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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01603342

Enrollment

Registered

2012-05-22

Start date

2007-12-31

Completion date

2008-01-31

Last updated

2016-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemostasis, Healthy

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.

Interventions

DRUGclopidogrel

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

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Bleeding duration measured in minutes	From onset of bleeding till the end of the bleeding

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026