Thrombectomy Under Reopro Versus Alteplase to Treat Stoke

NCT02016547 | Terminated Phase 4 DMC

• 1 other identifier: 2012-005493-66
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infarction, Middle Cerebral Artery

Keywords

Stroke; Middle Cerebral Artery; Thrombectomy; Mechanical Thrombolysis; Abciximab

Outcome Measures

Primary Outcomes (1)

• recanalization rate

  24 hours

Secondary Outcomes (2)

• Symptomatic intracranial bleeding

  24 hours

• percentage of patients with a favorable outcome

  3 months

Study Arms (2)

abciximab IV and thrombectomy

EXPERIMENTAL

abciximab IV (0.25mg/kg by IV bolus, following by 0.125μg/kg by 12 hours IV drip) and thrombectomy

Procedure: abciximab IV and thrombectomy

alteplase

ACTIVE COMPARATOR

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

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

Interventions

abciximab IV and thrombectomy PROCEDURE

abciximab IV and thrombectomy

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

alteplase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \< 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SOS Attaque Cérébrale: lead

Study Sites (1)

Stroke Center, Bichat Hospital

Paris, 78018, France

Location

MeSH Terms

Conditions

Infarction, Middle Cerebral Artery; Stroke

Interventions

Thrombectomy; Tissue Plasminogen Activator; Infusions, Intravenous

Condition Hierarchy (Ancestors)

Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors; Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 20, 2013
• Study Start: September 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 25, 2014

Record last verified: 2014-04

Locations

FR (1)