[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546585":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":51,"centralContacts":55,"locations":47,"responsibleParty":61,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":47,"enrollmentInfo":77,"targetDuration":47,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":91,"whyStopped":47,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":47},{"fullName":5,"class":6},"Brazilian Clinical Research Institute","OTHER",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","ACTIVE_COMPARATOR","rivaroxaban 2.5 mg Twice a day (BID) + colchicine 0.5 mg once daily (QD)",[13,14],"Drug: Rivaroxaban 2.5 Mg Oral Tablet","Drug: Colchicine 0.5 MG",{"label":16,"type":10,"description":17,"interventionNames":18},"Group 2","rivaroxaban 2.5 mg BID + colchicine placebo QD",[13,19],"Drug: Placebo Colchicine",{"label":21,"type":10,"description":22,"interventionNames":23},"Group 3","rivaroxaban placebo BID + colchicine 0.5 mg QD",[14,24],"Drug: Placebo Rivaroxaban",{"label":26,"type":27,"description":28,"interventionNames":29},"Group 4","PLACEBO_COMPARATOR","rivaroxaban placebo BID + colchicine placebo QD",[24,19],[31,38,44,48],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Rivaroxaban 2.5 Mg Oral Tablet","Patients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months.",[9,16],[37],"Xarelto",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Colchicine 0.5 MG","Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.",[9,21],[43],"Colchis",{"type":32,"name":45,"description":34,"armGroupLabels":46,"otherNames":47},"Placebo Rivaroxaban",[21,26],null,{"type":32,"name":49,"description":40,"armGroupLabels":50,"otherNames":47},"Placebo Colchicine",[16,26],[52],{"name":53,"affiliation":5,"role":54},"Renato D Lopes, MD, PhD","STUDY_CHAIR",[56],{"name":57,"role":58,"phone":59,"phoneExt":47,"email":60},"Remo Furtado, MD, PhD","CONTACT","55 11 59047339","remo.furtado@bcri.org.br",{"type":62,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR",[64],{"name":65,"class":66},"Alliança Diagnostic","UNKNOWN","100546585","phase-4-anti-inflammatory-and-anti-thrombotic-therapy-with-colchicine-and-low-dose-rivaroxaban-for-major-adverse-cardiovascular-events-reduction-in-ischemic-stroke-100546585",false,"NCT06396858","Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke","A 2 x 2 Factorial Randomized Clinical Trial Evaluating Anti-inflammatory and Anti-thrombotic Strategy in Acute Ischemic Stroke","ARCHIMEDES","Inclusion Criteria:\n\n* Patients with acute ischemic stroke aged ≥18 years old who, regardless of etiology and mechanism, do not have a definitive indication for anticoagulation, and whose symptoms onset has been within the last 14 days;\n* Receiving standard therapy for acute management of ischemic stroke;\n* For patients treated with fibrinolytics, a minimum period of 24 hours after the infusion of the lytic drug is required for randomization into the study.\n\nExclusion Criteria:\n\n* Modified Rankin score of 4 or more at randomization;\n* Refusal to provide consent;\n* Severe renal failure, with glomerular filtration rate (by CKD-EPI) estimated at \\\u003C15 mL\u002Fmin\u002F1.73 m2;\n* Severe liver failure (child C);\n* Indication for full-dose anticoagulation (for example, venous thromboembolism or atrial fibrillation);\n* Previous hemorrhagic stroke or history of intracranial hemorrhage;\n* Systemic treatment with a potent CYP 3A4 inhibitor (such as azole antifungals and protease inhibitors), or with a potent 3A4 inducer (such as rifampicin, phenytoin, phenobarbital, or carbamazepine);\n* History of inflammatory bowel disease or chronic diarrhea;\n* Prolonged treatment (\\> 1 month) with immunosuppressants or systemic corticosteroids;\n* History of recurrent pneumonia (3 or more hospitalizations in the last 12 months);\n* Pregnancy or breastfeeding;\n* Any other comorbidity other than stroke and CV disease (e.g., metastatic cancer) that, in the investigator's opinion, has a significant impact on the 12-month survival.","ALL","18 Years",{"count":78,"type":79},4500,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","The ARCHIMEDES study (Anti-inflammatory and anti-thRombotic therapy with colCHicine and low dose rIvaroxaban for Major adverse cardiovascular Events reDuction in ischEmic Stroke) will be a randomized, double-blind, 2x2 factorial clinical trial, which will include at least 3000 and up to a maximum of 4500 patients with ischemic stroke without indication of oral anticoagulation.",[85],"Ischemic Stroke",[87,88,89,90],"Stroke","Anticoagulation","rivaroxaban","colchicine","NOT_YET_RECRUITING","2026-02-10",{"date":94,"type":95},"2026-02-11","ACTUAL",{"date":97,"type":79},"2026-07",{"date":99,"type":79},"2027-12",{"name":5,"class":6}]