{"id":"acenocoumarol","rwe":[{"pmid":"41898440","year":"2026","title":"Anticoagulation Therapy in Advanced Chronic Kidney Disease: Balancing Bleeding and Thromboembolic Risk.","finding":"","journal":"International journal of molecular sciences","studyType":"Clinical Study"},{"pmid":"41848355","year":"2026","title":"Treatment Stability of Warfarin and Acenocoumarol in Patients With Mechanical Heart Valves and Atrial Fibrillation: A One-Year Cohort Study.","finding":"","journal":"Acta medica academica","studyType":"Clinical Study"},{"pmid":"41769667","year":"2025","title":"Acute STEMI in a Young Adult on Therapeutic Anticoagulation Following Diclofenac Use.","finding":"","journal":"Journal of the Saudi Heart Association","studyType":"Clinical Study"},{"pmid":"41660507","year":"2026","title":"Addressing genetic diversity and health inequities: RELIVAF's proposal for Latin American pharmacogenomic guidelines.","finding":"","journal":"Frontiers in pharmacology","studyType":"Clinical Study"},{"pmid":"41654428","year":"2026","title":"Argatroban Anticoagulation for Heparin Induced Thrombocytopenia After Heartmate 3 Implantation: A Case Series.","finding":"","journal":"Transplantation proceedings","studyType":"Clinical Study"}],"tags":[{"label":"acenocoumarol","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Vitamin K epoxide reductase complex subunit 1","category":"target"},{"label":"VKORC1","category":"gene"},{"label":"B01AA07","category":"atc"},{"label":"Active","category":"status"},{"label":"Pulmonary embolism","category":"indication"},{"label":"Venous thrombosis","category":"indication"},{"label":"Anticoagulants","category":"pharmacology"},{"label":"Hematologic Agents","category":"pharmacology"}],"phase":"phase_3","safety":{"safetySignals":[{"llr":1201.404,"date":"","count":807,"signal":"Drug interaction","source":"DrugCentral FAERS","actionTaken":"Reported 807 times (LLR=1201)"},{"llr":580.876,"date":"","count":288,"signal":"International normalised ratio increased","source":"DrugCentral FAERS","actionTaken":"Reported 288 times (LLR=581)"},{"llr":531.625,"date":"","count":112,"signal":"Hypocoagulable state","source":"DrugCentral FAERS","actionTaken":"Reported 112 times (LLR=532)"},{"llr":243.715,"date":"","count":215,"signal":"Cardiac failure","source":"DrugCentral FAERS","actionTaken":"Reported 215 times (LLR=244)"},{"llr":241.338,"date":"","count":113,"signal":"Haemorrhage intracranial","source":"DrugCentral FAERS","actionTaken":"Reported 113 times (LLR=241)"},{"llr":165.828,"date":"","count":98,"signal":"Upper gastrointestinal haemorrhage","source":"DrugCentral FAERS","actionTaken":"Reported 98 times (LLR=166)"},{"llr":145.097,"date":"","count":101,"signal":"Haematoma","source":"DrugCentral FAERS","actionTaken":"Reported 101 times (LLR=145)"},{"llr":141.01,"date":"","count":46,"signal":"Abdominal wall haematoma","source":"DrugCentral FAERS","actionTaken":"Reported 46 times (LLR=141)"},{"llr":129.15,"date":"","count":287,"signal":"Acute kidney injury","source":"DrugCentral FAERS","actionTaken":"Reported 287 times (LLR=129)"},{"llr":124.855,"date":"","count":75,"signal":"Subdural haematoma","source":"DrugCentral FAERS","actionTaken":"Reported 75 times (LLR=125)"},{"llr":120.469,"date":"","count":266,"signal":"Anaemia","source":"DrugCentral FAERS","actionTaken":"Reported 266 times (LLR=120)"},{"llr":114.891,"date":"","count":41,"signal":"Retroperitoneal haematoma","source":"DrugCentral FAERS","actionTaken":"Reported 41 times (LLR=115)"},{"llr":107.726,"date":"","count":57,"signal":"Torsade de pointes","source":"DrugCentral FAERS","actionTaken":"Reported 57 times (LLR=108)"},{"llr":107.259,"date":"","count":41,"signal":"Muscle haemorrhage","source":"DrugCentral FAERS","actionTaken":"Reported 41 times (LLR=107)"},{"llr":97.197,"date":"","count":50,"signal":"Lower gastrointestinal haemorrhage","source":"DrugCentral FAERS","actionTaken":"Reported 50 times (LLR=97)"}],"commonSideEffects":[{"effect":"Drug interaction","drugRate":"LLR 1201","severity":"serious"},{"effect":"International normalised ratio increased","drugRate":"LLR 581","severity":"serious"},{"effect":"Hypocoagulable state","drugRate":"LLR 532","severity":"serious"},{"effect":"Cardiac failure","drugRate":"LLR 244","severity":"common"},{"effect":"Haemorrhage intracranial","drugRate":"LLR 241","severity":"common"},{"effect":"Upper gastrointestinal haemorrhage","drugRate":"LLR 166","severity":"common"},{"effect":"Haematoma","drugRate":"LLR 145","severity":"common"},{"effect":"Abdominal wall haematoma","drugRate":"LLR 141","severity":"common"},{"effect":"Acute kidney injury","drugRate":"LLR 129","severity":"common"},{"effect":"Subdural haematoma","drugRate":"LLR 125","severity":"common"},{"effect":"Anaemia","drugRate":"LLR 120","severity":"common"},{"effect":"Retroperitoneal haematoma","drugRate":"LLR 115","severity":"common"},{"effect":"Torsade de pointes","drugRate":"LLR 108","severity":"common"},{"effect":"Muscle haemorrhage","drugRate":"LLR 107","severity":"common"},{"effect":"Lower gastrointestinal haemorrhage","drugRate":"LLR 97","severity":"common"}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"sintrom","offLabel":[],"synonyms":["G 23350","G-23350","sintrom","acenocoumarin","nicoumalone","acenocoumarol"],"timeline":[],"brandName":"Sintrom","ecosystem":[{"indication":"Pulmonary embolism","otherDrugs":[{"name":"alteplase","slug":"alteplase","company":"Genentech"},{"name":"bemiparin","slug":"bemiparin","company":"Pfizer Inc"},{"name":"dabigatran etexilate","slug":"dabigatran-etexilate","company":"Boehringer Ingelheim"},{"name":"edoxaban","slug":"edoxaban","company":"Daiichi Sankyo"}],"globalPrevalence":null},{"indication":"Venous thrombosis","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"target":"Vitamin K epoxide reductase complex subunit 1","targets":[{"gene":"VKORC1","source":"DrugCentral","target":"Vitamin K epoxide reductase complex subunit 1","protein":"Vitamin K epoxide reductase complex subunit 1"}],"modality":"Small Molecule","drugClass":"acenocoumarol","explanation":"Think of your blood as a liquid that can clot to stop bleeding when you're injured. Clotting factors are like special proteins that help your blood turn into a solid to stop the bleeding. Acenocoumarol stops the liver from making these clotting factors, which helps prevent blood clots from forming in the first place.","oneSentence":"Acenocoumarol works by blocking the enzyme that helps produce clotting factors in the liver.","technicalDetail":"Acenocoumarol is a competitive inhibitor of vitamin K epoxide reductase complex subunit 1 (VKORC1), which is essential for the recycling of vitamin K in the liver. By inhibiting VKORC1, acenocoumarol reduces the production of vitamin K-dependent clotting factors, including prothrombin and factors II, VII, IX, and X."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Acenocoumarol","title":"Acenocoumarol","extract":"Acenocoumarol is an anticoagulant that functions as a vitamin K antagonist. It is a derivative of coumarin and is generic, so is marketed under many brand names worldwide."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/48","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ACENOCOUMAROL","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ACENOCOUMAROL","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Acenocoumarol","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T08:22:22.452636","biosimilars":[],"competitors":[{"drugName":"dicoumarol","drugSlug":"dicoumarol","fdaApproval":"1944-07-31","relationship":"same-class"},{"drugName":"phenindione","drugSlug":"phenindione","fdaApproval":"","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"warfarin","drugSlug":"warfarin","fdaApproval":"1954-06-08","genericCount":12,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"phenprocoumon","drugSlug":"phenprocoumon","fdaApproval":"1957-12-30","patentStatus":"Unknown","relationship":"same-class"}],"genericName":"acenocoumarol","indications":{"approved":[{"name":"Pulmonary embolism","source":"DrugCentral","snomedId":59282003,"regulator":"FDA"},{"name":"Venous thrombosis","source":"DrugCentral","snomedId":111293003,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"dicoumarol","brandName":"dicoumarol","genericName":"dicoumarol","approvalYear":"1944","relationship":"same-class"},{"drugId":"phenindione","brandName":"phenindione","genericName":"phenindione","approvalYear":"","relationship":"same-class"},{"drugId":"warfarin","brandName":"warfarin","genericName":"warfarin","approvalYear":"1954","relationship":"same-class"},{"drugId":"phenprocoumon","brandName":"phenprocoumon","genericName":"phenprocoumon","approvalYear":"1957","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT05825573","phase":"PHASE3","title":"Anticoagulation Therapy in Non-device-related Intra-cardiac Thrombus","status":"ACTIVE_NOT_RECRUITING","sponsor":"Centre Hospitalier Universitaire de Nīmes","startDate":"2023-05-15","conditions":["Intracardiac Thrombus","STEMI","Heart Failure"],"enrollment":340,"completionDate":"2026-02"},{"nctId":"NCT05646394","phase":"","title":"Registry on Augmented Antithrombotic Treatment Regimens for Patients With Arterial Thrombotic APS","status":"RECRUITING","sponsor":"McMaster University","startDate":"2022-07-01","conditions":["Antiphospholipid Syndrome","Arterial Thrombosis"],"enrollment":150,"completionDate":"2029-12-31"},{"nctId":"NCT02800941","phase":"","title":"Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Saint Etienne","startDate":"2017-07-05","conditions":["Pulmonary Arterial Hypertension"],"enrollment":203,"completionDate":"2023-09-05"},{"nctId":"NCT04437303","phase":"PHASE4","title":"Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)","status":"COMPLETED","sponsor":"St. Antonius Hospital","startDate":"2020-11-25","conditions":["Aortic Valve Disease","Aortic Valve Stenosis","Stroke","Bleeding","Vascular Complications","Myocardial Infarction","Thrombosis Embolism"],"enrollment":858,"completionDate":"2024-05-22"},{"nctId":"NCT02046460","phase":"PHASE3","title":"Biomarkers and Antithrombotic Treatment in Cervical Artery Dissection - TREAT-CAD","status":"COMPLETED","sponsor":"Stefan Engelter","startDate":"2013-09","conditions":["Cervical Artery Dissection"],"enrollment":194,"completionDate":"2019-06"},{"nctId":"NCT01556659","phase":"NA","title":"LV Thrombus After Acute AMI: A Randomized Controlled Trial","status":"TERMINATED","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","startDate":"2012-03","conditions":["Ventricular Thrombosis Mural Following Myocardial Infarction"],"enrollment":25,"completionDate":"2022-06"},{"nctId":"NCT00742859","phase":"PHASE2","title":"Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin","status":"COMPLETED","sponsor":"Portola Pharmaceuticals","startDate":"2008-10","conditions":["Atrial Fibrillation"],"enrollment":508,"completionDate":"2009-11"},{"nctId":"NCT05515120","phase":"PHASE2,PHASE3","title":"Rivaroxaban Plus Aspirin to Manage Recurrent Venous Thromboembolic Events","status":"COMPLETED","sponsor":"Instituto Mexicano del Seguro Social","startDate":"2021-01-03","conditions":["Venous Thromboembolism","Anticoagulant-induced Bleeding","Venous Thromboses","Pulmonary Embolism"],"enrollment":58,"completionDate":"2022-07-01"},{"nctId":"NCT03153150","phase":"PHASE3","title":"Start or STop Anticoagulants Randomised Trial (SoSTART)","status":"COMPLETED","sponsor":"University of Edinburgh","startDate":"2018-03-28","conditions":["Intracranial Hemorrhages","Intracranial Hemorrhage, Hypertensive","Subarachnoid Hemorrhage","Subdural Hematoma","Intraventricular Hemorrhage","Atrial Fibrillation","Atrial Flutter","Small Vessel Cerebrovascular Disease","Microhaemorrhage"],"enrollment":203,"completionDate":"2021-03-26"},{"nctId":"NCT02286414","phase":"","title":"Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in Patients Aged 80 Years and Over","status":"COMPLETED","sponsor":"Assistance Publique - 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11","pmid":"41898440","title":"Anticoagulation Therapy in Advanced Chronic Kidney Disease: Balancing Bleeding and Thromboembolic Risk.","journal":"International journal of molecular sciences"},{"date":"2026 Mar 2","pmid":"41848355","title":"Treatment Stability of Warfarin and Acenocoumarol in Patients With Mechanical Heart Valves and Atrial Fibrillation: A One-Year Cohort Study.","journal":"Acta medica academica"},{"date":"2025","pmid":"41769667","title":"Acute STEMI in a Young Adult on Therapeutic Anticoagulation Following Diclofenac Use.","journal":"Journal of the Saudi Heart Association"},{"date":"2026","pmid":"41660507","title":"Addressing genetic diversity and health inequities: RELIVAF's proposal for Latin American pharmacogenomic guidelines.","journal":"Frontiers in pharmacology"},{"date":"2026 Mar","pmid":"41654428","title":"Argatroban Anticoagulation for Heparin Induced Thrombocytopenia After Heartmate 3 Implantation: A Case Series.","journal":"Transplantation proceedings"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Sintrom (Acenocoumarol) is a small molecule anticoagulant medication that targets Vitamin K epoxide reductase complex subunit 1. It works by inhibiting the production of vitamin K-dependent clotting factors, thereby preventing the formation of blood clots. Sintrom is approved to treat pulmonary embolism and venous thrombosis. The commercial status of Sintrom is unclear, but it is a generic version of a patented medication. Key safety considerations include the risk of bleeding and the need for regular monitoring of international normalized ratio (INR) levels.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}