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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Haemostasis

Treatments: Drug: clopidogrel; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01603342

F7HAEM-1954

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

clopidogrel

Experimental group

Treatment:

Drug: clopidogrel

Placebo

Placebo Comparator group

Treatment:

Drug: placebo