A Pilot Study to Determine the Impact of Clopidogrel (Plavix®) on Bleeding Associated With Punch Biopsies in Healthy Volunteers
- Registration Number
- NCT01603342
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in the United States of America (USA). The aim of this trial is to determine the feasibility of demonstrating a quantifiable change from baseline in punch biopsy-induced bleeding durations and blood loss volumes in healthy subjects after receiving clopidogrel anti-platelet therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
Inclusion Criteria
- PT within normal laboratory range
Exclusion Criteria
- The receipt of any investigational drug within 1 month prior to this trial
- Use of anti-coagulation or anti-platelet therapy-defined as vitamin K antagonists, platelet antagonists, heparin (or low molecular weight heparin), aspirin or NSAIDs within 30 days prior to trial
- African-American race
- Weight above or equal to 160 kg
- Recent diagnosis of any illness that would be present concomitant to trial period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description clopidogrel clopidogrel - Placebo placebo -
- Primary Outcome Measures
Name Time Method Bleeding duration measured in minutes From onset of bleeding till the end of the bleeding
- Secondary Outcome Measures
Name Time Method Blood volume reported in millilitres From onset of bleeding till the end of the bleeding Adverse events, including special attention to bleeding complications From day 0 to days 11-17 Change in coagulation-related parameters From baseline to 15 minutes after biopsy B1
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇺🇸Neptune, New Jersey, United States