Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT02338466
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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02338466
Study Brief:
Protocol Section:
NCT02338466