CLEAR SYNERGY Neutrophil Substudy

NYU Langone Health

Status: Completed

Conditions: Neutrophils.Hypersegmented | Bld-Ser-Plas; STEMI - ST Elevation Myocardial Infarction

Treatments: Drug: Colchicine Pill

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03874338

1R01HL146206 (U.S. NIH Grant/Contract)

18-01323

Details and patient eligibility

About

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.

Enrollment: 322 patients

Sex: All

Ages: 19 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

322 participants in 2 patient groups

Colchicine

Treatment:

Drug: Colchicine Pill

Placebo

Treatment:

Drug: Colchicine Pill