Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-02-21 @ 2:55 PM
Study NCT ID:
NCT02211066
Status:
COMPLETED
Last Update Posted:
2019-12-19
First Post:
2014-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TIcaGrEloR and ABSORB Bioresorbable Vascular Scaffold Implantation for Recovery of Vascular Function After Successful Chronic Total Occlusion Recanalization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D000077486', 'term': 'Ticagrelor'}], 'ancestors': [{'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-18', 'studyFirstSubmitDate': '2014-07-28', 'studyFirstSubmitQcDate': '2014-08-05', 'lastUpdatePostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in increase of coronary blood flow (CBF) under adenosine administration from baseline in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group.', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline in mean lumen diameter after nitrate administration in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group.', 'timeFrame': 'Baseline'}, {'measure': 'Changes from baseline in coronary flow reserve after adenosine administration in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group.', 'timeFrame': 'Baseline'}, {'measure': 'Changes from baseline in mean lumen diameter after nitrate administration in the coronary segment scaffolded by ABSORB and in that distal to it at 1 year follow-up between the ticagrelor vs. clopidogrel group.', 'timeFrame': '1 year'}, {'measure': 'Changes from baseline in coronary blood flow after adenosine administration in the coronary segment distal to the scaffold implanted at 1-year follow-up between the ticagrelor vs. clopidogrel group', 'timeFrame': '1 year'}, {'measure': 'Changes from baseline in coronary flow reserve after adenosine administration in the coronary segment distal to the scaffold implanted at 1-year follow-up between the ticagrelor vs. clopidogrel group.', 'timeFrame': '1 year'}, {'measure': 'Changes from baseline in mean lumen diameter after nitrate administration in the coronary segment scaffolded by ABSORB and in that distal to it at 3-year follow-up between the ticagrelor vs. clopidogrel group.', 'timeFrame': '3 years'}, {'measure': 'Changes from baseline in coronary blood flow after adenosine administration in the coronary segment distal to the scaffold implanted at 3-year follow-up between the ticagrelor vs. clopidogrel group.', 'timeFrame': '3 years'}, {'measure': 'Changes from baseline in coronary flow reserve after adenosine administration in the coronary segment distal to the scaffold implanted at 3-year follow-up between the ticagrelor vs. clopidogrel group.', 'timeFrame': '3 years'}, {'measure': 'Difference in intimal-media thickness at the site of scaffold implanted, evaluated by optical coherence tomography in a subgroup of patients at 1-year follow-up between the ticagrelor vs. clopidogrel group.', 'timeFrame': '1 year'}, {'measure': 'Difference in intimal-media thickness at the site of scaffold implanted, evaluated by optical coherence tomography at 3 years follow-up between the ticagrelor vs. clopidogrel group.', 'timeFrame': '3 years'}, {'measure': 'Clinical endpoints at 1 and 3 years follow-up: cardiac death, probable or definite scaffold thrombosis, target vessel failure, bleeding.', 'timeFrame': '1 and 3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patients Who Are Scheduled to Undergo a PCI (Percutaneous Coronary Intervention) for CTO (Chronic Total Occlusion)']}, 'referencesModule': {'references': [{'pmid': '34238679', 'type': 'DERIVED', 'citation': 'Rodriguez-Arias JJ, Gomez-Lara J, Caballero-Borrego J, Ortega-Paz L, Arevalos V, Teruel L, Gil-Jimenez T, Oyarzabal L, Romaguera R, Moreno-Terribas G, Gomez-Hospital JA, Sabate M, Brugaletta S. Long-Term Vascular Function in CTO Recanalization: A Randomized Clinical Trial of Ticagrelor vs. Clopidogrel. Cardiovasc Revasc Med. 2022 Apr;37:61-67. doi: 10.1016/j.carrev.2021.06.129. Epub 2021 Jul 1.'}, {'pmid': '28707316', 'type': 'DERIVED', 'citation': 'Brugaletta S, Gomez-Lara J, Caballero J, Ortega-Paz L, Teruel L, Jimenez Fernandez M, Romaguera R, Alcalde Martinez V, Nato M, Molina Navarro E, Gomez-Hospital JA, Correa Vilches C, Joyera M, Cequier A, Sabate M. TIcaGrEloR and Absorb bioresorbable vascular scaffold implantation for recovery of vascular function after successful chronic total occlusion recanalization (TIGER-BVS trial): Rationale and study design. Catheter Cardiovasc Interv. 2018 Jan 1;91(1):1-6. doi: 10.1002/ccd.27196. Epub 2017 Jul 14.'}]}, 'descriptionModule': {'briefSummary': 'The study is a single-centre, randomized, active controlled, open label clinical trial. The primary hypothesis is that ticagrelor will show superiority over clopidogrel immediately after CTO-PCI (chronic total occlusion - percutaneous coronary intervention)', 'detailedDescription': 'The hypothesis is tested in the first randomization. Both antiplatelet therapy will be used in both arms at the approved doses and for the approved duration therapy of 1-year. The secondary hypothesis will test the role of ticagrelor/clopidogrel alone and together with ABSORB BVS implantation in the recovery of vascular function at long-term. This hypothesis is tested in the second randomization. The angiographic follow-up will be scheduled at 1 or 3-year follow-up in order to test the secondary hypothesis either at the moment of the end of the antiplatelet therapy or at the moment of scaffold bioresorption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients of both sexes, older than 18 years old.\n* Written informed consent obtained.\n* Patients with stable angina pectoris (Canadian Cardiovascular Society (CCS) Class 1, 2, 3 or 4) or patients with documented silent ischemia by stress test during the last year.\n* Patients eligible for coronary revascularization in a coronary chronic total occlusion, which was angiographically documented in a previous coronary angiography during the last year.\n\nExclusion Criteria:\n\n* Women who are pregnant or women of childbearing potential who do not use adequate contraception.\n* Known allergies to aspirin, clopidogrel bisulfate (Plavix ®), ticagrelor (BriliqueTM) heparin, or a sensitivity to contrast media, which cannot be adequately pre-medicated.\n* Participation in other studies.\n* Life expectancy of less than one year or factors making clinical and/or angiographic follow-up difficult.\n* Planned cardiac surgery or major non-cardiac surgery.\n* The subject has a history of bleeding diathesis or coagulopathy.\n* The subject suffered disabling stroke within the past year.\n* Known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine dysfunction, which, in the judgment of the Investigator, may affect the patient's ability to complete the study.\n* History of malignancy, except in patients who have been disease-free \\>5 years or whose only malignancy has been basal or squamous cell skin carcinoma.\n* Inability to provide informed consent"}, 'identificationModule': {'nctId': 'NCT02211066', 'acronym': 'TIGER-BVS', 'briefTitle': 'TIcaGrEloR and ABSORB Bioresorbable Vascular Scaffold Implantation for Recovery of Vascular Function After Successful Chronic Total Occlusion Recanalization', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'TIcaGrEloR and ABSORB Bioresorbable Vascular Scaffold Implantation for Recovery of Vascular Function After Successful Chronic Total Occlusion Recanalization', 'orgStudyIdInfo': {'id': 'TIGER-BVS'}, 'secondaryIdInfos': [{'id': '2013-002675-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Clopidogrel', 'description': 'Clopidogrel 75 mg will be administered daily for 1 year', 'interventionNames': ['Drug: Clopidogrel']}, {'type': 'EXPERIMENTAL', 'label': 'Ticagrelor', 'description': 'Ticagrelor 90 mg will be administered daily for 1 year', 'interventionNames': ['Drug: Ticagrelor']}], 'interventions': [{'name': 'Clopidogrel', 'type': 'DRUG', 'armGroupLabels': ['Clopidogrel']}, {'name': 'Ticagrelor', 'type': 'DRUG', 'armGroupLabels': ['Ticagrelor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Salvatore Brugaletta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Trial Manager', 'investigatorFullName': 'Juan A. Arnaiz', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}