Other Clinical Trial - CLEAR SYNERGY Neutrophil Substudy

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Infarction
Myocardial Infarction
Neutrophils.Hypersegmented &#X7C; Bld-Ser-Plas
ST Elevation Myocardial Infarction
STEMI - ST Elevation Myocardial Infarction

Clinical Trial Details

NCT number	NCT03874338
Study type	Observational
Source	NYU Langone Health
Contact
Status	Active, not recruiting
Phase
Start date	March 4, 2019
Completion date	July 1, 2024

View Details

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