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Completed

NCT Number: NCT01603342

A Pilot Study to Determine the Impact of Clopidogrel (Plavix®) on Bleeding Associated With Punch Biopsies in Healthy Volunteers

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.

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Key information

Conditions

Haemostasis Healthy

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Neptune City, New Jersey, 07753, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel

Drug

Following a baseline punch biopsy, all subjects will then receive oral clopidogrel (Plavix®) over a period of approximately 3 to 4 days. Once the subject has successfully had 3 days of clopidogrel dosing, a second biopsy (B1) will be performed

Placebo

Drug

Following a baseline punch biopsy, all subjects will then receive oral placebo over a period of approximately 3 to 4 days. Once the subject has successfully had 3 days of clopidogrel dosing, a second biopsy will be performed

Primary outcomes

  1. Bleeding duration measured in minutes

    Time frame: From onset of bleeding till the end of the bleeding

Secondary outcomes

  1. Blood volume reported in millilitres

    Time frame: From onset of bleeding till the end of the bleeding

  2. Adverse events, including special attention to bleeding complications

    Time frame: From day 0 to days 11-17

  3. Change in coagulation-related parameters

    Time frame: From baseline to 15 minutes after biopsy B1

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 22, 2012
Registry last updated
Nov 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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