Superiority of Rt-PA + Tenecteplase in Comparison With Rt-PA Only in Proximal Middle Cerebral Artery Occlusion

Launched by UNIVERSITY HOSPITAL CENTER OF MARTINIQUE · Jan 13, 2015

Keywords

ClinConnect Summary

This is a Phase 2, multi-center, national, randomized, biomedical study comparing two therapeutic strategies in ischemic stroke associated with proximal middle cerebral artery occlusion.

Patients will be included in two randomized arms and the new sequential treatment approach (rt-PA + tenecteplase) will be compared with the standard treatment (rt-PA alone).

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age between 18 and 85 years
• • Cerebral infarction in relation with a proximal middle cerebral artery occlusion (M1 ou M2)
• • NIHSS between 4 and 23
• • Patient treated with intravenous rt-PA (0,9 mg/kg) within the first 4.5 hours
• • No recanalization on the MRI performed 1 hour after rt-PA initiation (TIMI 0,1 ou 2a)
• • Administration of TNK within the first 6 hours
• • Informed and written consent obtained from the patient or next of kin
• • Patient insured under the French social security system
• Exclusion Criteria:
• • Contraindication to MRI
• • Contraindication to rt-PA administration
• • Contraindication to TNK administration
• • Contraindication to stroke thrombolysis
• • Refusal to sign the informed consent
• • Extensive small arteries disease (\>5 microbleed and/or Fazekas score≥3)
• • Systolic arterial pression\> 185 mmHg or diastolic arterial pression \> 110 mmHg
• • Glycemia \< 3 mmol/l (0,5g/l) or \> 22 mmol/l (4g/l)
• • Thrombopenia \< 100 000/mm3 or INR \> 1,5.
• • Patients treated with new oral anticoagulant.
• • Seizure as one of acute stroke symptoms
• • Lumbar or arterial puncture in the previous 7 days or major surgery in the previous 15 days
• • Carotid occlusion associated with MCA occlusion
• • Thrombus length \> 12mm assessed on gradient echo sequences
• • Large DWI lesion, defined as ASPECTS \< 7 / 10
• • DWI/PWI Mismatch \< 20% (when performed) on MRI 2
• • Marked FLAIR hypersignal on cortical structure and light hypersignal on caudate or lenticular nucleus assessed on MRI 2.
• • Parenchymal hemorrhage on MRI 2
• • Pregnancy or breast feeding
• • Patient currently included in a biomedical study