Anti-platelet Effects of Colchicine in Healthy Volunteers
1 other identifier
interventional
10
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 healthy
Started May 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 14, 2014
CompletedFirst Posted
Study publicly available on registry
May 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedResults Posted
Study results publicly available
February 23, 2016
CompletedFebruary 23, 2016
January 1, 2016
8 months
May 14, 2014
January 26, 2016
January 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Monocyte Platelet Aggregate: Baseline
Baseline
Monocyte Platelet Aggregate: 2 Hours
2 Hours
Secondary Outcomes (6)
Light Transmission Aggregometry: Baseline
Baseline
Light Transmission Aggregometry: 2 Hours
2 hours
Light Transmission Aggregometry: Baseline
baseline
Light Transmission Aggregometry: 2 Hours
2 hours
Platelet Adhesion: Baseline
Baseline
- +1 more secondary outcomes
Study Arms (1)
Volunteer group
EXPERIMENTALBaseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later
Interventions
Colchicine 1.2 mg followed by 0.6 mg one hour later
Eligibility Criteria
You may qualify if:
- Subjects must be more than 18 years of age
You may not qualify if:
- \) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Binita Shah
- Organization
- NYU School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Binita Shah, MD, MS
NYU SOM
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2014
First Posted
May 16, 2014
Study Start
May 1, 2014
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
February 23, 2016
Results First Posted
February 23, 2016
Record last verified: 2016-01