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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603342
• Other study ID #: F7HAEM-1954
• Status: Completed
• Phase: Phase 1
• First received: May 16, 2012
• Last updated: November 23, 2016
• Start date: December 2007
• Est. completion date: January 2008

Study information

• Verified date: November 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Haemostasis
• Healthy

Intervention

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
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

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Neptune	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding duration measured in minutes		From onset of bleeding till the end of the bleeding	No
Secondary	Blood volume reported in millilitres		From onset of bleeding till the end of the bleeding	No
Secondary	Adverse events, including special attention to bleeding complications		From day 0 to days 11-17	No
Secondary	Change in coagulation-related parameters		From baseline to 15 minutes after biopsy B1	No

External Links

•   Clinical Trials at Novo Nordisk