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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01603342
First received: May 16, 2012
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Haemostasis
Healthy
Drug: clopidogrel
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study to Determine the Impact of Clopidogrel (Plavix®) on Bleeding Associated With Punch Biopsies in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Bleeding duration measured in minutes [ Time Frame: From onset of bleeding till the end of the bleeding ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood volume reported in millilitres [ Time Frame: From onset of bleeding till the end of the bleeding ] [ Designated as safety issue: No ]
  • Adverse events, including special attention to bleeding complications [ Time Frame: From day 0 to days 11-17 ] [ Designated as safety issue: No ]
  • Change in coagulation-related parameters [ Time Frame: From baseline to 15 minutes after biopsy B1 ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: December 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: clopidogrel Drug: clopidogrel
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 Comparator: Placebo Drug: placebo
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01603342

Locations
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Neptune, New Jersey, United States, 07753
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Brett E. Skolnick, ph.D. Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01603342     History of Changes
Other Study ID Numbers: F7HAEM-1954
Study First Received: May 16, 2012
Last Updated: August 30, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 02, 2014