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CLEAR SYNERGY Neutrophil Substudy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03874338
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : June 30, 2021
Sponsor:
Collaborators:
Population Health Research Institute
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Binita Shah, NYU Langone Health

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.

Condition or disease Intervention/treatment
Neutrophils.Hypersegmented | Bld-Ser-Plas STEMI - ST Elevation Myocardial Infarction Drug: Colchicine Pill

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Study Type : Observational
Estimated Enrollment : 670 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Studies on the Effects of Colchicine on Neutrophil Biology in Acute Myocardial Infarction: A Substudy of the CLEAR SYNERGY (OASIS 9) Trial
Actual Study Start Date : March 4, 2019
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Colchicine

Group/Cohort Intervention/treatment
Colchicine 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.

Placebo 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874338


Contacts
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Contact: Fatmira Curovic 646-501-9648 fatmira.curovic@nyumc.org
Contact: Binita Shah, MD

Locations
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United States, New York
NYU School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Fatmira Curovic    646-501-9648    fatmira.curovic@nyumc.org   
Contact: Binita Shah, MD         
Sponsors and Collaborators
NYU Langone Health
Population Health Research Institute
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Binita Shah, MD NYU School of Medicine
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Responsible Party: Binita Shah, Assistant Professor of Medicine, NYU Langone Health
ClinicalTrials.gov Identifier: NCT03874338    
Other Study ID Numbers: 18-01323
1R01HL146206 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents