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

NCT ID: NCT01108588

Last Updated: 2015-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2010-08-31

Brief 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

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sequence 1

Aspirin - Clopidogrel - Placebo

Group Type: EXPERIMENTAL

Placebo (to match Aspirin)

Intervention Type: DRUG

Placebo grossly matched Aspirin 300 mg daily

Aspirin

Intervention Type: DRUG

Aspirin 300 mg daily

Clopidogrel

Intervention Type: DRUG

Clopidogrel 75 mg daily

Comparator: Placebo (to match Clopidogrel)

Intervention Type: DRUG

Placebo (grossly matched Clopidogrel 75 mg) daily

Sequence 2

Clopidogrel - Placebo - Aspirin

Group Type: EXPERIMENTAL

Placebo (to match Aspirin)

Intervention Type: DRUG

Placebo grossly matched Aspirin 300 mg daily

Aspirin

Intervention Type: DRUG

Aspirin 300 mg daily

Clopidogrel

Intervention Type: DRUG

Clopidogrel 75 mg daily

Comparator: Placebo (to match Clopidogrel)

Intervention Type: DRUG

Placebo (grossly matched Clopidogrel 75 mg) daily

Sequence 3

Placebo - Aspirin - Clopidogrel

Group Type: EXPERIMENTAL

Placebo (to match Aspirin)

Intervention Type: DRUG

Placebo grossly matched Aspirin 300 mg daily

Aspirin

Intervention Type: DRUG

Aspirin 300 mg daily

Clopidogrel

Intervention Type: DRUG

Clopidogrel 75 mg daily

Comparator: Placebo (to match Clopidogrel)

Intervention Type: DRUG

Placebo (grossly matched Clopidogrel 75 mg) daily

Sequence 4

Aspirin - Placebo - Clopidogrel

Group Type: EXPERIMENTAL

Placebo (to match Aspirin)

Intervention Type: DRUG

Placebo grossly matched Aspirin 300 mg daily

Aspirin

Intervention Type: DRUG

Aspirin 300 mg daily

Clopidogrel

Intervention Type: DRUG

Clopidogrel 75 mg daily

Comparator: Placebo (to match Clopidogrel)

Intervention Type: DRUG

Placebo (grossly matched Clopidogrel 75 mg) daily

Sequence 5

Clopidogrel - Aspirin - Placebo

Group Type: EXPERIMENTAL

Placebo (to match Aspirin)

Intervention Type: DRUG

Placebo grossly matched Aspirin 300 mg daily

Aspirin

Intervention Type: DRUG

Aspirin 300 mg daily

Clopidogrel

Intervention Type: DRUG

Clopidogrel 75 mg daily

Comparator: Placebo (to match Clopidogrel)

Intervention Type: DRUG

Placebo (grossly matched Clopidogrel 75 mg) daily

Sequence 6

Placebo - Clopidogrel - Aspirin

Group Type: EXPERIMENTAL

Placebo (to match Aspirin)

Intervention Type: DRUG

Placebo grossly matched Aspirin 300 mg daily

Aspirin

Intervention Type: DRUG

Aspirin 300 mg daily

Clopidogrel

Intervention Type: DRUG

Clopidogrel 75 mg daily

Comparator: Placebo (to match Clopidogrel)

Intervention Type: DRUG

Placebo (grossly matched Clopidogrel 75 mg) daily

Interventions

Placebo (to match Aspirin)

Placebo grossly matched Aspirin 300 mg daily

Intervention Type: DRUG

Aspirin

Aspirin 300 mg daily

Intervention Type: DRUG

Clopidogrel

Clopidogrel 75 mg daily

Intervention Type: DRUG

Comparator: Placebo (to match Clopidogrel)

Placebo (grossly matched Clopidogrel 75 mg) daily

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Chen F, Maridakis V, O'neill EA, Beals C, Radziszewski W, de Lepeleire I, Van Dyck K, Depre M, Bolognese JA, de Hoon J, Jacquemin M. A randomized clinical trial comparing point-of-care platelet function assays and bleeding time in healthy subjects treated with aspirin or clopidogrel. Platelets. 2012;23(4):249-58. doi: 10.3109/09537104.2011.604806. Epub 2011 Sep 15.

Reference Type: DERIVED

PMID: 21919555 (View on PubMed)

Other Identifiers

167

Identifier Type: -

Identifier Source: secondary_id

0000-167

Identifier Type: -

Identifier Source: org_study_id