Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-01-05 @ 3:07 AM
Study NCT ID:
NCT01452568
Status:
COMPLETED
Last Update Posted:
2014-08-05
First Post:
2009-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'C024079', 'term': 'aspirin, magnesium oxide combination'}, {'id': 'D014859', 'term': 'Warfarin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 370}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-04', 'studyFirstSubmitDate': '2009-09-22', 'studyFirstSubmitQcDate': '2011-10-14', 'lastUpdatePostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Haemorrhagic complications', 'timeFrame': '3 months', 'description': 'Bleeding complications'}, {'measure': 'Thromboembolic complications', 'timeFrame': '3 months', 'description': 'TCI, stroke, Myocardial infarction (MI), Pulmonary embolism, Deep vein thrombosis (DVT) , peripheral arterial embolism, intra-cardiac thrombus formation. We expected statistically fewer thromboembolic events in the groups receiving anticoagulation with warfarin than the aspirin only groups.'}], 'secondaryOutcomes': [{'measure': 'Echocardiographic findings before surgery, before discharge and 3 months after implantation', 'timeFrame': '3 months'}, {'measure': 'Registration of surgical data and postoperative complications', 'timeFrame': '3 months'}, {'measure': 'All cause mortality', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thromboembolic complications', 'Bleeding complications', 'Haemorrhagic complications', 'Anticoagulant therapy', 'Aspirin', 'biological Aorta Valve'], 'conditions': ['Thromboembolism', 'Bleeding']}, 'descriptionModule': {'briefSummary': 'The optimal medical strategy for prevention of thromboembolic events after bioprosthetic aorta valve replacement (BAVR) remains controversial.\n\nThe aim of this trial was to compare warfarin therapy (target INR of 2.0 to 3.0) against aspirin 150mg daily as antithrombotic therapy for the first three months after BAVR with or without concomitant coronary artery bypass grafting (CABG). The aim was to evaluate thromboembolic complications, bleeding complications and death.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients with aortic valve disease where there is indication for implantation of a biological stented aortic valve with or without coronary bypass surgery.\n* Age 60 years Sinus rhythm\n\nExclusion Criteria:\n\n* Patients planned for double valve surgery\n* Patients with active endocarditis\n* Patients with atrial fibrillation/flutter\n* Patients in anticoagulation treatment of other reason.\n* Patients with previous cerebrovascular accidents or insults.\n* Patients with TCI\n* Patients with hypercoagulable conditions, disseminated intervascular coagulation, haemophilia or any other blood coagulapathy or related condition, whereby the blood coagulation process is not readily controllable\n* Patients with pacemaker\n* Any other disease than valve disease that will considerably increase the operative risk and increase the probability that the patient dies within one year after the operation, for example because of terminal cancer\n* Patients that is HIV-positive or have active AIDS\n* Patients that are known drug abuser\n* Patients in chronic haemodialysis or other types of dialysis'}, 'identificationModule': {'nctId': 'NCT01452568', 'briefTitle': 'Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Early Anticoagulation Therapy After Bioprosthetic Aortic Valve Implantation: Comparing Warfarin Versus Aspirin', 'orgStudyIdInfo': {'id': '01-080/04'}, 'secondaryIdInfos': [{'id': '(KF) 01-080/04', 'type': 'OTHER', 'domain': 'Science Ethics Committee Copenhagen'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aspirin', 'description': 'Aspirin 150mg daily, starting day 1 after surgery, for three months.', 'interventionNames': ['Drug: Aspirin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Warfarin', 'description': 'Warfarin daily dosage to International normalized ratio(INR) value between 2,0 to 3,0.', 'interventionNames': ['Drug: Warfarin']}], 'interventions': [{'name': 'Aspirin', 'type': 'DRUG', 'otherNames': ['Magnyl, Acetyl salicylic acid'], 'description': '150mg/daily for three months, starting day after surgery', 'armGroupLabels': ['Aspirin']}, {'name': 'Warfarin', 'type': 'DRUG', 'otherNames': ['marevan'], 'description': 'Warfarin daily dosage to obtain an INR in between 2,0 to 3,0. Started the day after surgery and continued for three months.', 'armGroupLabels': ['Warfarin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Peter S Olsen, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen'}, {'name': 'Nikolaj B Lilleør', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen'}, {'name': 'Sulman Rafiq', 'role': 'STUDY_CHAIR', 'affiliation': 'Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Project Coordinator', 'investigatorFullName': 'Nikolaj B. Lilleoer', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}