CLEAR SYNERGY Neutrophil Substudy

NCT03874338 | Completed

• 2 other identifiers: 18-013231R01HL146206
• Study Type: observational
• Target: 322
• Locations: 1 country
• Sites: 1

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. 1.Evaluation of markers of neutrophil activity at randomization (baseline) and 3 months follow-up in the colchicine versus placebo groups, and;
2. 2.Examination of clinical and genetic factors that determine heterogeneity of treatment response and distinguish colchicine responders from non- responders.
3. 3.Assess the effect of colchicine on neutrophil activation in response to STEMI.
4. 4.Examine clinical and genetic factors that determine heterogeneity of treatment response anddistinguish colchicine responders from non- responders.
5. 5.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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Other soluble markers of neutrophil activity

  between baseline and 3 months

• Markers of systemic inflammation

  between baseline and 3 months

• Neutrophil-driven responses that may further propagate injury

  between baseline and 3 months

Study Arms (2)

Colchicine

Drug: Colchicine Pill

Placebo

Drug: Colchicine Pill

Interventions

Colchicine Pill DRUG

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.

Colchicine; Placebo

Eligibility Criteria

• Age: 19 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. These are patients who present with STEMI.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead
• Population Health Research Institute: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Binita Shah, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 14, 2019
• Study Start: March 4, 2019
• Primary Completion: February 20, 2023
• Study Completion: August 9, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)