[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546585":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":59,"studyPopulation":50,"armGroups":60,"interventions":83,"overallOfficials":103,"centralContacts":107,"locations":50,"responsibleParty":113,"collaborators":115,"id":119,"slug":50,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":120,"sex":126,"minAge":127,"maxAge":50,"enrollmentInfo":128,"targetDuration":50,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":142,"whyStopped":50,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":50},{"fullName":5,"class":6},"Brazilian Clinical Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":33},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Primary efficacy endpoint: Time to cardiovascular death, stroke, myocardial infarction (MI), or urgent arterial","Time to cardiovascular death, stroke, myocardial infarction (MI), or urgent arterial revascularization","12 months",{"measure":14,"description":15,"timeFrame":12},"Primary safety endpoint (rivaroxaban versus placebo): Time to major bleeding according to the International Society of Thrombosis and Hemostasis classification","Time to major bleeding according to the International Society of Thrombosis and Hemostasis classification",{"measure":17,"description":18,"timeFrame":12},"Primary safety endpoint (colchicine versus placebo): Hospitalization for respiratory infections","Time to first hospitalization for respiratory infections",[20,22,24,26,28,31],{"measure":21,"description":21,"timeFrame":12},"Time to fatal or non-fatal stroke",{"measure":23,"description":23,"timeFrame":12},"Time to CV death, MI, or stroke",{"measure":25,"description":25,"timeFrame":12},"Time to death from all causes, MI, or stroke",{"measure":27,"description":27,"timeFrame":12},"Time to fatal or non-fatal stroke, death, or transient ischemic attack",{"measure":29,"description":30,"timeFrame":12},"Net clinical endpoint: time to CV death, MI, stroke, fatal bleeding, or critical site bleeding","Time to CV death, MI, stroke, fatal bleeding, or critical site bleeding",{"measure":32,"description":32,"timeFrame":12},"Time to all-cause death",[34,37,40,43],{"measure":35,"description":36,"timeFrame":12},"modified Rankin score","modified Rankin score as ordinal outcome",{"measure":38,"description":39,"timeFrame":12},"Venous thromboembolism","Time to first venous thromboembolism",{"measure":41,"description":42,"timeFrame":12},"New-onset atrial fibrillation","time to new-onset atrial fibrillation",{"measure":44,"description":44,"timeFrame":12},"Microvascular obstruction at head MRI (substudy)",{"allocation":46,"interventionModel":47,"interventionModelDescription":48,"primaryPurpose":49,"observationalModel":50,"timePerspective":50,"maskingInfo":51},"RANDOMIZED","FACTORIAL","they will be randomized, simultaneously, in a 1:1 ratio, to rivaroxaban 2.5 mg BID or placebo, and colchicine 0.5 mg QD versus placebo, in a 2x2 factorial design. Therefore, the study will have four possible groups: rivaroxaban 2.5 mg BID + colchicine 0.5 mg QD; rivaroxaban 2.5 mg BID + colchicine placebo QD; rivaroxaban placebo BID + colchicine 0.5 mg QD; or rivaroxaban placebo BID + colchicine placebo QD","PREVENTION",null,{"masking":52,"maskingDescription":53,"whoMasked":54},"QUADRUPLE","Matching placebos will be produced for rivaroxaban and colchicine.",[55,56,57,58],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","In patients with ischemic stroke, within 14 days of symptom onset, to establish the efficacy and safety of two strategies in parallel: low-dose rivaroxaban and low-dose colchicine, compared with placebo.",[61,68,73,78],{"label":62,"type":63,"description":64,"interventionNames":65},"Group 1","ACTIVE_COMPARATOR","rivaroxaban 2.5 mg Twice a day (BID) + colchicine 0.5 mg once daily (QD)",[66,67],"Drug: Rivaroxaban 2.5 Mg Oral Tablet","Drug: Colchicine 0.5 MG",{"label":69,"type":63,"description":70,"interventionNames":71},"Group 2","rivaroxaban 2.5 mg BID + colchicine placebo QD",[66,72],"Drug: Placebo Colchicine",{"label":74,"type":63,"description":75,"interventionNames":76},"Group 3","rivaroxaban placebo BID + colchicine 0.5 mg QD",[67,77],"Drug: Placebo Rivaroxaban",{"label":79,"type":80,"description":81,"interventionNames":82},"Group 4","PLACEBO_COMPARATOR","rivaroxaban placebo BID + colchicine placebo QD",[77,72],[84,91,97,100],{"type":85,"name":86,"description":87,"armGroupLabels":88,"otherNames":89},"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.",[62,69],[90],"Xarelto",{"type":85,"name":92,"description":93,"armGroupLabels":94,"otherNames":95},"Colchicine 0.5 MG","Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.",[62,74],[96],"Colchis",{"type":85,"name":98,"description":87,"armGroupLabels":99,"otherNames":50},"Placebo Rivaroxaban",[74,79],{"type":85,"name":101,"description":93,"armGroupLabels":102,"otherNames":50},"Placebo Colchicine",[69,79],[104],{"name":105,"affiliation":5,"role":106},"Renato D Lopes, MD, PhD","STUDY_CHAIR",[108],{"name":109,"role":110,"phone":111,"phoneExt":50,"email":112},"Remo Furtado, MD, PhD","CONTACT","55 11 59047339","remo.furtado@bcri.org.br",{"type":114,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR",[116],{"name":117,"class":118},"Alliança Diagnostic","UNKNOWN","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":129,"type":130},4500,"ESTIMATED","INTERVENTIONAL",[133],"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.",[136],"Ischemic Stroke",[138,139,140,141],"Stroke","Anticoagulation","rivaroxaban","colchicine","NOT_YET_RECRUITING","2026-02-10",{"date":145,"type":146},"2026-02-11","ACTUAL",{"date":148,"type":130},"2026-07",{"date":150,"type":130},"2027-12",{"name":5,"class":6}]