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| Name | Class |
|---|---|
| NYU Langone Health | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine | Active Comparator | Colchicine 1.8 mg PO over 1 hour |
|
| Placebo | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine vs Placebo | Drug | Colchicine vs Placebo 1.8 mg PO over 1 hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Peri-procedural Myocardial Necrosis | troponin above the upper limit of normal (ULN) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 30 days |
| Number of Participants With All-cause Mortality, Non-fatal MI, or TVR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Binita Shah, MD | Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | New York | New York | 10010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39344637 | Derived | 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. | |
| 32295417 | Derived | Shah 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Colchicine | Colchicine 1.8 mg PO over 1 hour Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour |
| FG001 | Placebo | Matching placebo Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Colchicine | Colchicine 1.8 mg PO over 1 hour Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour |
| BG001 | Placebo | Matching placebo Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Peri-procedural Myocardial Necrosis | troponin above the upper limit of normal (ULN) | Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol) | Posted | Count of Participants | Participants | 24 hours |
|
For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years
Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Colchicine | Colchicine 1.8 mg PO over 1 hour Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI distress | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | Non-systematic Assessment | Unrelated to study medication |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Binita Shah | VA NY Harbor Healthcare System | 212-686-7500 | binita.shah@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 7, 2019 | Oct 2, 2019 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2019 | Oct 2, 2019 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D054058 | Acute Coronary Syndrome |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR) |
| 1 year |
| All-cause Mortality, Non-fatal MI, or TVR | all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR) | 2 years |
| All-cause Mortality, Non-fatal MI, or TVR | all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR) | 3 years |
| All-cause Mortality, Non-fatal MI, or TVR | all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR) | 4 years |
| All-cause Mortality, Non-fatal MI, or TVR | all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR) | 5 years |
| Number of Participants With Peri-procedural Myocardial Infarction (MI) | SCAI definition | 24 hours |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Secondary | 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) | Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol) | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | 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) | Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol) | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | All-cause Mortality, Non-fatal MI, or TVR | all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR) | Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol) | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | All-cause Mortality, Non-fatal MI, or TVR | all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR) | Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol) | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | All-cause Mortality, Non-fatal MI, or TVR | all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR) | Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol) | Posted | Count of Participants | Participants | 4 years |
|
|
|
| Secondary | All-cause Mortality, Non-fatal MI, or TVR | all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR) | Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol) | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Number of Participants With Peri-procedural Myocardial Infarction (MI) | SCAI definition | Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol) | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| 26 |
| 206 |
| 72 |
| 366 |
| 67 |
| 366 |
| EG001 | Placebo | Matching placebo Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour | 29 | 194 | 79 | 348 | 36 | 348 |
| Chest pain | Cardiac disorders | Non-systematic Assessment |
|
| Access site discomfort | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hemodynamic instability | General disorders | Non-systematic Assessment |
|
| Fever | Immune system disorders | Non-systematic Assessment |
|
| Elevated creatinine | Renal and urinary disorders | Non-systematic Assessment |
|
| Ischemic stroke | Vascular disorders | Non-systematic Assessment |
|
| Fluid overload | General disorders | Non-systematic Assessment |
|
| Bleeding | General disorders | Non-systematic Assessment |
|
| all-cause mortality | Cardiac disorders | Non-systematic Assessment |
|
| myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| target vessel revascularization | Cardiac disorders | Non-systematic Assessment |
|
| PCI-related myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Gastrointestinal symptoms | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |