Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-26 @ 7:12 PM
Study NCT ID:
NCT06901466
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-27
First Post:
2025-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STrategies for AntithRombotic Treatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for Oral Anticoagulant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 880}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2025-03-23', 'studyFirstSubmitQcDate': '2025-03-23', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All bleeding complications at 1 year after TEER', 'timeFrame': '1 year', 'description': 'For the classification of bleeding complications, the Mitral Valve Academic Research Consortium (MVARC) Primary Bleeding Scale is used. All bleeding can be categorized into five types: minor bleeding, major bleeding, extensive bleeding, life-threatening bleeding, and fatal bleeding.'}], 'secondaryOutcomes': [{'measure': 'Non-procedure-related bleeding complications at 1 year after TEER（key secondary outcome 1）', 'timeFrame': '1 year', 'description': 'Non-procedure-related bleeding is consisted of all MVARC bleeding, excluding Bleeding Academic Research Consortium (BARC ) type 4 severe bleeding.BARC type 4 severe bleeding is defined by any of the following: perioperative intracranial bleeding within 48 hours, reoperation after closure of sternotomy for the purpose of controlling bleeding, transfusion of 5 or more units of whole blood or packed red cells within a 48-hour period, chest-tube output of 2 or more liters within a 24-hour period.'}, {'measure': 'Composite of ischemic event (1)(key secondary outcome 2)', 'timeFrame': '1 year', 'description': 'composite of all-cause mortality, stroke, systemic embolic events , or myocardial infarction at 1 year after TEER'}, {'measure': 'Composite of ischemic event (2)', 'timeFrame': '1 year', 'description': 'Composite of cardiovascular mortality, ischemic stroke, systemic embolic events ,or myocardial infarction at 1 year after TEER.'}, {'measure': 'Composite of ischemic and bleeding events（1）', 'timeFrame': '1 year', 'description': 'Composite of all bleeding, all-cause mortality, stroke, systemic embolic events or myocardial infarction at 1 year after TEER.'}, {'measure': 'Composite of ischemic and bleeding events（2）', 'timeFrame': '1 year', 'description': 'Composite of non-procedure-related bleeding events, cardiovascular mortality, ischemic stroke, systemic embolic events or myocardial infarction at 1 year after TEER.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcatheter Edge-to-Edge Repair (TEER)', 'Mitral Regurgitation', 'Cardiovascular Diseases', 'Embolism and Thrombosis', 'Bleeding', 'Aspirin', 'Rivaroxaban', 'Antithrombotic treatment', 'Oral anticoagulation', 'Platelet Aggregation Inhibitors', 'Stroke', 'Myocardial Infarction'], 'conditions': ['Mitral Regurgitation']}, 'descriptionModule': {'briefSummary': 'Mitral regurgitation (MR) is the most common valvular heart disease, affecting approximately 24.2 million people worldwide (with a higher prevalence in older age groups). Transcatheter edge-to-edge repair (TEER) is now a well-established strategy in high-risk patients with MR. Globally, over 250,000 patients have benefited from the TEER technique.Studies have shown that patients with severe mitral regurgitation exhibit a high prevalence of atrial fibrillation (AF), reaching up to 63%, which is an indication for long-term oral anticoagulation (OAC) therapy. However, no dedicated study has prospectively evaluated different antithrombotic strategies following TEER in patients with an indication for OAC. Current guidelines do not provide any recommendations for the antithrombotic management of TEER. Consequently, considerable treatment variation exists in clinical studies and practice. The investigators will conduct a multicenter, open-label randomized trial to compare different antithrombotic strategies following TEER in patients who have an indication for OAC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had undergone successful TEER (Defined as techinal success according to MVARC );\n* Need for long-term oral anticoagulation;\n* Ability to understand the requirements of the trial and willingness to comply with the trial protocol procedures;\n* Providing written informed consent form；\n* Women of childbearing potential must use an acceptable method of contraception from signing the informed consent form until the date of the last dose of antithrombotic drug;\n* The heart team agrees on the antithrombotic strategies.\n\nExclusion Criteria:\n\n* Severe renal impairment (creatinine clearance rate\\<15ml/min or on dialysis)；\n* Postoperative persistent bleeding (overt bleeding either associated with a drop in the hemoglobin of 3.0 g/dl or requiring transfusion of 3 U of whole blood or packed red blood cells) or occurrence of vascular complications；\n* Platelet count ≤ 30 ×10\\^9/L；\n* Need for reoperation；\n* History of intracranial or intracerebral hemorrhage；\n* History of gastrointestinal ulcers or hemorrhage；\n* Any hepatic disease associated with coagulopathy (Child-Pugh B or C);\n* Allergy, intolerance or contraindication to oral anticoagulation or antiplatelet drug;\n* History of cerebrovascular event or transient ischemic attack within the past 6 weeks;\n* Current antiplatelet therapy；\n* Patients who have participated in another drug or device investigational study within the past 30 days；\n* Life expectancy \\<12 months；\n* Pregnant or breastfeeding women。'}, 'identificationModule': {'nctId': 'NCT06901466', 'acronym': 'STAR-TEER Ⅰ', 'briefTitle': 'STrategies for AntithRombotic Treatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for Oral Anticoagulant', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'Strategies for Antithrombotic Treatment Following Transcatheter Edge-to-edge Repair in Patients With an Indication for Oral Anticoagulant: a Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025-2612'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rivaroxaban monotherapy', 'description': 'Participants will receive rivaroxaban according to its indication within 12 months after the TEER. For patients using OAC at baseline, the OAC therapy is intended to be continued during perioperative period.', 'interventionNames': ['Drug: Experimental: Rivaroxaban monotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rivaroxaban + Aspirin', 'description': 'Participants will receive aspirin (100mg qd, 6 months) on top of rivaroxaban (according to its indication, 12months).For patients using OAC at baseline, the OAC therapy is intended to be continued during perioperative period.', 'interventionNames': ['Drug: Active Comparator: Rivaroxaban+Aspirin']}], 'interventions': [{'name': 'Experimental: Rivaroxaban monotherapy', 'type': 'DRUG', 'description': 'Rivaroxaban monotherapy', 'armGroupLabels': ['Rivaroxaban monotherapy']}, {'name': 'Active Comparator: Rivaroxaban+Aspirin', 'type': 'DRUG', 'description': 'Rivaroxaban+Aspirin', 'armGroupLabels': ['Rivaroxaban + Aspirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Xiangbin Pan, MD,PhD', 'role': 'CONTACT', 'email': 'panxiangbin@fuwaihospital.org', 'phone': '86(10)88396666'}, {'name': 'Xiangbin Pan, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shouzheng Wang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiangbin Pan, MD,PhD', 'role': 'CONTACT', 'email': 'panxiangbin@fuwaihospital.org', 'phone': '+86(10)88396666'}, {'name': 'Zizheng Liu, M.B', 'role': 'CONTACT', 'email': 'liuzizheng00@126.com', 'phone': '+86(10)88396666'}], 'overallOfficials': [{'name': 'Xiangbin Pan, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, {'name': 'Shouzheng Wang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pan Xiangbin', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}}}}