Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-26 @ 8:10 AM
Study NCT ID:
NCT02338466
Status:
WITHDRAWN
Last Update Posted:
2018-06-21
First Post:
2015-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Superiority of Rt-PA + Tenecteplase in Comparison With Rt-PA Only in Proximal Middle Cerebral Artery Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}, {'id': 'D000077785', 'term': 'Tenecteplase'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Departure of the principal investigator and lack of succession', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-19', 'studyFirstSubmitDate': '2015-01-12', 'studyFirstSubmitQcDate': '2015-01-13', 'lastUpdatePostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical outcome ill be assessed at 3-month with the modified Rankin score by a blinded examiner.', 'timeFrame': '3 months', 'description': 'The clinical outcome will be assessed at 3-month with the modified Rankin score by a blinded examiner.\n\nA score of 0-2 is considered good prognosis and a score 3-6 define a poor prognosis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Nervous System Disorders', 'Cerebral Artery']}, 'descriptionModule': {'briefSummary': '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.\n\nMain study objectives:\n\nMain Clinical Objective:\n\nSequential thrombolysis should be associated with a significant better outcome at 3-month, assessed by the modified Rankin score (mRS).\n\nMain Radiological Objective:\n\nSequential thrombolysis should be associated with a higher rate of recanalization (TIMI 2b/3) at 24-hour.', 'detailedDescription': '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.\n\nPatients 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 85 years\n* Cerebral infarction in relation with a proximal middle cerebral artery occlusion (M1 ou M2)\n* NIHSS between 4 and 23\n* Patient treated with intravenous rt-PA (0,9 mg/kg) within the first 4.5 hours\n* No recanalization on the MRI performed 1 hour after rt-PA initiation (TIMI 0,1 ou 2a)\n* Administration of TNK within the first 6 hours\n* Informed and written consent obtained from the patient or next of kin\n* Patient insured under the French social security system\n\nExclusion Criteria:\n\n* Contraindication to MRI\n* Contraindication to rt-PA administration\n* Contraindication to TNK administration\n* Contraindication to stroke thrombolysis\n* Refusal to sign the informed consent\n* Extensive small arteries disease (\\>5 microbleed and/or Fazekas scoreā„3)\n* Systolic arterial pression\\> 185 mmHg or diastolic arterial pression \\> 110 mmHg\n* Glycemia \\< 3 mmol/l (0,5g/l) or \\> 22 mmol/l (4g/l)\n* Thrombopenia \\< 100 000/mm3 or INR \\> 1,5.\n* Patients treated with new oral anticoagulant.\n* Seizure as one of acute stroke symptoms\n* Lumbar or arterial puncture in the previous 7 days or major surgery in the previous 15 days\n* Carotid occlusion associated with MCA occlusion\n* Thrombus length \\> 12mm assessed on gradient echo sequences\n* Large DWI lesion, defined as ASPECTS \\< 7 / 10\n* DWI/PWI Mismatch \\< 20% (when performed) on MRI 2\n* Marked FLAIR hypersignal on cortical structure and light hypersignal on caudate or lenticular nucleus assessed on MRI 2.\n* Parenchymal hemorrhage on MRI 2\n* Pregnancy or breast feeding\n* Patient currently included in a biomedical study'}, 'identificationModule': {'nctId': 'NCT02338466', 'acronym': 'DIVA', 'briefTitle': 'Superiority of Rt-PA + Tenecteplase in Comparison With Rt-PA Only in Proximal Middle Cerebral Artery Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Center of Martinique'}, 'officialTitle': 'Randomized Therapeutic Study Assessing the Superiority of a Sequential Intravenous Thrombolysis Treatment (Rt-PA + Tenecteplase) in Comparison With Rt-PA Standard Treatment in Proximal Middle Cerebral Artery Occlusion (DIVA).', 'orgStudyIdInfo': {'id': '13/EC/02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'rt-PA', 'description': 'Patients treated by thrombolysis with rt -PA within 4h30 of the onset of symptoms to a proximal middle cerebral artery occlusion visible on a MRI 1 are pre- included. A second MRI ( IRM2 ) is performed between 1 hour and 1.5 hours after administration of rt-PA in the usual way .\n\nAfter the treatment by rt-PA, if there is no recanalization (TIMI score: 0,1, 2a), the patient is included. A patient included will be randomized either in the arm "rt-PA treatment only" or in the arm "rt-PA + tenecteplase treatment". If he is included in the arm "rt-PA only", he will not receive any other treatment for the study.', 'interventionNames': ['Drug: rt-PA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rt-PA + tenecteplase', 'description': 'If patient is in the arm "rt-PA + tenecteplase", he will receive tenecteplase (50UI/Kg) treatment. A third MRI will be performed at 24hour that will assess the recanalization status (TIMI), the final volume infarct and the hemorrhagic complications.', 'interventionNames': ['Drug: rt-PA', 'Drug: tenecteplase']}], 'interventions': [{'name': 'rt-PA', 'type': 'DRUG', 'otherNames': ['Actilyse'], 'description': '0,9 mg/kg of rt-PA is infused intravenously 60 minutes, with 10% of the total dose administered as an initial intravenous bolus.', 'armGroupLabels': ['rt-PA', 'rt-PA + tenecteplase']}, {'name': 'tenecteplase', 'type': 'DRUG', 'otherNames': ['Metalyse'], 'description': 'Tenecteplase is under the form of powder and solvent for solution for injection.\n\nThe maximum duration of this treatment is 15 seconds by a single bolus intravenous injection (0, 25 mg/kg).', 'armGroupLabels': ['rt-PA + tenecteplase']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Julien JOUX, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universiatire de Martinique'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Center of Martinique', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}