Clinical trial NCT03874338: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neutrophils.Hypersegmented &#X7C; Bld-Ser-Plas
STEMI - ST Elevation Myocardial Infarction
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Population Health Research Institute
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-03-14
Enrollment: 322
Sex: ALL
Minimum age (years): 19
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: soluble L-selectin
timeFrame: between baseline and 3 months
Secondary outcomes:
measure: Other soluble markers of neutrophil activity
timeFrame: between baseline and 3 months
measure: Markers of systemic inflammation
timeFrame: between baseline and 3 months
measure: Neutrophil-driven responses that may further propagate injury
timeFrame: between baseline and 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Binita Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: