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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 aggregation

light 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

Page last updated: August 20, 2015

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