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Completed

NCT Number: NCT03874338

CLEAR SYNERGY Neutrophil Substudy

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.

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Key information

Conditions

Neutrophils.Hypersegmented | Bld-Ser-Plas Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction STEMI - ST Elevation Myocardial Infarction Vascular Diseases

Age range

19 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colchicine Pill

Drug

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Population Health Research Institute

Registry information

Official study title

Studies on the Effects of Colchicine on Neutrophil Biology in Acute Myocardial Infarction: A Substudy of the CLEAR SYNERGY (OASIS 9) Trial

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Mar 14, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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