CLEAR SYNERGY Neutrophil Substudy

STEMI - ST Elevation Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03874338
• Other study ID #: 18-01323
• Secondary ID: 1R01HL146206
• Status: Active, not recruiting
• Start date: March 4, 2019
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 322
• Est. completion date: July 1, 2024
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	NYU School of Medicine	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
NYU Langone Health	National Heart, Lung, and Blood Institute (NHLBI), Population Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	soluble L-selectin	Change in soluble L-selectin between baseline and 3 mo after STEMI in the placebo vs. colchicine groups.	between baseline and 3 months
Secondary	Other soluble markers of neutrophil activity	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)	between baseline and 3 months
Secondary	Markers of systemic inflammation	Markers of systemic inflammation will be evaluated at baseline and 3 months after STEMI (high sensitive CRP, IL-1ß)	between baseline and 3 months
Secondary	Neutrophil-driven responses that may further propagate injury	Neutrophil-driven responses that may further propagate injury will be evaluated at baseline and 3 months after STEMI (neutrophil extracellular traps, neutrophil-derived microparticles)	between baseline and 3 months