[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461607":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":40,"responsibleParty":73,"collaborators":24,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":24,"enrollmentInfo":85,"targetDuration":24,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":24,"overallStatus":43,"whyStopped":24,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Ottawa Hospital Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High thrombotic risk","EXPERIMENTAL","For patients at high thrombotic risk, DOACs will be resumed within 7 days of clinical hemostasis after GI bleeding.",[13],"Other: Restart DOAC within 7 days of clinical hemostasis after GI bleeding",{"label":15,"type":10,"description":16,"interventionNames":17},"Moderate thrombotic risk","For patients at moderate thrombotic risk, DOACs will be resumed between 7 and 14 days of clinical hemostasis after GI bleeding.",[18],"Other: Restart DOAC between 7 to 14 days of clinical hemostasis after GI bleeding",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Restart DOAC within 7 days of clinical hemostasis after GI bleeding","In patients at high thrombotic risk, DOACs will be resumed within 7 days of clinical hemostasis (as judged by the clinical team).\n\nHigh thrombotic risk includes the following:\n\n(i) Atrial fibrillation or atrial flutter with CHA2DS2VASc score of 5 or higher (ii) Atrial fibrillation or atrial flutter with CHA2DS2VASc score or 3 to 4 with recent ischemic stroke, TIA or systemic embolism (within 6 months) (iii) VTE (proximal DVT or PE) within 3 months (iv) Recurrent VTE (proximal DVT or PE) (v) VTE (proximal DVT or PE) associated with antiphospholipid syndrome (if eligible for DOAC) (vi) VTE (proximal DVT or PE) associated with active non-GI cancer (vii) None of the above but considered high thrombotic risk as per investigator",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Restart DOAC between 7 to 14 days of clinical hemostasis after GI bleeding","In patients at moderate thrombotic risk, DOACs will be resumed between 7 and 14 days of clinical hemostasis (as judged by the clinical team).\n\nModerate thrombotic risk includes the following:\n\n(i) Atrial fibrillation or atrial flutter with CHA2DS2VASc score of 3 to 4 (ii) VTE (proximal DVT or PE) beyond 3 months\n\nThe type and dose of DOAC will be according to patient and physician choice and will be prescribed by the clinical care team.",[15],[30],{"name":31,"affiliation":5,"role":32},"Deborah M Siegal, MD MSc","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Deborah M Siegal, MD","CONTACT","613-737-8899","78804","dsiegal@toh.ca",[41,60],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Alberta Health Services - Peter Lougheed Center Endoscopy Unit","RECRUITING","Calgary","Alberta","T1Y 6J4","Canada","CA",{"type":50,"coordinates":51},"Point",[52,53],-114.08529,51.05011,{"lat":53,"lon":52},[56],{"name":57,"role":36,"phone":58,"phoneExt":24,"email":59},"Nauzer Forbes, MD","(403) 943-4219","nauzer.forbes@ucalgary.ca",{"facility":5,"status":43,"city":61,"state":62,"zip":63,"country":47,"countryCode":48,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Ottawa","Ontario","K1H8L6",{"type":50,"coordinates":65},[66,67],-75.69812,45.41117,{"lat":67,"lon":66},[70],{"name":71,"role":36,"phone":72,"phoneExt":38,"email":39},"Deborah Siegal, MD","6137378899",{"type":74,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100461607","anticoagulation-after-gi-bleeding-pilot-study-and-registry-100461607",false,"NCT05290857","Anticoagulation After GI Bleeding Pilot Study and Registry","Post-Bleed Management of Antithrombotic Therapy After Gastrointestinal Bleeding: Pilot Study and Registry (PANTHER-GI)","PANTHER-GI","Inclusion Criteria:\n\n1. Male or female subjects aged 18 years or older\n2. Hospitalized with acute major non-variceal GI bleeding (defined as per ISTH criteria) while receiving OAC therapy (warfarin or DOAC).\n3. OAC therapy discontinued for current acute GI bleed and not yet resumed\n4. Ongoing indication for long-term anticoagulation of atrial fibrillation (moderate to high risk of stroke\u002Fsystemic embolism with CHA2DS2VASc score of 3 or higher) or VTE (as per clinical care team)\n5. Planned to resume DOAC post-bleed\n6. At moderate to high risk of re-bleeding as per clinical care team\n7. Clinical hemostasis achieved as per clinical care team\n8. Able and willing to comply with follow-up examinations contained within the consent form\n\nExclusion Criteria:\n\n1. Mechanical heart valve\n2. VTE in the context of major transient risk factor and completed 3 months of treatment\n3. GI bleeding managed surgically (e.g. gastrectomy, colectomy)\n4. Active or previously treated gastrointestinal cancer\n5. Life expectancy from other causes of less than 3 months\n6. Platelet count \\\u003C 50,000\u002FµL (or \\\u003C 50x109\u002FL)\n7. Renal dysfunction (Creatine Clearance \\\u003C30 mL\u002Fmin as calculated by the Cockcroft-Gault formula)","ALL","18 Years",{"count":86,"type":87},100,"ESTIMATED","INTERVENTIONAL",[90],"NA","PANTHER-GI Pilot Study will assess the feasibility of a full-scale multicentre cohort management study evaluating the safety of a standardized strategy for resuming direct oral anticoagulants (DOACs) after major DOAC-related gastrointestinal (GI) bleeding among patients at moderate to high risk of re-bleeding and thrombosis. A parallel registry will assess whether eligible patients who are not enrolled in the PANTHER-GI Pilot Study are systematically different than enrolled patients and to explore barriers to enrolment.",[93,94],"GastroIntestinal Bleeding","Anticoagulant-induced Bleeding","2025-07-28",{"date":97,"type":98},"2025-07-30","ACTUAL",{"date":100,"type":98},"2022-03-31",{"date":102,"type":87},"2025-12",{"name":5,"class":6},2]