Overview

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

Status:
Withdrawn
Trial end date:
2018-09-01
Target enrollment:
0
Participant gender:
All
Summary
Proximal Middle Cerebral Artery (MCA) occlusions constitute the most severe stroke. Intra-venous thrombolysis with rt-PA within the first 4,5 hours is the only proven effective treatment. Prognosis is closely related to the recanalization rate that reaches only 30 to 50%. A new therapeutic strategy consisting in a sequential intravenous (IV) thrombolysis by rt-PA followed by 50UI/kg of IV tenecteplase (TNK) has been proposed in case of no recanalization after rt-PA. A case series of 13 consecutive patients treated by this association has been published in 2011. A high rate of recanalization without hemorrhagic transformation increase has been reported. However, efficiency and safety of this therapeutic have to be assessed in a randomized multi-centric study. Such a study is of great interest since interventional neuroradiology has not already shown superiority regarding IV rt-PA. Moreover interventional neuroradiologists specialists are only available in major hospital and an IV sequential strategy could provide an interesting alternative. Main study objectives: Main Clinical Objective: Sequential thrombolysis should be associated with a significant better outcome at 3-month, assessed by the modified Rankin score (mRS). Main Radiological Objective: Sequential thrombolysis should be associated with a higher rate of recanalization (TIMI 2b/3) at 24-hour.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital Center of Martinique
Treatments:
Tenecteplase
Tissue Plasminogen Activator
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 scoreā‰„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