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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: Completed study, sponsored by NYU Langone Health.
NCT03874338 is a clinical trial that has completed, run by NYU Langone Health. The registered enrollment target is 322 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in soluble L-selectin between baseline and 3 mo after STEMI in the placebo vs. colchicine groups.
Interventions
- DRUG Colchicine Pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 322 participants |
| Start Date | 2019-03-04 |
| Est. Completion | 2024-08-09 |
What the finished NCT03874338 record still lists
NCT03874338 is an observational study that tracks outcomes without assigning an intervention. The registered 322 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Colchicine Pill is the first listed.
NCT03874338 does not publish any study locations in the registry export this page uses.
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.
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