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Platelet Inhibition by Aspirin, Acetaminophen and NSAID

This study has been completed.
Sponsor:
Information provided by:
Kantonsspital Graubünden
ClinicalTrials.gov Identifier:
NCT00536068
First received: September 26, 2007
Last updated: September 27, 2007
Last verified: September 2007

September 26, 2007
September 27, 2007
August 2006
Not Provided
platelet aggregation [ Time Frame: 5 days ]
Same as current
Complete list of historical versions of study NCT00536068 on ClinicalTrials.gov Archive Site
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Platelet Inhibition by Aspirin, Acetaminophen and NSAID
Not Provided

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Hemostasis
Drug: Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placebo
  1. Acetylsalicylic acid 100mg/po and acetaminophen 3x1g/po for 4 days
  2. Acetylsalicylic acid 100mg/po and diclofenac 3x50mg/po for 4 days
  3. Acetylsalicylic acid 100mg/po and naproxen 3x250mg/po for 4 days
  4. Acetylsalicylic acid 100mg/po and placebo 3x1/po for 4 days
Experimental: 1, 2, 3, 4
  1. acetylsalicylic acid 100 mg/po,acetaminophen 3x1g/po
  2. acetylsalicylic acid 100 mg/po,diclofenac 3x50mg/po
  3. acetylsalicylic acid 100 mg/po,naproxen 3x250mg/po
  4. acetylsalicylic acid 100 mg/po,placebo 3x1/po
Intervention: Drug: Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
August 2007
Not Provided

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00536068
KGWR0206
No
Not Provided
Kantonsspital Graubünden
Not Provided
Principal Investigator: Walter H Reinhart, MD Professor Department of Internal Medicine, Kantonsspital Graubunden CH7000 Chur Switzerland
Kantonsspital Graubünden
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP