[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100437826":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":35,"locations":39,"responsibleParty":44,"collaborators":47,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":39,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":73,"whyStopped":39,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":39},{"fullName":5,"class":6},"University Hospital, Geneva","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","EXPERIMENTAL","After a conventional course of 7 days of Apixaban 10mg BID, Apixaban 2.5mg BID during 3 months.",[13],"Drug: Apixaban 2.5 MG Oral Tablet [ELIQUIS]",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard","ACTIVE_COMPARATOR","After a conventional course of 7 days of Apixaban 10 mg BID, Apixaban 5 mg BID during 3 months.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Apixaban 2.5 MG Oral Tablet [ELIQUIS]","Apixaban 5 MG BID versus Apixaban 2.5 MG BID",[9,15],[26],"Apixaban 5 MG Oral Tablet",[28,32],{"name":29,"affiliation":30,"role":31},"Jean-Philippe Galanaud, MD, PhD","Sunnybrook Health Sciences Centre and University of Toronto, Toronto, Canada","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":34,"role":31},"Marc Righini, MD","Geneva University Hospital, Switzerland",[36,41],{"name":29,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","001",null,"Jean-Philippe.Galanaud@sunnybrook.ca",{"name":33,"role":37,"phone":42,"phoneExt":39,"email":43},"+41223729294","marc.righini@hcuge.ch",{"type":31,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Marc Righini","Full professor",[48],{"name":49,"class":6},"Sunnybrook Health Sciences Centre","100437826","phase-3-the-api-calf-study-apixaban-to-treat-calf-vein-thrombosis-100437826",false,"NCT04981327","The API-CALF Study: Apixaban to Treat Calf Vein Thrombosis","API-CALF","Inclusion Criteria:\n\nConsecutive patients with acute (symptoms \\\u003C10 days) symptomatic iDDVT diagnosed on leg CUS who have none of the following exclusion criteria and who provided informed consent to participate. Diagnosis of iDDVT is made in the presence of an incompressible distal deep vein (deep calf vein (posterior tibial, anterior tibial or peroneal veins) or muscular vein (soleal or gastrocnemius veins)).\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Ipsi or contralateral Proximal DVT\n* Distal DVT involving the tibio-peroneal trunk (i.e. calf trifurcation)\n* DVT occurring while on anticoagulation (started ≥48hours before DVT diagnosis); However, inpatients that developed their iDDVT while on prophylactic anticoagulation are eligible if their expected date of discharge is \\\u003C6 days post randomization.\n* Clinically suspected PE (patient eligible if PE ruled out with objective tests)\n* Active cancer, receiving cancer treatment or cured for \\\u003C 6 months\n* Indication for long-term therapeutic anticoagulation (e.g. atrial fibrillation, mechanical heart valve…)\n* Thrombocytopenia (platelet count \\\u003C100 g\u002Fl)\n* Severe renal impairment (creatinine clearance \\\u003C30 ml\u002Fmin)\n* Liver disease (including Child-Pugh Class B and C) associated with coagulopathy\n* Pregnant or breast-feeding woman\n* Body weight \\>120kg or \\\u003C40 kg\n* Ongoing active bleeding or condition at high risk of bleeding with anticoagulation (e.g. peptic ulcer…)\n* Treatment with daily NSAIDs (aspirin ≤160 mg\u002Fday or clopidogrel ≤75 mg day permitted)\n* Allergy to Apixaban\n* Use of concomitant drugs that significantly interact with Apixaban: strong inhibitors of P-gp and CYP3A4 or strong inducers of CYP3A4\n* Treatment with anticoagulants at therapeutic dose \\>2 days after DVT diagnosis\n* Life expectancy \\\u003C 1 year\n* Enrolled in another clinical trial within previous 30 days\n* Inability or refusal to provide informed consent","ALL","18 Years","120 Years",{"count":61,"type":62},1300,"ESTIMATED","INTERVENTIONAL",[65],"PHASE3","Isolated distal DVT (iDDVT) is the most frequent clinical presentation of VTE and is associated with a significant morbidity and risks of long-term complications. Data from clinical trials highlighted that patients with iDDVT might require some level of AC treatment. However, the optimal anticoagulant intensity is uncertain, and it is plausible that the best benefit\u002Frisk ratio for AC might be achieved with lower intensity doses rather than therapeutic doses.\n\nThe principal research question of the Apixaban to treat calf vein thrombosis (API-CALF) study is to determine whether, after a conventional course of 7 days of Apixaban 10mg BID, Apixaban 2.5mg BID (experimental arm) is non inferior to Apixaban 5 mg BID (standard arm) in preventing VTE recurrence and bleeding in patients with iDDVT. Patients will be treated with Apixaban for a total of 3 months. In that perspective we will conduct an international multicentre open-label assessor-blinded study",[68],"Deep Vein Thrombosis",[70,71,72],"Isolated distal deep vein thrombosis","Anticoagulation","Direct oral anticoagulants","NOT_YET_RECRUITING","2021-07-22",{"date":76,"type":77},"2021-07-29","ACTUAL",{"date":79,"type":62},"2022-09-01",{"date":81,"type":62},"2027-08-31",{"name":5,"class":6}]