Myocardial InfarctionPhase 4NCT02995512
Mechanistic Effects of Colchicine in Patients With Myocardial Infarction
A Phase 4 study testing Colchicine 0.6 mg tablets in people with Myocardial Infarction, run by NYU Langone Health.
Trial summary
The aim of this study is to determine the immuno-modulatory mechanistic effects of colchicine in patients with myocardial infarction (MI). Investigators hypothesize that colchicine exerts its anti-inflammatory properties by switching the metabolism of neutrophils, thereby reducing the expression of adhesion molecules… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Colchicine 0.6 mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2017to 12 Sep 2018
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age for the healthy volunteer subset.
- 18 years of age and within 24 hours of an MI for the MI subset.
Who cannot join
- Subjects in all 3 groups will be excluded if they meet one of the following criteria
- history of myelodysplasia;
- Use of anti-inflammatory medications, with the exception of aspirin, within 5 half-lives;
- medications known to interact with colchicine;
- known creatinine clearance <30 cc/minute (severe kidney disease);
- pregnant; or
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- Unable to consent.
- MI subjects who will have oral colchicine administered will have the following additional exclusion criteria:
- history of intolerance to colchicine;
- acute or chronic symptoms of diarrhea within 72 hours prior to enrollment;
- hemoglobin <10 g/dL or clinical evidence of active bleeding during the study period.
About this study
Official title: Mechanistic Effects of Colchicine in Patients With Myocardial Infarction A Single Center Phase 4 Single Arm Open-label Study Evaluating the FDA-approved Drug, Colchicine, at the FDA-approved Gout Dose in Patients With Myocardial Infarction
The aim of this study is to determine the immuno-modulatory mechanistic effects of colchicine in patients with myocardial infarction (MI). Investigators hypothesize that colchicine exerts its anti-inflammatory properties by switching the metabolism of neutrophils, thereby reducing the expression of adhesion molecules responsible for their recruitment in MI.
Read the detailed description
This is a pilot study to explore the mechanistic effects of colchicine in patients with MI. The study will be conducted sequentially in 3 parts:
- Blood will be collected from up to 10 healthy volunteers for protocol development. (Group 1).
- Blood will be collected from 20 MI patients within 24 hours of presentation at New York University (NYU) Langone Medical Center and Bellevue Hospital Center (BHC). Neutrophil adhesion to human aortic endothelial cells, quantitative expression of adhesion molecules on the surface of neutrophils, quantitative levels of adhesion molecules on neutrophils and endothelial cells, and neutrophil metabolism, using a Seahorse Analyzer will be evaluated pre- and post-addition of in vitro colchicine. (Group 2)
- The standard low-dose loading regimen of colchicine (1.2 mg followed by 0.6 mg one hour later) will be administered to 20 patients with MI at BHC. Blood will be collected prior to drug administration, 2 to 3 hours after completion of the colchicine load, and 23 to 24 hours after the completion of the colchicine load. Neutrophil adhesion to human aortic endothelial cells, quantitative expression of adhesion molecules on the surface of neutrophils, quantitative levels of adhesion molecules on neutrophils and endothelial cells, and neutrophil metabolism will be evaluated pre- and post-addition of in vitro colchicine (exact markers will be determined based on the results of in viro studies above). (Group 3)
- Conditions
- Myocardial Infarction
- Being tested
- Colchicine 0.6 mg tablets
- Keywords
- myocardial infarction, colchicine, anti-inflammatory
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.6 mg tabletsDrug
1.2 mg PO followed by 0.6 mg PO 1 hour later
| Study group | Role | What they receive |
|---|---|---|
| Myocardial Infarction (MI) Patients | Experimental | Not described Receives: Drug: Colchicine 0.6 mg tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of neutrophils adherent to TNFα-stimulated endothelial cells
Metabolism of neutrophils will be measured using the Seahorse assay.
Measured: 1 Day
Secondary outcomes (3)
Levels of adhesion molecules on neutrophils and endothelial cells quantified using PCR
Metabolism of neutrophils will be measured using the Seahorse assay.
Measured: 1 Day
Expression of adhesion molecules on the surface of neutrophils assessed via flow cytometry
Measurements of L-selectin, CD11b, and active CD11b will be made via an Accuri C6 flow cytometer using standard antibodies on an aliquot of whole blood.
Measured: 1 Day
Measures of neutrophil metabolism (e.g. O2 consumption)
Metabolism of neutrophils will be measured using the Seahorse assay.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study start1 May 2017
- Primary completion12 Sep 2018
- Study completion12 Sep 2018
Why it stopped: feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binita Shah, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995512
- Sponsor's protocol ID
- 16-01704
- Status last verified
- Apr 2019
- First submitted
- 14 Dec 2016
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Effects of Colchicine in Patients With Myocardial Infarction A Single Center Phase 4 Single Arm Open-label Study Evaluating the FDA-approved Drug, Colchicine, at the FDA-approved Gout Dose in Patients With Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02995512
- Acronym / sponsor ID
- 16-01704
- Conditions
- Myocardial Infarction
- Keywords
- myocardial infarction, colchicine, anti-inflammatory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: feasibility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 16 Dec 2016 (estimated)
- 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.
The aim of this study is to determine the immuno-modulatory mechanistic effects of colchicine in patients with myocardial infarction (MI). Investigators hypothesize that colchicine exerts its anti-inflammatory properties by switching the metabolism of neutrophils, thereby reducing the expression of adhesion molecules responsible for their recruitment in MI.
Detailed description
This is a pilot study to explore the mechanistic effects of colchicine in patients with MI. The study will be conducted sequentially in 3 parts:
- Blood will be collected from up to 10 healthy volunteers for protocol development. (Group 1).
- Blood will be collected from 20 MI patients within 24 hours of presentation at New York University (NYU) Langone Medical Center and Bellevue Hospital Center (BHC). Neutrophil adhesion to human aortic endothelial cells, quantitative expression of adhesion molecules on the surface of neutrophils, quantitative levels of adhesion molecules on neutrophils and endothelial cells, and neutrophil metabolism, using a Seahorse Analyzer will be evaluated pre- and post-addition of in vitro colchicine. (Group 2)
- The standard low-dose loading regimen of colchicine (1.2 mg followed by 0.6 mg one hour later) will be administered to 20 patients with MI at BHC. Blood will be collected prior to drug administration, 2 to 3 hours after completion of the colchicine load, and 23 to 24 hours after the completion of the colchicine load. Neutrophil adhesion to human aortic endothelial cells, quantitative expression of adhesion molecules on the surface of neutrophils, quantitative levels of adhesion molecules on neutrophils and endothelial cells, and neutrophil metabolism will be evaluated pre- and post-addition of in vitro colchicine (exact markers will be determined based on the results of in viro studies above). (Group 3)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myocardial Infarction (MI) Patients | Experimental | Drug: Colchicine 0.6 mg tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age for the healthy volunteer subset.
- 18 years of age and within 24 hours of an MI for the MI subset.
Key exclusion criteria (11 listed)
- Subjects in all 3 groups will be excluded if they meet one of the following criteria
- history of myelodysplasia;
- Use of anti-inflammatory medications, with the exception of aspirin, within 5 half-lives;
- medications known to interact with colchicine;
- known creatinine clearance <30 cc/minute (severe kidney disease);
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 0.6 mg tablets1.2 mg PO followed by 0.6 mg PO 1 hour later | Drug | Myocardial Infarction (MI) Patients |
Primary outcome
Number of neutrophils adherent to TNFα-stimulated endothelial cells
Time frame: 1 Day
Metabolism of neutrophils will be measured using the Seahorse assay.
3 secondary outcomes
Levels of adhesion molecules on neutrophils and endothelial cells quantified using PCR
Time frame: 1 Day
Expression of adhesion molecules on the surface of neutrophils assessed via flow cytometry
Time frame: 1 Day
Measures of neutrophil metabolism (e.g. O2 consumption)
Time frame: 1 Day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
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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 Langone Health
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colchicine 0.6 mg tablets in people with Myocardial Infarction, run by NYU Langone Health.
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 2 inclusion and 11 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: withdrawn, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of neutrophils adherent to TNFα-stimulated endothelial cells (time frame: 1 Day). 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 18 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.