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170 lines
7.4 KiB
XML
170 lines
7.4 KiB
XML
<?xml version="1.0" encoding="UTF-8"?>
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<clinical_study>
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<!-- This xml conforms to an XML Schema at:
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https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
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<required_header>
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<download_date>ClinicalTrials.gov processed this data on July 19, 2020</download_date>
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<link_text>Link to the current ClinicalTrials.gov record.</link_text>
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<url>https://clinicaltrials.gov/show/NCT03874338</url>
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</required_header>
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<id_info>
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<org_study_id>18-01323</org_study_id>
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<secondary_id>1R01HL146206</secondary_id>
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<nct_id>NCT03874338</nct_id>
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</id_info>
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<brief_title>CLEAR SYNERGY Neutrophil Substudy</brief_title>
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<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>
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<sponsors>
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<lead_sponsor>
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<agency>NYU Langone Health</agency>
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<agency_class>Other</agency_class>
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</lead_sponsor>
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<collaborator>
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<agency>Population Health Research Institute</agency>
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<agency_class>Other</agency_class>
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</collaborator>
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<collaborator>
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<agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
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<agency_class>NIH</agency_class>
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</collaborator>
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</sponsors>
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<source>NYU Langone Health</source>
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<oversight_info>
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<has_dmc>No</has_dmc>
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<is_fda_regulated_drug>No</is_fda_regulated_drug>
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<is_fda_regulated_device>No</is_fda_regulated_device>
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</oversight_info>
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<brief_summary>
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<textblock>
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CLEAR SYNERGY is an international multi center 2x2 randomized placebo controlled trial of
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</textblock>
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</brief_summary>
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<overall_status>Recruiting</overall_status>
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<start_date type="Actual">March 4, 2019</start_date>
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<completion_date type="Anticipated">February 1, 2022</completion_date>
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<primary_completion_date type="Anticipated">February 1, 2021</primary_completion_date>
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<study_type>Observational</study_type>
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<has_expanded_access>No</has_expanded_access>
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<study_design_info>
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<observational_model>Other</observational_model>
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<time_perspective>Prospective</time_perspective>
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</study_design_info>
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<primary_outcome>
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<measure>soluble L-selectin</measure>
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<time_frame>between baseline and 3 months</time_frame>
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<description>Change in soluble L-selectin between baseline and 3 mo after STEMI in the placebo vs. colchicine groups.</description>
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</primary_outcome>
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<secondary_outcome>
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<measure>Other soluble markers of neutrophil activity</measure>
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<time_frame>between baseline and 3 months</time_frame>
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<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>
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</secondary_outcome>
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<secondary_outcome>
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<measure>Markers of systemic inflammation</measure>
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<time_frame>between baseline and 3 months</time_frame>
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<description>Markers of systemic inflammation will be evaluated at baseline and 3 months after STEMI (high sensitive CRP, IL-1β)</description>
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</secondary_outcome>
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<secondary_outcome>
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<measure>Neutrophil-driven responses that may further propagate injury</measure>
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<time_frame>between baseline and 3 months</time_frame>
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<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>
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</secondary_outcome>
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<number_of_groups>2</number_of_groups>
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<enrollment type="Anticipated">670</enrollment>
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<condition>Neutrophils.Hypersegmented | Bld-Ser-Plas</condition>
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<condition>STEMI - ST Elevation Myocardial Infarction</condition>
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<arm_group>
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<arm_group_label>Colchicine</arm_group_label>
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</arm_group>
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<arm_group>
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<arm_group_label>Placebo</arm_group_label>
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</arm_group>
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<intervention>
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<intervention_type>Drug</intervention_type>
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<intervention_name>Colchicine Pill</intervention_name>
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<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>
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<arm_group_label>Colchicine</arm_group_label>
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<arm_group_label>Placebo</arm_group_label>
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</intervention>
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<eligibility>
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<study_pop>
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<textblock>
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Patients who are randomized to the drug RCT portion of the CLEAR SYNERGY (OASIS 9) trial
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</textblock>
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</study_pop>
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<sampling_method>Non-Probability Sample</sampling_method>
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<criteria>
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<textblock>
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Inclusion Criteria:
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</textblock>
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</criteria>
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<gender>All</gender>
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<minimum_age>19 Years</minimum_age>
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<maximum_age>110 Years</maximum_age>
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<healthy_volunteers>No</healthy_volunteers>
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</eligibility>
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<overall_official>
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<last_name>Binita Shah, MD</last_name>
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<role>Principal Investigator</role>
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<affiliation>NYU School of Medicine</affiliation>
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</overall_official>
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<overall_contact>
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<last_name>Fatmira Curovic</last_name>
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<phone>646-501-9648</phone>
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<email>fatmira.curovic@nyumc.org</email>
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</overall_contact>
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<overall_contact_backup>
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<last_name>Binita Shah, MD</last_name>
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</overall_contact_backup>
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<location>
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<facility>
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<name>NYU School of Medicine</name>
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<address>
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<city>New York</city>
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<state>New York</state>
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<zip>10016</zip>
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<country>United States</country>
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</address>
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</facility>
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<status>Recruiting</status>
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<contact>
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<last_name>Fatmira Curovic</last_name>
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<phone>646-501-9648</phone>
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<email>fatmira.curovic@nyumc.org</email>
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</contact>
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<contact_backup>
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<last_name>Binita Shah, MD</last_name>
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</contact_backup>
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</location>
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<location_countries>
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<country>United States</country>
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</location_countries>
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<verification_date>September 2019</verification_date>
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<study_first_submitted>March 12, 2019</study_first_submitted>
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<study_first_submitted_qc>March 12, 2019</study_first_submitted_qc>
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<study_first_posted type="Actual">March 14, 2019</study_first_posted>
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<last_update_submitted>September 10, 2019</last_update_submitted>
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<last_update_submitted_qc>September 10, 2019</last_update_submitted_qc>
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<last_update_posted type="Actual">September 12, 2019</last_update_posted>
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<responsible_party>
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<responsible_party_type>Principal Investigator</responsible_party_type>
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<investigator_affiliation>NYU Langone Health</investigator_affiliation>
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<investigator_full_name>Binita Shah</investigator_full_name>
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<investigator_title>Assistant Professor of Medicine</investigator_title>
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</responsible_party>
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<condition_browse>
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<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
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<mesh_term>Myocardial Infarction</mesh_term>
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<mesh_term>ST Elevation Myocardial Infarction</mesh_term>
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<mesh_term>Infarction</mesh_term>
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</condition_browse>
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<intervention_browse>
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<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
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<mesh_term>Colchicine</mesh_term>
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</intervention_browse>
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<patient_data>
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<sharing_ipd>No</sharing_ipd>
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</patient_data>
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<!-- Results have not yet been posted for this study -->
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</clinical_study>
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