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| 1 | +<?xml version="1.0" encoding="UTF-8"?> |
| 2 | +<clinical_study> |
| 3 | + <!-- This xml conforms to an XML Schema at: |
| 4 | + https://clinicaltrials.gov/ct2/html/images/info/public.xsd --> |
| 5 | + <required_header> |
| 6 | + <download_date>ClinicalTrials.gov processed this data on July 19, 2020</download_date> |
| 7 | + <link_text>Link to the current ClinicalTrials.gov record.</link_text> |
| 8 | + <url>https://clinicaltrials.gov/show/NCT03874338</url> |
| 9 | + </required_header> |
| 10 | + <id_info> |
| 11 | + <org_study_id>18-01323</org_study_id> |
| 12 | + <secondary_id>1R01HL146206</secondary_id> |
| 13 | + <nct_id>NCT03874338</nct_id> |
| 14 | + </id_info> |
| 15 | + <brief_title>CLEAR SYNERGY Neutrophil Substudy</brief_title> |
| 16 | + <official_title>Studies on the Effects of Colchicine on Neutrophil Biology in Acute Myocardial Infarction: A Substudy of the CLEAR SYNERGY (OASIS 9) Trial</official_title> |
| 17 | + <sponsors> |
| 18 | + <lead_sponsor> |
| 19 | + <agency>NYU Langone Health</agency> |
| 20 | + <agency_class>Other</agency_class> |
| 21 | + </lead_sponsor> |
| 22 | + <collaborator> |
| 23 | + <agency>Population Health Research Institute</agency> |
| 24 | + <agency_class>Other</agency_class> |
| 25 | + </collaborator> |
| 26 | + <collaborator> |
| 27 | + <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency> |
| 28 | + <agency_class>NIH</agency_class> |
| 29 | + </collaborator> |
| 30 | + </sponsors> |
| 31 | + <source>NYU Langone Health</source> |
| 32 | + <oversight_info> |
| 33 | + <has_dmc>No</has_dmc> |
| 34 | + <is_fda_regulated_drug>No</is_fda_regulated_drug> |
| 35 | + <is_fda_regulated_device>No</is_fda_regulated_device> |
| 36 | + </oversight_info> |
| 37 | + <brief_summary> |
| 38 | + <textblock> |
| 39 | + CLEAR SYNERGY is an international multi center 2x2 randomized placebo controlled trial of |
| 40 | + </textblock> |
| 41 | + </brief_summary> |
| 42 | + <overall_status>Recruiting</overall_status> |
| 43 | + <start_date type="Actual">March 4, 2019</start_date> |
| 44 | + <completion_date type="Anticipated">February 1, 2022</completion_date> |
| 45 | + <primary_completion_date type="Anticipated">February 1, 2021</primary_completion_date> |
| 46 | + <study_type>Observational</study_type> |
| 47 | + <has_expanded_access>No</has_expanded_access> |
| 48 | + <study_design_info> |
| 49 | + <observational_model>Other</observational_model> |
| 50 | + <time_perspective>Prospective</time_perspective> |
| 51 | + </study_design_info> |
| 52 | + <primary_outcome> |
| 53 | + <measure>soluble L-selectin</measure> |
| 54 | + <time_frame>between baseline and 3 months</time_frame> |
| 55 | + <description>Change in soluble L-selectin between baseline and 3 mo after STEMI in the placebo vs. colchicine groups.</description> |
| 56 | + </primary_outcome> |
| 57 | + <secondary_outcome> |
| 58 | + <measure>Other soluble markers of neutrophil activity</measure> |
| 59 | + <time_frame>between baseline and 3 months</time_frame> |
| 60 | + <description>Other 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)</description> |
| 61 | + </secondary_outcome> |
| 62 | + <secondary_outcome> |
| 63 | + <measure>Markers of systemic inflammation</measure> |
| 64 | + <time_frame>between baseline and 3 months</time_frame> |
| 65 | + <description>Markers of systemic inflammation will be evaluated at baseline and 3 months after STEMI (high sensitive CRP, IL-1β)</description> |
| 66 | + </secondary_outcome> |
| 67 | + <secondary_outcome> |
| 68 | + <measure>Neutrophil-driven responses that may further propagate injury</measure> |
| 69 | + <time_frame>between baseline and 3 months</time_frame> |
| 70 | + <description>Neutrophil-driven responses that may further propagate injury will be evaluated at baseline and 3 months after STEMI (neutrophil extracellular traps, neutrophil-derived microparticles)</description> |
| 71 | + </secondary_outcome> |
| 72 | + <number_of_groups>2</number_of_groups> |
| 73 | + <enrollment type="Anticipated">670</enrollment> |
| 74 | + <condition>Neutrophils.Hypersegmented ; Bld-Ser-Plas</condition> |
| 75 | + <condition>STEMI - ST Elevation Myocardial Infarction</condition> |
| 76 | + <arm_group> |
| 77 | + <arm_group_label>Colchicine</arm_group_label> |
| 78 | + </arm_group> |
| 79 | + <arm_group> |
| 80 | + <arm_group_label>Placebo</arm_group_label> |
| 81 | + </arm_group> |
| 82 | + <intervention> |
| 83 | + <intervention_type>Drug</intervention_type> |
| 84 | + <intervention_name>Colchicine Pill</intervention_name> |
| 85 | + <description>Participants 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.</description> |
| 86 | + <arm_group_label>Colchicine</arm_group_label> |
| 87 | + <arm_group_label>Placebo</arm_group_label> |
| 88 | + </intervention> |
| 89 | + <eligibility> |
| 90 | + <study_pop> |
| 91 | + <textblock> |
| 92 | + Patients who are randomized to the drug RCT portion of the CLEAR SYNERGY (OASIS 9) trial |
| 93 | + </textblock> |
| 94 | + </study_pop> |
| 95 | + <sampling_method>Non-Probability Sample</sampling_method> |
| 96 | + <criteria> |
| 97 | + <textblock> |
| 98 | + Inclusion Criteria: |
| 99 | + </textblock> |
| 100 | + </criteria> |
| 101 | + <gender>All</gender> |
| 102 | + <minimum_age>19 Years</minimum_age> |
| 103 | + <maximum_age>110 Years</maximum_age> |
| 104 | + <healthy_volunteers>No</healthy_volunteers> |
| 105 | + </eligibility> |
| 106 | + <overall_official> |
| 107 | + <last_name>Binita Shah, MD</last_name> |
| 108 | + <role>Principal Investigator</role> |
| 109 | + <affiliation>NYU School of Medicine</affiliation> |
| 110 | + </overall_official> |
| 111 | + <overall_contact> |
| 112 | + <last_name>Fatmira Curovic</last_name> |
| 113 | + <phone>646-501-9648</phone> |
| 114 | + |
| 115 | + </overall_contact> |
| 116 | + <overall_contact_backup> |
| 117 | + <last_name>Binita Shah, MD</last_name> |
| 118 | + </overall_contact_backup> |
| 119 | + <location> |
| 120 | + <facility> |
| 121 | + <name>NYU School of Medicine</name> |
| 122 | + <address> |
| 123 | + <city>New York</city> |
| 124 | + <state>New York</state> |
| 125 | + <zip>10016</zip> |
| 126 | + <country>United States</country> |
| 127 | + </address> |
| 128 | + </facility> |
| 129 | + <status>Recruiting</status> |
| 130 | + <contact> |
| 131 | + <last_name>Fatmira Curovic</last_name> |
| 132 | + <phone>646-501-9648</phone> |
| 133 | + |
| 134 | + </contact> |
| 135 | + <contact_backup> |
| 136 | + <last_name>Binita Shah, MD</last_name> |
| 137 | + </contact_backup> |
| 138 | + </location> |
| 139 | + <location_countries> |
| 140 | + <country>United States</country> |
| 141 | + </location_countries> |
| 142 | + <verification_date>September 2019</verification_date> |
| 143 | + <study_first_submitted>March 12, 2019</study_first_submitted> |
| 144 | + <study_first_submitted_qc>March 12, 2019</study_first_submitted_qc> |
| 145 | + <study_first_posted type="Actual">March 14, 2019</study_first_posted> |
| 146 | + <last_update_submitted>September 10, 2019</last_update_submitted> |
| 147 | + <last_update_submitted_qc>September 10, 2019</last_update_submitted_qc> |
| 148 | + <last_update_posted type="Actual">September 12, 2019</last_update_posted> |
| 149 | + <responsible_party> |
| 150 | + <responsible_party_type>Principal Investigator</responsible_party_type> |
| 151 | + <investigator_affiliation>NYU Langone Health</investigator_affiliation> |
| 152 | + <investigator_full_name>Binita Shah</investigator_full_name> |
| 153 | + <investigator_title>Assistant Professor of Medicine</investigator_title> |
| 154 | + </responsible_party> |
| 155 | + <condition_browse> |
| 156 | + <!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm --> |
| 157 | + <mesh_term>Myocardial Infarction</mesh_term> |
| 158 | + <mesh_term>ST Elevation Myocardial Infarction</mesh_term> |
| 159 | + <mesh_term>Infarction</mesh_term> |
| 160 | + </condition_browse> |
| 161 | + <intervention_browse> |
| 162 | + <!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm --> |
| 163 | + <mesh_term>Colchicine</mesh_term> |
| 164 | + </intervention_browse> |
| 165 | + <patient_data> |
| 166 | + <sharing_ipd>No</sharing_ipd> |
| 167 | + </patient_data> |
| 168 | + <!-- Results have not yet been posted for this study --> |
| 169 | +</clinical_study> |
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