Coronary Artery DiseasePhase 4Colchicine-PCINCT02594111
Colchicine in Percutaneous Coronary Intervention
A Phase 4 study of Coronary Artery Disease and Acute Coronary Syndrome, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Inflammation in the arteries of the heart may increase the risk of cardiac death. The proposed research seeks to identify the potential beneficial role of a safe anti-inflammatory medication, colchicine, on reducing damage caused by opening up a blockage in the arteries of the heart. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 714 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2013to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referred for possible PCI
Who cannot join
- Colchicine use within 1 month
- History of colchicine intolerance
- Glomerular filtration rate <30mL/minute or on dialysis (due to the need to adjust colchicine dose in this setting)
- Active malignancy or infection (major confounder with increased inflammatory markers)
- History of myelodysplasia (due to suggested cautionary use of colchicine in this setting)
- High-dose statin load <24 hours prior to procedure (major confounder that is known to reduce inflammatory levels in 12 to 24 hours)
Show all 11Show fewer
- Use of anti-inflammatory agents (except aspirin) within 5 halflives of the individual drug
- Use of strong Cytochrome P450, Family 3, Subfamily A, Polypeptide 4 (CYP3A4) and/or P-glycoprotein inhibitors (e.g. ritonavir, ketoconazole, clarithromycin, cyclosporine, diltiazem and verapamil, again due to drug interactions)
- Unable to consent
- Participating in a competing study
- Any significant condition or situation that may put the subject at higher risk, confound the study results or interfere with adherence to study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010
About this study
Official title: Anti-inflammatory Therapy During Percutaneous Coronary Intervention
Inflammation in the arteries of the heart may increase the risk of cardiac death. The proposed research seeks to identify the potential beneficial role of a safe anti-inflammatory medication, colchicine, on reducing damage caused by opening up a blockage in the arteries of the heart. With its quick onset of action and excellent safety profile, colchicine may have the potential to reduce risk of major adverse events related to the heart. This research also seeks to better understand the role of neutrophils, the most common type of inflammatory white blood cell in the body, when there is damage to the heart.
Read the detailed description
The investigators will use colchicine as a tool to elucidate the role of neutrophil activation during acute vascular injury, and to explore the association between neutrophil activation and adverse cardiovascular outcomes. Colchicine reduces cell surface expression of selections, adhesion molecules key to neutrophil recruitment after vascular injury. Daily colchicine use is associated with reduced adverse cardiovascular events in stable atherosclerosis. Using a clinical percutaneous coronary intervention (PCI) model, the investigators evaluate whether pre-procedural colchicine (1.8 mg oral load over one hour) reduces the rate of post-PCI adverse cardiovascular outcomes in the context of a double-blind placebo-controlled randomized study. The investigators will also characterize neutrophil biology in acute vascular injury and the effects of colchicine on neutrophil biology in this setting.
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Being tested
- Colchicine vs Placebo
- Keywords
- inflammation, percutaneous coronary intervention, coronary artery disease, colchicine
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine vs PlaceboDrug
Colchicine vs Placebo 1.8 mg PO over 1 hour
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Active comparator | Colchicine 1.8 mg PO over 1 hour Receives: Drug: Colchicine vs Placebo |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Colchicine vs Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Peri-procedural Myocardial Necrosis
troponin above the upper limit of normal (ULN)
Measured: 24 hours
Secondary outcomes (7)
Number of Participants With All-cause Mortality, Non-fatal MI, or Target Vessel Revascularization (TVR)
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Measured: 30 days
Number of Participants With All-cause Mortality, Non-fatal MI, or TVR
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Measured: 1 year
All-cause Mortality, Non-fatal MI, or TVR
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Measured: 2 years
All-cause Mortality, Non-fatal MI, or TVR
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Measured: 3 years
All-cause Mortality, Non-fatal MI, or TVR
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Measured: 4 years
All-cause Mortality, Non-fatal MI, or TVR
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Measured: 5 years
Number of Participants With Peri-procedural Myocardial Infarction (MI)
SCAI definition
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study start30 May 2013
- Primary completion30 Aug 2019
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 714 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- NYU Langone Health
- Responsible party
- Sponsor
- Investigators
- Binita Shah, MD, Principal investigator, Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594111
- Sponsor's protocol ID
- CARB-025-15S
- Acronym
- Colchicine-PCI
- Status last verified
- Jan 2023
- First submitted
- 30 Oct 2015
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Talmor N, Pillinger MH, Xia Y, Leonard A, Curovic F, Shah B. Neutrophil Activation and Adhesiveness in Coronary Artery Disease: Results From the COLCHICINE-PCI Biomarker Substudy. J Am Heart Assoc. 2024 Oct;13(19):e036701. doi: 10.1161/JAHA.124.036701. Epub 2024 Sep 30.
PubMed 39344637Shah B, Pillinger M, Zhong H, Cronstein B, Xia Y, Lorin JD, Smilowitz NR, Feit F, Ratnapala N, Keller NM, Katz SD. Effects of Acute Colchicine Administration Prior to Percutaneous Coronary Intervention: COLCHICINE-PCI Randomized Trial. Circ Cardiovasc Interv. 2020 Apr;13(4):e008717. doi: 10.1161/CIRCINTERVENTIONS.119.008717. Epub 2020 Apr 16.
PubMed 32295417
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-inflammatory Therapy During Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT02594111
- Acronym / sponsor ID
- Colchicine-PCI / CARB-025-15S
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Keywords
- inflammation, percutaneous coronary intervention, coronary artery disease, colchicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 714 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- NYU Langone Health
- Study start
- 30 May 2013 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Nov 2015 (estimated)
- Results
- Posted 10 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inflammation in the arteries of the heart may increase the risk of cardiac death. The proposed research seeks to identify the potential beneficial role of a safe anti-inflammatory medication, colchicine, on reducing damage caused by opening up a blockage in the arteries of the heart. With its quick onset of action and excellent safety profile, colchicine may have the potential to reduce risk of major adverse events related to the heart. This research also seeks to better understand the role of neutrophils, the most common type of inflammatory white blood cell in the body, when there is damage to the heart.
Detailed description
The investigators will use colchicine as a tool to elucidate the role of neutrophil activation during acute vascular injury, and to explore the association between neutrophil activation and adverse cardiovascular outcomes. Colchicine reduces cell surface expression of selections, adhesion molecules key to neutrophil recruitment after vascular injury. Daily colchicine use is associated with reduced adverse cardiovascular events in stable atherosclerosis. Using a clinical percutaneous coronary intervention (PCI) model, the investigators evaluate whether pre-procedural colchicine (1.8 mg oral load over one hour) reduces the rate of post-PCI adverse cardiovascular outcomes in the context of a double-blind placebo-controlled randomized study. The investigators will also characterize neutrophil biology in acute vascular injury and the effects of colchicine on neutrophil biology in this setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Active comparator | Drug: Colchicine vs PlaceboColchicine 1.8 mg PO over 1 hour |
| Placebo | Placebo comparator | Drug: Colchicine vs PlaceboMatching placebo |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Referred for possible PCI
Key exclusion criteria (11 listed)
- Colchicine use within 1 month
- History of colchicine intolerance
- Glomerular filtration rate <30mL/minute or on dialysis (due to the need to adjust colchicine dose in this setting)
- Active malignancy or infection (major confounder with increased inflammatory markers)
- History of myelodysplasia (due to suggested cautionary use of colchicine in this setting)
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 vs PlaceboColchicine vs Placebo 1.8 mg PO over 1 hour | Drug | Colchicine, Placebo |
Primary outcome
Number of Participants With Peri-procedural Myocardial Necrosis
Time frame: 24 hours
troponin above the upper limit of normal (ULN)
7 secondary outcomes
Number of Participants With All-cause Mortality, Non-fatal MI, or Target Vessel Revascularization (TVR)
Time frame: 30 days
Number of Participants With All-cause Mortality, Non-fatal MI, or TVR
Time frame: 1 year
All-cause Mortality, Non-fatal MI, or TVR
Time frame: 2 years
All-cause Mortality, Non-fatal MI, or TVR
Time frame: 3 years
All-cause Mortality, Non-fatal MI, or TVR
Time frame: 4 years
All-cause Mortality, Non-fatal MI, or TVR
Time frame: 5 years
Number of Participants With Peri-procedural Myocardial Infarction (MI)
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39344637Talmor N, Pillinger MH, Xia Y, Leonard A, Curovic F, Shah B. Neutrophil Activation and Adhesiveness in Coronary Artery Disease: Results From the COLCHICINE-PCI Biomarker Substudy. J Am Heart Assoc. 2024 Oct;13(19):e036701. doi: 10.1161/JAHA.124.036701. Epub 2024 Sep 30.
- Derived from this study: PubMed 32295417Shah B, Pillinger M, Zhong H, Cronstein B, Xia Y, Lorin JD, Smilowitz NR, Feit F, Ratnapala N, Keller NM, Katz SD. Effects of Acute Colchicine Administration Prior to Percutaneous Coronary Intervention: COLCHICINE-PCI Randomized Trial. Circ Cardiovasc Interv. 2020 Apr;13(4):e008717. doi: 10.1161/CIRCINTERVENTIONS.119.008717. Epub 2020 Apr 16.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingObservational study
Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
Cardiovascular Diseases
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Coronary Artery Disease, Coronary Artery Stenoses
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
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Coronary Artery Disease and Acute Coronary Syndrome, run by VA Office of Research and Development 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 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: finished, as of the sponsor's last update on 21 Feb 2023. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 10 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Peri-procedural Myocardial Necrosis (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02594111, which also lists 2 linked publications.
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 21 Feb 2023.