Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a pilot study. Volunteers will be given 1.8 mg (1.2 mg followed by 0.6 mg one hour later), 1.2 mg, or 0.6 mg of colchicine. Blood will be collected prior to drug administration, 2 hours after colchicine administration, and 24 hours after colchicine administration via the antecubital vein and evaluated for markers of platelet activity and inflammation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volunteer group | Experimental | Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | Colchicine 1.2 mg followed by 0.6 mg one hour later |
|
| Measure | Description | Time Frame |
|---|---|---|
| Monocyte Platelet Aggregate: Baseline | Baseline | |
| Monocyte Platelet Aggregate: 2 Hours | 2 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Light Transmission Aggregometry: Baseline | In response to adenosine diphosphate | Baseline |
| Light Transmission Aggregometry: 2 Hours | In response to adenosine diphosphate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
1) history of cardiovascular disease, including myocardial infarction, history of percutaneous coronary angioplasty or stent, peripheral vascular disease or stroke; 2) history of myelodysplasia; 3) medications known to affect platelet function, including non-steroidal anti-inflammatory drugs, antihistamines, and selective serotonin reuptake inhibitors, during the 5 days prior to participation; 4) medications known to interact with colchicine; 5) history of intolerance to colchicine; 6) acute or chronic symptoms of diarrhea, nausea, or vomiting within 1 month prior to enrollment; 7) known anemia or hemoglobin <10mg/dL; 8) platelet count <100,000 or > 450,000; 9) creatinine clearance <30cc/minute; 10) any known hemorrhagic diathesis; 11) pregnant; 12) Unable to consent; or 13) Participating in a competing study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Binita Shah, MD, MS | NYU SOM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Volunteer Group | Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Volunteer Group | Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Monocyte Platelet Aggregate: Baseline | Posted | Median | Inter-Quartile Range | percentage of monocyte-platelet aggregat | Baseline |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Volunteer Group | Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Binita Shah | NYU School of Medicine | 212-263-4235 | binita.shah@nyumc.org |
Not provided
| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2 hours |
| Light Transmission Aggregometry: Baseline | In response to adenosine epinephrine | baseline |
| Light Transmission Aggregometry: 2 Hours | In response to adenosine epinephrine | 2 hours |
| Platelet Adhesion: Baseline | Baseline |
| Platelet Adhesion: 2 Hours | 2 hours |
| Participants |
|
| 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 |
|
|
| Secondary | Light Transmission Aggregometry: Baseline | In response to adenosine diphosphate | Posted | Median | Inter-Quartile Range | percentage of max platelet aggregation | Baseline |
|
|
|
| Primary | Monocyte Platelet Aggregate: 2 Hours | Posted | Median | Inter-Quartile Range | percentage of monocyte-platelet aggregat | 2 Hours |
|
|
|
| Secondary | Light Transmission Aggregometry: 2 Hours | In response to adenosine diphosphate | Posted | Median | Inter-Quartile Range | percentage of max platelet aggregation | 2 hours |
|
|
|
| Secondary | Light Transmission Aggregometry: Baseline | In response to adenosine epinephrine | Posted | Median | Inter-Quartile Range | percentage of max platelet aggregation | baseline |
|
|
|
| Secondary | Light Transmission Aggregometry: 2 Hours | In response to adenosine epinephrine | Posted | Median | Inter-Quartile Range | percentage of max platelet aggregation | 2 hours |
|
|
|
| Secondary | Platelet Adhesion: Baseline | Posted | Median | Inter-Quartile Range | percentage of adhered platelets | Baseline |
|
|
|
| Secondary | Platelet Adhesion: 2 Hours | Posted | Median | Inter-Quartile Range | percentage of adhered platelets | 2 hours |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
Not provided
Not provided
Not provided