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NCT03874338 · ClinicalTrials.gov registry record

CLEAR SYNERGY Neutrophil Substudy

A clinical trial, sponsored by NYU Langone Health.

Completed
Registry status
322
Enrollment target

NCT03874338 is a clinical trial that has completed, run by NYU Langone Health. The registered enrollment target is 322 participants.

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The verdict

NCT03874338 has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
322 participants
Enrollment target

Study 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.

Interventions

  • DRUG Colchicine Pill

Trial Details

FieldValue
Enrollment Target 322 participants
Start Date 2019-03-04
Est. Completion 2024-08-09

Sponsor

NYU Langone Health

1,164 total trials

What the Registry Record Tells You About NCT03874338

The ClinicalTrials.gov registry entry for NCT03874338 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 322 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Colchicine Pill is the first listed.

NCT03874338 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03874338 about?

NCT03874338 is a clinical study titled "CLEAR SYNERGY Neutrophil Substudy". 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...

What is the current status of trial NCT03874338?

This trial is currently completed. The enrollment target is 322 participants. The study started on 2019-03-04. Estimated completion is 2024-08-09.

What interventions are being tested in trial NCT03874338?

The interventions under investigation include: Colchicine Pill (DRUG).

Who is sponsoring clinical trial NCT03874338?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.