Neutrophils.Hypersegmented | Bld-Ser-PlasNCT03874338
CLEAR SYNERGY Neutrophil Substudy
An observational study of Neutrophils.Hypersegmented | Bld-Ser-Plas and STEMI - ST Elevation Myocardial Infarction, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 110 years
- Conditions the study is for
- Neutrophils.Hypersegmented | Bld-Ser-Plas, STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- Colchicine Pill
- Type of treatment
- Pill or oral medicine
- How many people
- 322 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2019to 9 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Use of anti-inflammatory agents (except aspirin)
- Active infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Studies on the Effects of Colchicine on Neutrophil Biology in Acute Myocardial Infarction: A Substudy of the CLEAR SYNERGY (OASIS 9) Trial
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:
- Evaluation of markers of neutrophil activity at randomization (baseline) and 3 months follow-up in the colchicine versus placebo groups, and;
- Examination of clinical and genetic factors that determine heterogeneity of treatment response and distinguish colchicine responders from non- responders.
Read more
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:
- Assess the effect of colchicine on neutrophil activation in response to STEMI.
- Examine clinical and genetic factors that determine heterogeneity of treatment response anddistinguish colchicine responders from non- responders.
- 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
- Being tested
- Colchicine Pill
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine PillDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Not described Receives: Drug: Colchicine Pill | |
| Placebo | Not described Receives: Drug: Colchicine Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
soluble L-selectin
Change in soluble L-selectin between baseline and 3 mo after STEMI in the placebo vs. colchicine groups.
Measured: between baseline and 3 months
Secondary outcomes (3)
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)
Measured: between baseline and 3 months
Markers of systemic inflammation
Markers of systemic inflammation will be evaluated at baseline and 3 months after STEMI (high sensitive CRP, IL-1β)
Measured: between baseline and 3 months
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)
Measured: between baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start4 Mar 2019
- Primary completion20 Feb 2023
- Study completion9 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neutrophils.Hypersegmented | Bld-Ser-PlasStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Research Institute, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Binita Shah, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874338
- Sponsor's protocol ID
- 18-01323
- Other IDs
- 1R01HL146206
- Status last verified
- Sep 2024
- First submitted
- 12 Mar 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies on the Effects of Colchicine on Neutrophil Biology in Acute Myocardial Infarction: A Substudy of the CLEAR SYNERGY (OASIS 9) Trial
- ClinicalTrials.gov ID
- NCT03874338
- Acronym / sponsor ID
- 18-01323
- Conditions
- Neutrophils.Hypersegmented | Bld-Ser-Plas, STEMI - ST Elevation Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Population Health Research Institute, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 9 Aug 2024 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluation of markers of neutrophil activity at randomization (baseline) and 3 months follow-up in the colchicine versus placebo groups, and;
- 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:
- Assess the effect of colchicine on neutrophil activation in response to STEMI.
- Examine clinical and genetic factors that determine heterogeneity of treatment response anddistinguish colchicine responders from non- responders.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | – | Drug: Colchicine Pill |
| Placebo | – | Drug: Colchicine Pill |
Who may qualify
- Ages
- 19 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Use of anti-inflammatory agents (except aspirin)
- Active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine PillParticipants 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. | Drug | Colchicine, Placebo |
Primary outcome
soluble L-selectin
Time frame: between baseline and 3 months
Change in soluble L-selectin between baseline and 3 mo after STEMI in the placebo vs. colchicine groups.
3 secondary outcomes
Other soluble markers of neutrophil activity
Time frame: between baseline and 3 months
Markers of systemic inflammation
Time frame: between baseline and 3 months
Neutrophil-driven responses that may further propagate injury
Time frame: between baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Binita Shah, MD principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neutrophils.Hypersegmented | Bld-Ser-Plas and STEMI - ST Elevation Myocardial Infarction, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
soluble L-selectin (time frame: between baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.