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NCT00536068 Clinical Trial

Platelet Inhibition by Aspirin, Acetaminophen and NSAID

Hemostasis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00536068
Other study ID # KGWR0206
Secondary ID
Status Completed
Phase N/A
First received September 26, 2007
Last updated September 27, 2007
Start date August 2006
Est. completion date August 2007

Study information
Verified date September 2007
Source Kantonsspital Graubünden
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial Summary

Nonsteroidal antiinflammatory drugs such as diclofenac or naproxen may interfere with the inhibition of platelet aggregation by aspirin, because they all interact with the platelet cyclooxygenase.This may be of great clinical importance because of an increased cardiovascular event rate (myocardial infarction, stroke). The present randomized, controlled study analyses in vitro platelet aggregation under a combined treatment of healthy volunteers with aspirin and either acetaminophen, diclofenac, naproxen, or placebo.

Description:

An in vivo study on healthy volunteers with combinations of well established drugs

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Healthy volunteers

Exclusion Criteria:

- Administration of drugs affecting platelets

- History of bleeding

- Gastrointestinal disorders

- Hypersensitivity to aspirin and/or NSAID

- Pregnancy and breast feeding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placebo
Acetylsalicylic acid 100mg/po and acetaminophen 3x1g/po for 4 days Acetylsalicylic acid 100mg/po and diclofenac 3x50mg/po for 4 days Acetylsalicylic acid 100mg/po and naproxen 3x250mg/po for 4 days Acetylsalicylic acid 100mg/po and placebo 3x1/po for 4 days

Locations
Country Name City State
Switzerland Kantonsspital Graubünden, Department of Internal Medicine Chur

Sponsors (1)
Lead Sponsor Collaborator
Kantonsspital Graubünden

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary platelet aggregation 5 days
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