2023
Colchicine and high-intensity rosuvastatin in the treatment of non-critically ill patients hospitalised with COVID-19: a randomised clinical trial
Shah T, McCarthy M, Nasir I, Archer H, Ragheb E, Kluger J, Kashyap N, Paredes C, Patel P, Lu J, Kandel P, Song C, Khan M, Huang H, Haq F, Ahmad R, Howes C, Cambi B, Lancaster G, Cleman M, Dela Cruz C, Parise H, Lansky A. Colchicine and high-intensity rosuvastatin in the treatment of non-critically ill patients hospitalised with COVID-19: a randomised clinical trial. BMJ Open 2023, 13: e067910. PMID: 36828654, PMCID: PMC9971831, DOI: 10.1136/bmjopen-2022-067910.Peer-Reviewed Original ResearchConceptsStandard of careHigh-intensity rosuvastatinElectronic medical recordsCOVID-19 diseaseMedical recordsPrimary endpointThromboembolic eventsYale New Haven Health SystemSevere COVID-19 diseaseCOVID-19Prespecified primary endpointVenous thromboembolic eventsRisk of progressionCombination of colchicineSafety monitoring boardCare armHispanics/LatinosTherapeutic anticoagulationIndex hospitalisationIll patientsMedian ageFuture trialsEffect of colchicineClinical trialsMonitoring board
2021
Design and rationale of the colchicine/statin for the prevention of COVID-19 complications (COLSTAT) trial
Shah T, McCarthy M, Nasir I, Archer H, Ragheb E, Kluger J, Kashyap N, Paredes C, Patel P, Lu J, Kandel P, Song C, Khan M, Ul Haq F, Ahmad R, Howes C, Cambi B, Lancaster G, Cleman M, Dela Cruz CS, Parise H, Lansky A. Design and rationale of the colchicine/statin for the prevention of COVID-19 complications (COLSTAT) trial. Contemporary Clinical Trials 2021, 110: 106547. PMID: 34461322, PMCID: PMC8397504, DOI: 10.1016/j.cct.2021.106547.Peer-Reviewed Original ResearchConceptsHospitalized COVID-19 patientsCOVID-19 patientsStandard of careElectronic health recordsComplications TrialSevere COVID-19 diseaseWorld Health Organization (WHO) ordinal scaleVenous thromboembolic eventsHealth recordsCombination of colchicineRates of morbidityCOVID-19 diseaseCost-effective treatmentPrimary endpointRespiratory failureThromboembolic eventsClinical improvementMyocardial injuryPragmatic trialClinical trialsPatientsEvent ascertainmentHealth NetworkRosuvastatinTrialsImpact of colchicine on mortality in patients with COVID-19: A meta-analysis
Vrachatis DA, Giannopoulos GV, Giotaki SG, Raisakis K, Kossyvakis C, Iliodromitis KE, Reimers B, Tousoulis D, Cleman M, Stefanadis C, Lansky A, Deftereos SG. Impact of colchicine on mortality in patients with COVID-19: A meta-analysis. Hellenic Journal Of Cardiology 2021, 62: 374-377. PMID: 33421583, PMCID: PMC7833703, DOI: 10.1016/j.hjc.2020.11.012.Peer-Reviewed Original Research
2020
Immediate and long-term impact of the COVID-19 pandemic on cardiovascular clinical trials: considerations for study conduct and endpoint determination.
Lansky A, Shah T, Wijns W, Stefanini GG, Farb A, Kaplan A, Xu B, Pietras C, Velazquez E, Serruys PW, Mahfoud F, Baumbach A. Immediate and long-term impact of the COVID-19 pandemic on cardiovascular clinical trials: considerations for study conduct and endpoint determination. EuroIntervention 2020, 16: 787-793. PMID: 33215993, DOI: 10.4244/eijv16i10a147.Peer-Reviewed Original Research