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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
Peri-procedural inflammation is associated with increased rates of post-procedural myocardial infarction (MI), which occur in up to 35% of PCI patients and are themselves associated with increased risk of later MI and death. Statins suppress both inflammatory markers and MI rates during and after PCI, but ≥ 40% of PCI patients go statin-untreated, due in part to side effects such as myalgia. Moreover, because their mechanism of action relies on post-translational effects, statins must be given ≥ 12 to 24 hours prior to PCI, a time frame that is not always feasible. The investigators propose a novel alternative approach to reduce inflammation during PCI employing colchicine, an anti-inflammatory medication used frequently in gout and pericarditis. Colchicine may be particularly applicable to the PCI setting due to its rapid onset of action and excellent side-effect profile at low doses, as well as its known mechanisms of action. However, data on colchicine use in patients with coronary disease is extremely limited, and no studies to date have evaluated the use of colchicine in patients undergoing PCI. The investigators aim to characterize a potential mechanism of benefit in patients undergoing PCI by evaluating the effects of colchicine on soluble and leukocyte surface markers after PCI. The investigators also aim to determine the effects of colchicine on peri-procedural myonecrosis and MI. Accordingly, the investigators propose a prospective randomized study to characterize the effect of colchicine on inflammation and peri-procedural myocnecrosis. Patients referred for possible PCI will be randomized in a double-blinded fashion to placebo or colchicine (1.2mg 1 to 2 hours before PCI, followed by 0.6mg 1 hour later). The primary endpoint will be post-procedural interleukin-6 level. Secondary endpoints will include other relevant soluble and leukocyte-associated inflammatory markers. Sample size needed is 200 patients undergoing PCI. To adjust for a floor effect, 280 patients undergoing PCI will be needed. 400 patients will likely be needed to be enrolled to reach 280 PCIs (the remaining will have undergone a diagnostic only procedure). Of note, this is a substudy of the COLCHICINE-PCI trial (NCT 02594111)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine | Experimental | 1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later |
|
| Placebo | Placebo Comparator | Placebo 1-2 hours prior PCI, followed by placebo 1 hour later |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Post-procedural IL-6 Concentration From Baseline to 30 Min -1 hr After PCI | 30 minutes to 1 hour after PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Post-procedural IL-6 Concentration From Baseline to 22-24 hr After PCI | baseline to 22-24 hr after PCI | |
| Percent Change in Post-procedural hsCRP Concentration From Baseline to 22-24 hr After PCI | baseline to 22-24 hr after PCI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Binita Shah, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manhattan VA Hospital | New York | New York | 10010 | United States | ||
| Bellevue Hospital Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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 | 1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later |
| FG001 | Placebo | Placebo 1-2 hours prior PCI, followed by placebo 1 hour later Placebo: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Colchicine | Colchicine |
| BG001 | Placebo | Placebo |
| BG002 |
| 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 | Percent Change in Post-procedural IL-6 Concentration From Baseline to 30 Min -1 hr After PCI | Posted | Median | Inter-Quartile Range | % change | 30 minutes to 1 hour after PCI |
|
30 days, 6 months, and yearly for 5 years
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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 | 1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Binita Shah | NYU Langone Health | 212-263-6631 | Binita.Shah@nyulangone.org |
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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 | Sep 26, 2019 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2019 | Sep 26, 2019 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later |
|
| Percent Change in Post-procedural IL-1B Concentration From Baseline to 30 Min -1 hr After PCI | 30 minutes to 1 hour after PCI |
| Percent Change in Post-procedural IL-1B Concentration From Baseline to 30 Min -1 hr After PCI | baseline to 22-24 hr after PCI |
| New York |
| New York |
| 10016 |
| United States |
| New York Langone Medical Center | New York | New York | 10016 | United States |
| 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 | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Percent Change in Post-procedural IL-6 Concentration From Baseline to 22-24 hr After PCI | Posted | Median | Inter-Quartile Range | % change | baseline to 22-24 hr after PCI |
|
|
|
| Secondary | Percent Change in Post-procedural hsCRP Concentration From Baseline to 22-24 hr After PCI | Posted | Median | Inter-Quartile Range | % change | baseline to 22-24 hr after PCI |
|
|
|
| Secondary | Percent Change in Post-procedural IL-1B Concentration From Baseline to 30 Min -1 hr After PCI | Posted | Median | Inter-Quartile Range | % change | 30 minutes to 1 hour after PCI |
|
|
|
| Secondary | Percent Change in Post-procedural IL-1B Concentration From Baseline to 30 Min -1 hr After PCI | Posted | Median | Inter-Quartile Range | % change | baseline to 22-24 hr after PCI |
|
|
|
| 0 |
| 141 |
| 2 |
| 141 |
| 0 |
| 141 |
| EG001 | Placebo | Placebo 1-2 hours prior PCI, followed by placebo 1 hour later Placebo: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later | 0 | 139 | 6 | 139 | 0 | 139 |
| Ischemic stroke | Vascular disorders | Non-systematic Assessment |
|
| Fever | Immune system disorders | Non-systematic Assessment |
|
| Hemodynamic instabiity | General disorders | Non-systematic Assessment |
|
| Elevated creatinine | Renal and urinary disorders | Non-systematic Assessment |
|
| Bleeding | General disorders | Non-systematic Assessment |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |