Thrombectomy Under Reopro Versus Alteplase to Treat Stoke

Infarction, Middle Cerebral Artery Clinical Trial

— TURANDOT  

Official title:

Thrombectomy Under Reopro Versus Alteplase and Neurologic Deficit Outcome Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02016547
• Other study ID #: 2012-005493-66
• Status: Terminated
• Phase: Phase 4
• First received: December 16, 2013
• Last updated: April 24, 2014
• Start date: September 2013
• Est. completion date: February 2015

Study information

• Verified date: April 2014
• Source: SOS Attaque Cérébrale
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthFrance: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction, Middle Cerebral Artery

Intervention

Procedure:
• abciximab IV and thrombectomy

Drug:
• alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip)

Locations

Country	Name	City	State
France	Stroke Center, Bichat Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
SOS Attaque Cérébrale

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recanalization rate		24 hours	No
Secondary	Symptomatic intracranial bleeding		24 hours	Yes
Secondary	percentage of patients with a favorable outcome		3 months	No