{"id":"brinavess-vernakalant","safety":{"commonSideEffects":[{"rate":"10-15","effect":"Dysgeusia (taste disturbance)"},{"rate":"5-10","effect":"Flushing"},{"rate":"5-10","effect":"Phlebitis at infusion site"},{"rate":"5","effect":"Hypotension"},{"rate":"1-2","effect":"Ventricular arrhythmias"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Vernakalant is an atrial-selective antiarrhythmic agent that inhibits multiple ion channels (potassium and sodium channels) with preferential effects on atrial tissue. By blocking these channels, it prolongs the atrial action potential duration and refractory period, thereby suppressing ectopic atrial activity and facilitating conversion of atrial fibrillation to normal sinus rhythm. Its atrial selectivity reduces the risk of ventricular proarrhythmia compared to non-selective antiarrhythmics.","oneSentence":"Vernakalant blocks atrial-selective potassium and sodium channels to rapidly restore normal heart rhythm in patients with atrial fibrillation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:28:49.935Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Rapid conversion of recent-onset atrial fibrillation to sinus rhythm"}]},"trialDetails":[{"nctId":"NCT04485195","phase":"PHASE4","title":"RAFF4 Trial: Vernakalant vs. Procainamide for Acute Atrial Fibrillation in the Emergency Department","status":"COMPLETED","sponsor":"Ottawa Hospital Research Institute","startDate":"2021-06-17","conditions":"Atrial Fibrillation","enrollment":350},{"nctId":"NCT04748991","phase":"PHASE3","title":"Vernakalant Versus Amiodarone for Post-operative Atrial Fibrillation in Cardiac Surgery Patients","status":"NOT_YET_RECRUITING","sponsor":"University of Calgary","startDate":"2024-09","conditions":"Atrial Fibrillation, Post-cardiac Surgery","enrollment":50},{"nctId":"NCT03005366","phase":"PHASE4","title":"Predictive Factors to Effectively Terminate Paroxysmal Atrial Fibrillation by Blocking Atrial Selective Ionic Currents","status":"COMPLETED","sponsor":"David Filgueiras-Rama","startDate":"2017-01","conditions":"Paroxysmal Atrial Fibrillation","enrollment":50},{"nctId":"NCT01370629","phase":"","title":"Study of Normal Conditions of Use, Dosing, and Safety of Intravenous (IV) Administration of Vernakalant (MK-6621-049)","status":"COMPLETED","sponsor":"Correvio International Sarl","startDate":"2011-08","conditions":"Atrial Fibrillation","enrollment":2015},{"nctId":"NCT01174160","phase":"PHASE3","title":"A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM4)","status":"COMPLETED","sponsor":"Advanz Pharma","startDate":"2010-08","conditions":"Atrial Fibrillation","enrollment":123},{"nctId":"NCT01447862","phase":"PHASE4","title":"Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation","status":"COMPLETED","sponsor":"Medical University of Vienna","startDate":"2011-10","conditions":"Atrial Fibrillation","enrollment":101},{"nctId":"NCT00989001","phase":"PHASE3","title":"A Phase 3b Study of Vernakalant Injection in Patients With Recent Onset Symptomatic Atrial Fibrillation (AF)(MK-6621-045)","status":"TERMINATED","sponsor":"Advanz Pharma","startDate":"2009-10","conditions":"Atrial Fibrillation","enrollment":217},{"nctId":"NCT01627106","phase":"PHASE4","title":"A Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation (AF) (MK-6621-055)","status":"WITHDRAWN","sponsor":"Advanz Pharma","startDate":"2012-09","conditions":"Atrial Fibrillation","enrollment":""},{"nctId":"NCT01646281","phase":"PHASE4","title":"Vernakalant Versus Flecainide: Atrial Contractility","status":"UNKNOWN","sponsor":"Maastricht University Medical Center","startDate":"2012-08","conditions":"Atrial Fibrillation","enrollment":70},{"nctId":"NCT00668759","phase":"PHASE3","title":"A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation","status":"COMPLETED","sponsor":"Advanz Pharma","startDate":"2008-04","conditions":"Atrial Fibrillation","enrollment":254},{"nctId":"NCT00526136","phase":"PHASE2","title":"Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study","status":"COMPLETED","sponsor":"Advanz Pharma","startDate":"2007-03","conditions":"Atrial Fibrillation","enrollment":735},{"nctId":"NCT00267930","phase":"PHASE2","title":"Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter Recurrence","status":"COMPLETED","sponsor":"Advanz Pharma","startDate":"2005-12","conditions":"Atrial Fibrillation","enrollment":221},{"nctId":"NCT00281554","phase":"PHASE3","title":"Study of RSD1235 to Evaluate Safety in Patients With Atrial Fibrillation","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2005-10","conditions":"Atrial Fibrillation","enrollment":254},{"nctId":"NCT00476112","phase":"PHASE2, PHASE3","title":"A Phase II/III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter","status":"COMPLETED","sponsor":"Advanz Pharma","startDate":"2003-08","conditions":"Atrial Flutter","enrollment":60},{"nctId":"NCT00468767","phase":"PHASE3","title":"Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation","status":"COMPLETED","sponsor":"Advanz Pharma","startDate":"2003-08","conditions":"Atrial Fibrillation","enrollment":356},{"nctId":"NCT00115791","phase":"PHASE3","title":"Study to Determine the Response and Effectiveness of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2004-06","conditions":"Atrial Flutter, Atrial Fibrillation","enrollment":276},{"nctId":"NCT00125320","phase":"PHASE3","title":"Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2004-06","conditions":"Atrial Fibrillation, Atrial Flutter","enrollment":190}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Brinavess (Vernakalant)","genericName":"Brinavess (Vernakalant)","companyName":"Medical University of Vienna","companyId":"medical-university-of-vienna","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Vernakalant blocks atrial-selective potassium and sodium channels to rapidly restore normal heart rhythm in patients with atrial fibrillation. Used for Rapid conversion of recent-onset atrial fibrillation to sinus rhythm.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}