of stroke
- anticoagulant therapy or International Normalized Ratio (INR) > 1. 7 ; heparin therapy
within past 24 hours and Temps de Cephaline Activee (TCA) extension
- previous subarachnoid hemorrhage or clinical presentation suggesting a subarachnoid
hemorrhage, even if initial CT or MRI scan are normal
- known hereditary or acquired hemorrhagics diathesis, coagulation factor deficiency
- uncontrolled hypertension defined as systolic blood pressure ≥ 185 millimeters of
mercury (mmHg) or diastolic blood pressure > 110 mmHg at time of admission and time
of threat
- lumbar ar arterial puncture within past 7 days
- major surgery within past 2 months
- gastrointestinal hemorrhage or urinary hemorrhage
- myocardial infarction within past 21 days
- pericarditis within past 3 months
- suspicion of bacterial endocarditis within past 3 months
- previous of aortic dissection
- baseline lab values : TCA > 40, platelets < 100 000/mm3, glucose < 3 mmol/l or > 22
mmol/l
- hepatic insufficiency
- CT or MRI evidence oh hemorrhage
- CT or MRI evidence of mass effect or intra-cranial tumor
- CT showing hypodensity or MRI showing hyperdensity involving greater than 1/3 of the
middle cerebral artery territory (ASPECT score < 7)
Locations and Contacts
Stroke Center, Bichat Hospital, Paris 78018, France
Additional Information
Starting date: September 2013
Last updated: April 24, 2014
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