Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:18 PM
Study NCT ID:
NCT06396858
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-21
First Post:
2024-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'D003078', 'term': 'Colchicine'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000470', 'term': 'Alkaloids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Matching placebos will be produced for rivaroxaban and colchicine.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4500}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2024-01-04', 'studyFirstSubmitQcDate': '2024-04-29', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'modified Rankin score', 'timeFrame': '12 months', 'description': 'modified Rankin score as ordinal outcome'}, {'measure': 'Venous thromboembolism', 'timeFrame': '12 months', 'description': 'Time to first venous thromboembolism'}, {'measure': 'New-onset atrial fibrillation', 'timeFrame': '12 months', 'description': 'time to new-onset atrial fibrillation'}, {'measure': 'Microvascular obstruction at head MRI (substudy)', 'timeFrame': '12 months', 'description': 'Microvascular obstruction at head MRI (substudy)'}], 'primaryOutcomes': [{'measure': 'Primary efficacy endpoint: Time to cardiovascular death, stroke, myocardial infarction (MI), or urgent arterial', 'timeFrame': '12 months', 'description': 'Time to cardiovascular death, stroke, myocardial infarction (MI), or urgent arterial revascularization'}, {'measure': 'Primary safety endpoint (rivaroxaban versus placebo): Time to major bleeding according to the International Society of Thrombosis and Hemostasis classification', 'timeFrame': '12 months', 'description': 'Time to major bleeding according to the International Society of Thrombosis and Hemostasis classification'}, {'measure': 'Primary safety endpoint (colchicine versus placebo): Hospitalization for respiratory infections', 'timeFrame': '12 months', 'description': 'Time to first hospitalization for respiratory infections'}], 'secondaryOutcomes': [{'measure': 'Time to fatal or non-fatal stroke', 'timeFrame': '12 months', 'description': 'Time to fatal or non-fatal stroke'}, {'measure': 'Time to CV death, MI, or stroke', 'timeFrame': '12 months', 'description': 'Time to CV death, MI, or stroke'}, {'measure': 'Time to death from all causes, MI, or stroke', 'timeFrame': '12 months', 'description': 'Time to death from all causes, MI, or stroke'}, {'measure': 'Time to fatal or non-fatal stroke, death, or transient ischemic attack', 'timeFrame': '12 months', 'description': 'Time to fatal or non-fatal stroke, death, or transient ischemic attack'}, {'measure': 'Net clinical endpoint: time to CV death, MI, stroke, fatal bleeding, or critical site bleeding', 'timeFrame': '12 months', 'description': 'Time to CV death, MI, stroke, fatal bleeding, or critical site bleeding'}, {'measure': 'Time to all-cause death', 'timeFrame': '12 months', 'description': 'Time to all-cause death'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Anticoagulation', 'rivaroxaban', 'colchicine'], 'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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 \\<15 mL/min/1.73 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."}, 'identificationModule': {'nctId': 'NCT06396858', 'acronym': 'ARCHIMEDES', 'briefTitle': 'Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Brazilian Clinical Research Institute'}, 'officialTitle': 'A 2 x 2 Factorial Randomized Clinical Trial Evaluating Anti-inflammatory and Anti-thrombotic Strategy in Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': '001/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'rivaroxaban 2.5 mg Twice a day (BID) + colchicine 0.5 mg once daily (QD)', 'interventionNames': ['Drug: Rivaroxaban 2.5 Mg Oral Tablet', 'Drug: Colchicine 0.5 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'rivaroxaban 2.5 mg BID + colchicine placebo QD', 'interventionNames': ['Drug: Rivaroxaban 2.5 Mg Oral Tablet', 'Drug: Placebo Colchicine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': 'rivaroxaban placebo BID + colchicine 0.5 mg QD', 'interventionNames': ['Drug: Colchicine 0.5 MG', 'Drug: Placebo Rivaroxaban']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 4', 'description': 'rivaroxaban placebo BID + colchicine placebo QD', 'interventionNames': ['Drug: Placebo Rivaroxaban', 'Drug: Placebo Colchicine']}], 'interventions': [{'name': 'Rivaroxaban 2.5 Mg Oral Tablet', 'type': 'DRUG', 'otherNames': ['Xarelto'], 'description': 'Patients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months.', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'Colchicine 0.5 MG', 'type': 'DRUG', 'otherNames': ['Colchis'], 'description': 'Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.', 'armGroupLabels': ['Group 1', 'Group 3']}, {'name': 'Placebo Rivaroxaban', 'type': 'DRUG', 'description': 'Patients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months.', 'armGroupLabels': ['Group 3', 'Group 4']}, {'name': 'Placebo Colchicine', 'type': 'DRUG', 'description': 'Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.', 'armGroupLabels': ['Group 2', 'Group 4']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Remo Furtado, MD, PhD', 'role': 'CONTACT', 'email': 'remo.furtado@bcri.org.br', 'phone': '55 11 59047339'}], 'overallOfficials': [{'name': 'Renato D Lopes, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Brazilian Clinical Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brazilian Clinical Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alliança Diagnostic', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}