Anti-platelet Effects of Colchicine in Healthy Volunteers
Information source: New York University School of Medicine
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Colchicine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: New York University School of Medicine Official(s) and/or principal investigator(s):
Binita Shah, MD, MS, Principal Investigator, Affiliation: NYU SOM
Summary
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.
Clinical Details
Official title: Anti-platelet Effects of Colchicine in Healthy Volunteers
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: monocyte platelet aggregate
Secondary outcome: leukocyte platelet aggregationlight transmission aggregometry L-selectin platelet adhesion
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
New York University School of Medicine, New York, New York 10016, United States
Additional Information
Starting date: May 2014
Last updated: February 2, 2015
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