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
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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:
- Evaluation of markers of neutrophil activity at randomization (baseline) and 3 months follow-up in the colchicine versus placebo groups, and;
- 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:
- Assess the effect of colchicine on neutrophil activation in response to STEMI.
- Examine clinical and genetic factors that determine heterogeneity of treatment response anddistinguish colchicine responders from non- responders.
- 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 |
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 |

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. |
- 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.
- 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)

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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 |
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

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
Contact: Fatmira Curovic | 347-602-2934 | fatmira.curovic@nyumc.org | |
Contact: Binita Shah, MD |
United States, New York | |
NYU School of Medicine | Recruiting |
New York, New York, United States, 10016 | |
Contact: Fatmira Curovic 347-602-2934 fatmira.curovic@nyumc.org | |
Contact: Binita Shah, MD |
Principal Investigator: | Binita Shah, MD | NYU School of Medicine |
Responsible Party: | 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: | May 5, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |