Reproducibility and Comparison of Platelet Function Assays With Aspirin and Clopidogrel (MK-0000-167)

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Cross-over Study Using Aspirin and Clopidogrel to Assess Reproducibility and Compare Platelet Function Assays

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108588
• Other study ID #: 0000-167
• Secondary ID: 167
• Status: Completed
• Phase: Phase 1
• First received: April 20, 2010
• Last updated: August 11, 2015
• Start date: June 2010
• Est. completion date: August 2010

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

This study will evaluate whether the antiplatelet effects of Aspirin 300 mg daily and Clopidogrel 75 mg daily can be reproducibly measured using several point of care platelet function assays

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Subject has BMI (Body Mass Index) less than 32 kg/m^ 2

• Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 3 months

• Subject does not have a history of any bleeding disorder

Exclusion Criteria:

• Subject is a pregnant or nursing female

• Subject has a history of multiple and/or severe allergies to drugs or foods, or any history (personal or family) of bleeding disorders (including arterial bleeding, hemorrhage requiring transfusion or urgent intervention)

• Subject currently uses on a regular basis or has used aspirin or clopidogrel within 21 days prior to screening (including low-dose aspirin and pain relievers, cold, or sinus remedies containing aspirin)

• Subject currently uses on a regular basis or has used within 2 weeks prior to study start, any other prescription or nonprescription drugs, including NSAIDs such as ibuprofen, naproxen, COX-II inhibitors such as celecoxib or etoricoxib, other pain relievers, cold, or sinus remedies containing NSAIDs, and herbal remedies (e.g., St. John Wort)

• Subject anticipates needing during the study any prescription or nonprescription (including over the counter) preparation, including those that contain aspirin, ibuprofen, or any other NSAID or NSAID-containing product commonly found in pain relievers, cold or sinus remedies

• Subject has a history of skin conditions (such as dry skin, pruritus, rosacea, eczema) or has a sun burn at the time of screening and is unwilling to avoid excessive sun exposure for the duration of the study

• Subject regularly uses antacids or other OTC medications (4 or more times per month) for symptoms of dyspepsia or has a history of use of prescription ulcer medication such as H2 blockers (e.g., cimetidine, ranitidine, famotidine, nizatidine) or a proton pump inhibitor (omeprazole) within the last 5 years

• Subject has a history of poor wound healing or a tendency to form keloids

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Placebo (to match Aspirin)
Placebo grossly matched Aspirin 300 mg daily
• Aspirin
Aspirin 300 mg daily
• Clopidogrel
Clopidogrel 75 mg daily
• Comparator: Placebo (to match Clopidogrel)
Placebo (grossly matched Clopidogrel 75 mg) daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect size of light transmission platelet aggregation, bleeding time, and several point of care platelet function assays after 3 days of administration of study drug compared to placebo treatment.		Baseline and 3 days	No
Primary	The intra-subject coefficient of variation of each of the 3 platelet function devices		Baseline and 3 days	No