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

Phase 1

Completed

• Conditions: Haemostasis; Healthy
• Interventions: Drug: clopidogrel; Drug: placebo

• 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

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2012-05-16
• Study First Submitted QC: 2012-05-21
• Study First Posted: 2012-05-22
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-25

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