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CLEAR SYNERGY Neutrophil Substudy

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ClinicalTrials.gov Identifier: NCT03874338
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : May 5, 2022
Sponsor:
Collaborators:
Population Health Research Institute
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date March 12, 2019
First Posted Date March 14, 2019
Last Update Posted Date May 5, 2022
Actual Study Start Date March 4, 2019
Estimated Primary Completion Date February 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 15, 2019)		 soluble L-selectin [ Time Frame: between baseline and 3 months ]
Change in soluble L-selectin between baseline and 3 mo after STEMI in the placebo vs. colchicine groups.
Original Primary Outcome Measures
 (submitted: March 12, 2019)		 Change in soluble L-selectin between baseline and 3 mo after STEMI in the placebo vs. colchicine groups. [ Time Frame: 3 months ]
Change History
Current Secondary Outcome Measures
 (submitted: March 15, 2019)
  • Other soluble markers of neutrophil activity [ Time Frame: between baseline and 3 months ]
    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)
  • Markers of systemic inflammation [ Time Frame: between baseline and 3 months ]
    Markers 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 injury [ Time Frame: between baseline and 3 months ]
    Neutrophil-driven responses that may further propagate injury will be evaluated at baseline and 3 months after STEMI (neutrophil extracellular traps, neutrophil-derived microparticles)
Original Secondary Outcome Measures
 (submitted: March 12, 2019)		 Other markers of neutrophil activity will be evaluated at baseline and 3 months after STEMI [ Time Frame: 3 months ]
E.g., myeloperoxidase, matrix metalloproteinase-9, neutrophil gelatinase-associated lipocalin, neutrophil elastase, intercellular/vascular cellular adhesion molecules, markers of systemic inflammation (high sensitive CRP, IL-1β), and neutrophil-driven responses that may further propagate injury (neutrophil extracellular traps, neutrophil-derived microparticles, endogenous thrombin potential)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CLEAR SYNERGY Neutrophil Substudy
Official Title Studies on the Effects of Colchicine on Neutrophil Biology in Acute Myocardial Infarction: A Substudy of the CLEAR SYNERGY (OASIS 9) Trial
Brief Summary

CLEAR SYNERGY is an international multi center 2x2 randomized placebo controlled trial of colchicine and spironolactone in patients with STEMI. Subjects enrolled in the main CLEAR SYNERGY trial will be asked to participate in this sub study (n=670) to undergo:

  1. Evaluation of markers of neutrophil activity at randomization (baseline) and 3 months follow-up in the colchicine versus placebo groups, and;
  2. Examination of clinical and genetic factors that determine heterogeneity of treatment response and distinguish colchicine responders from non- responders.

Participants undergo a blood draw at baseline and 3 months follow-up as part of the main trial, and participants who also participate in this sub study will have an additional 2 tablespoons of blood drawn.

The sub study objectives are to:

  1. Assess the effect of colchicine on neutrophil activation in response to STEMI.
  2. Examine clinical and genetic factors that determine heterogeneity of treatment response anddistinguish colchicine responders from non- responders.
  3. Explore the derivation of a risk score that includes markers of neutrophil activity and is associated with adjudicated MACE over 3 years after STEMI, and assess the impact of colchicine on the relation between this risk score and MACE.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who are randomized to the drug RCT portion of the CLEAR SYNERGY (OASIS 9) trial will be eligible for participation in this Neutrophil biomarker substudy. These are patients who present with STEMI.
Condition
  • Neutrophils.Hypersegmented | Bld-Ser-Plas
  • STEMI - ST Elevation Myocardial Infarction
Intervention Drug: Colchicine Pill
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.
Study Groups/Cohorts
  • Colchicine
    Intervention: Drug: Colchicine Pill
  • Placebo
    Intervention: Drug: Colchicine Pill
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 12, 2019)		 670
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 1, 2024
Estimated Primary Completion Date February 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients who are randomized to the drug RCT portion of the CLEAR SYNERGY (OASIS 9) trial will be eligible for participation in this Neutrophil biomarker substudy.

Exclusion Criteria:

  • Use of anti-inflammatory agents (except aspirin)
  • Active infection
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years to 110 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Fatmira Curovic 347-602-2934 fatmira.curovic@nyumc.org
Contact: Binita Shah, MD
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03874338
Other Study ID Numbers 18-01323
1R01HL146206 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party NYU Langone Health
Study Sponsor NYU Langone Health
Collaborators
  • Population Health Research Institute
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Binita Shah, MD NYU School of Medicine
PRS Account NYU Langone Health
Verification Date May 2022