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Platelet Inhibition by Aspirin, Acetaminophen and NSAID

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00536068
Recruitment Status : Completed
First Posted : September 27, 2007
Last Update Posted : September 28, 2007
Information provided by:
Kantonsspital Graubünden

Brief 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.

Condition or disease Intervention/treatment Phase
Hemostasis Drug: Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placebo Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : August 2006
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
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

Primary Outcome Measures :
  1. platelet aggregation [ Time Frame: 5 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00536068

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Kantonsspital Graubünden, Department of Internal Medicine
Chur, Switzerland, CH 7000
Sponsors and Collaborators
Kantonsspital Graubünden
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Principal Investigator: Walter H Reinhart, MD Professor Department of Internal Medicine, Kantonsspital Graubunden CH7000 Chur Switzerland
Layout table for additonal information Identifier: NCT00536068    
Other Study ID Numbers: KGWR0206
First Posted: September 27, 2007    Key Record Dates
Last Update Posted: September 28, 2007
Last Verified: September 2007
Keywords provided by Kantonsspital Graubünden:
Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gout Suppressants
Fibrinolytic Agents
Fibrin Modulating Agents