ClinicalTrials.gov processed this data on July 19, 2020Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/show/NCT0387433818-013231R01HL146206NCT03874338CLEAR SYNERGY Neutrophil SubstudyStudies on the Effects of Colchicine on Neutrophil Biology in Acute Myocardial Infarction: A Substudy of the CLEAR SYNERGY (OASIS 9) TrialNYU Langone HealthOtherPopulation Health Research InstituteOtherNational Heart, Lung, and Blood Institute (NHLBI)NIHNYU Langone HealthNoNoNo
CLEAR SYNERGY is an international multi center 2x2 randomized placebo controlled trial of
RecruitingMarch 4, 2019February 1, 2022February 1, 2021ObservationalNoOtherProspectivesoluble L-selectinbetween baseline and 3 monthsChange in soluble L-selectin between baseline and 3 mo after STEMI in the placebo vs. colchicine groups.Other soluble markers of neutrophil activitybetween baseline and 3 monthsOther markers of neutrophil activity will be evaluated at baseline and 3 months after STEMI (myeloperoxidase, matrix metalloproteinase-9, neutrophil gelatinase-associated lipocalin, neutrophil elastase, intercellular/vascular cellular adhesion molecules)Markers of systemic inflammationbetween baseline and 3 monthsMarkers of systemic inflammation will be evaluated at baseline and 3 months after STEMI (high sensitive CRP, IL-1β)Neutrophil-driven responses that may further propagate injurybetween baseline and 3 monthsNeutrophil-driven responses that may further propagate injury will be evaluated at baseline and 3 months after STEMI (neutrophil extracellular traps, neutrophil-derived microparticles)2670Neutrophils.Hypersegmented | Bld-Ser-PlasSTEMI - ST Elevation Myocardial InfarctionColchicinePlaceboDrugColchicine PillParticipants in the main CLEAR SYNERGY trial are randomized to colchicine/spironolactone versus placebo in a 2x2 factorial design. The substudy is interested in the evaluation of biospecimens obtained from patients in the colchicine vs placebo group.ColchicinePlacebo
Patients who are randomized to the drug RCT portion of the CLEAR SYNERGY (OASIS 9) trial
Non-Probability Sample
Inclusion Criteria:
All19 Years110 YearsNoBinita Shah, MDPrincipal InvestigatorNYU School of MedicineFatmira Curovic646-501-9648fatmira.curovic@nyumc.orgBinita Shah, MDNYU School of MedicineNew YorkNew York10016United StatesRecruitingFatmira Curovic646-501-9648fatmira.curovic@nyumc.orgBinita Shah, MDUnited StatesSeptember 2019March 12, 2019March 12, 2019March 14, 2019September 10, 2019September 10, 2019September 12, 2019Principal InvestigatorNYU Langone HealthBinita ShahAssistant Professor of MedicineMyocardial InfarctionST Elevation Myocardial InfarctionInfarctionColchicineNo