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TerminatedNCT02016547TURANDOTUpdated Apr 25, 2014

Thrombectomy Under Reopro Versus Alteplase to Treat Stoke

A Phase 4 interventional study of abciximab IV and thrombectomy and alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip) in Infarction, Middle Cerebral Artery, sponsored by SOS Attaque Cérébrale. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-25.

Sponsored by SOS Attaque Cérébrale · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Infarction, Middle Cerebral Artery

Keywords

  • Stroke
  • Middle Cerebral Artery
  • Thrombectomy
  • Mechanical Thrombolysis
  • Abciximab
03

In context

Infarction, Middle Cerebral Artery

47 studies on the registry are indexed under Infarction, Middle Cerebral Artery; 6 are open to participants now.

This study's planned enrollment of 40 is below the median of 50 across 37 interventional studies indexed under Infarction, Middle Cerebral Artery.

Browse Infarction, Middle Cerebral Artery studies →

Lead sponsor

SOS Attaque Cérébrale is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    abciximab IV and thrombectomy

    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

  • Active comparator
    alteplase

    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

  • Procedureabciximab IV and thrombectomy
  • Drugalteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip)
06

What researchers measure

Primary outcomes

  1. recanalization rate

    Time frame: 24 hours

Secondary outcomes

  1. Symptomatic intracranial bleeding

    Time frame: 24 hours

  2. percentage of patients with a favorable outcome

    Time frame: 3 months

07

Study locations

1 site
  • Stroke Center, Bichat Hospital
    Paris, 78018, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02016547
Lead sponsor
SOS Attaque Cérébrale
Responsible party
Sponsor
First posted
Dec 20, 2013
Start date
Sep 2013
Primary completion
Feb 2015 (estimated)
Completion
Feb 2015 (estimated)
Last update
Apr 25, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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