Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT07205250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aspirin for Stroke Prevention After Endovascular Aortic Arch Repair: A Multicenter, Double-Blind, Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013607', 'term': 'Tablets'}, {'id': 'D013649', 'term': 'Taste'}, {'id': 'D012903', 'term': 'Smell'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D012677', 'term': 'Sensation'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This study employs a double-blind approach with a two-tier blinding system:Tier 1 Blinding: Medication codes (e.g., XX series = Group A, XX series = Group B)，Tier 2 Blinding: Concealment of group assignments corresponding to each code，Emergency unblinding will be implemented if either of the following occurs:Development of severe complications，Occurrence of adverse events requiring clinical intervention that may affect trial continuation. All unblinded cases will be managed as study discontinuations.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly divided into two groups: the aspirin group and the placebo group. On the first postoperative day, patients in the aspirin group will begin oral administration of enteric-coated aspirin tablets (100 mg once daily, Bayer Healthcare, specification: 100 mg/tablet). Patients in the placebo group will receive a placebo with identical or similar appearance, taste, smell, and packaging to the aspirin tablets. The oral medication course will last for six months.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 538}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2025-09-25', 'studyFirstSubmitQcDate': '2025-09-25', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of postoperative stroke.', 'timeFrame': 'After one year', 'description': 'yes or no'}], 'secondaryOutcomes': [{'measure': 'Patency rate of reconstructed branch vessels,', 'timeFrame': 'After one year', 'description': 'yes or no'}, {'measure': 'incidence of major postoperative bleeding complications,', 'timeFrame': 'After one year', 'description': 'yes or no'}, {'measure': 'incidence of complications related to endovascular aortic arch repair (e.g., thrombosis, bleeding, infection),', 'timeFrame': 'After one year', 'description': 'yes or no'}, {'measure': 'incidence of postoperative cognitive impairment.', 'timeFrame': 'After one year', 'description': 'yes or no'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type B or Non-A Non-B Aortic Dissection;Thoracic Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': "Abstract Introduction: Endovascular aortic arch repair (EAAR) and endovascular reconstruction of arch branch vessels have emerged as a new trend in treating aortic arch pathologies due to their advantages of minimal invasiveness, faster recovery, and fewer complications. Stroke is a common and severe complication during EAAR procedures; however, preventive strategies and the necessity of postoperative antiplatelet therapy remain unreported.\n\nMethods and analysis: This project aims to conduct a prospective, multicenter, double-masked randomized controlled study. Patients undergoing EAAR will be randomly assigned to either an aspirin or a placebo group, receiving six months of aspirin or placebo treatment postoperatively. Both groups will be followed up for over one year, with the primary outcome being the incidence of postoperative stroke. Secondary outcomes include the patency rate of reconstructed branch vessels, the incidence of major bleeding complications, EAAR-related complications, and postoperative cognitive impairment. The study will evaluate the efficacy and safety of aspirin in preventing stroke after EAAR.\n\nFurthermore, through stratified analysis, the study will explore the impact of different reconstruction techniques, the number of reconstructed branch arteries, and the diameter of branch stents on postoperative stroke rates. It will also assess the value of aspirin in different subgroups, aiming to provide more precise clinical strategies for prevention and treatment.\n\nEthics and dissemination:（Mandatory pre-implementation review by the Institutional Review Board (IRB) of Western Theater Command General Hospital ensures full compliance with national ethical standards and regulatory requirements.\n\nAll research personnel must adhere strictly to ethical principles and assume full accountability for protecting participant rights and monitoring ongoing safety. The trial's results will be disseminated through academic conferences and journal publications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients aged 18 years or older;\n2. Diagnosed with type B or non-A non-B aortic dissection or thoracic aortic aneurysm according to the 2022 Chinese Expert Consensus on Stanford Type B Aortic Dissection;\n3. Underwent total endovascular aortic arch repair at the participating center with concurrent intraoperative endovascular reconstruction of supra-arch branch arteries;\n4. Signed the informed consent form and agreed to participate in this randomized controlled trial.\n\nExclusion Criteria\n\n1. Patients with known allergies to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs);\n2. Patients with bleeding tendencies or active bleeding;\n3. Patients who used medications affecting coagulation (e.g., warfarin, antiplatelet drugs) within 30 days before surgery;\n4. Patients with a history of stroke;\n5. Patients undergoing concurrent additional surgical procedures during the operation;\n6. Patients with severe multi-organ dysfunction or other critical illnesses;\n7. Patients unable to comply with study protocols or complete postoperative follow-up;\n8. Patients participating in other drug or clinical studies that may interfere with the results of this research.'}, 'identificationModule': {'nctId': 'NCT07205250', 'briefTitle': 'Aspirin for Stroke Prevention After Endovascular Aortic Arch Repair: A Multicenter, Double-Blind, Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'The General Hospital of Western Theater Command'}, 'officialTitle': 'WesternTheaterCommand', 'orgStudyIdInfo': {'id': 'WWWesternTheaterCommand'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the aspirin tablets1', 'description': 'Patients will be randomly divided into two groups: the aspirin group and the placebo group. Patients in the aspirin group will begin oral administration of enteric-coated aspirin tablets (100 mg once daily, Bayer Healthcare, specification: 100 mg/tablet) on the first postoperative day. The oral medication course will last for six months.', 'interventionNames': ['Drug: enteric-coated aspirin tablets (100 mg once daily, Bayer Healthcare, specification: 100 mg/tablet)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'the aspirin tablets2', 'description': 'Patients in the placebo group will receive a placebo with identical or similar appearance, taste, smell, and packaging to the aspirin tablets. The oral medication course will last for six months.', 'interventionNames': ['Other: a placebo with identical or similar appearance, taste, smell, and packaging to the aspirin tablets']}], 'interventions': [{'name': 'enteric-coated aspirin tablets (100 mg once daily, Bayer Healthcare, specification: 100 mg/tablet)', 'type': 'DRUG', 'description': 'Patients will be randomly divided into two groups: the aspirin group and the placebo group. Patients in the aspirin group will begin oral administration of enteric-coated aspirin tablets (100 mg once daily, Bayer Healthcare, specification: 100 mg/tablet) on the first postoperative day. Patients in the placebo group will receive a placebo with identical or similar appearance, taste, smell, and packaging to the aspirin tablets. The oral medication course will last for six months.', 'armGroupLabels': ['the aspirin tablets1']}, {'name': 'a placebo with identical or similar appearance, taste, smell, and packaging to the aspirin tablets', 'type': 'OTHER', 'description': 'Patients will be randomly divided into two groups: the aspirin group and the placebo group. Patients in the aspirin group will begin oral administration of enteric-coated aspirin tablets (100 mg once daily, Bayer Healthcare, specification: 100 mg/tablet) on the first postoperative day. Patients in the placebo group will receive a placebo with identical or similar appearance, taste, smell, and packaging to the aspirin tablets. The oral medication course will last for six months.', 'armGroupLabels': ['the aspirin tablets2']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wei Wu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident doctor', 'investigatorFullName': 'Wei Wu', 'investigatorAffiliation': 'The General Hospital of Western Theater Command'}}}}