NCT03874338

CLEAR SYNERGY Neutrophil Substudy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 322 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 19 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neutrophils.Hypersegmented | Bld-Ser-Plas
• STEMI - ST Elevation Myocardial Infarction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-03-04
• Primary completion: 2023-02-20
• Completion: 2024-08-09
• First posted: 2019-03-14
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States