CLEAR SYNERGY Neutrophil Substudy

Active, not recruiting

• Conditions: STEMI - ST Elevation Myocardial Infarction; Neutrophils.Hypersegmented | Bld-Ser-Plas
• Interventions: Drug: Colchicine Pill

• Registration Number: NCT03874338
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-03-04
• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-14
• Primary Completion: 2023-02-20
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 322

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.

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Exclusion Criteria

• Use of anti-inflammatory agents (except aspirin)
• Active infection

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo	Colchicine Pill	-
Colchicine	Colchicine Pill	-

Primary Outcome Measures

Name	Time	Method
soluble L-selectin	between baseline and 3 months	Change in soluble L-selectin between baseline and 3 mo after STEMI in the placebo vs. colchicine groups.

Secondary Outcome Measures

Name	Time	Method
Markers of systemic inflammation	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	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)
Other soluble markers of neutrophil activity	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)

Trial Locations

Locations (1)

NYU School of Medicine; 🇺🇸 New York, New York, United States