Anti-platelet Effects of Colchicine in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2014 |
| End Date: | January 2015 |
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.
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.
Inclusion Criteria:
- Subjects must be more than 18 years of age
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.
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