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Platelet Inhibition by Aspirin, Acetaminophen and NSAID

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ClinicalTrials.gov Identifier: NCT00536068
Recruitment Status : Completed
First Posted : September 27, 2007
Last Update Posted : September 28, 2007
Sponsor:
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

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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00536068


Locations
Switzerland
Kantonsspital Graubünden, Department of Internal Medicine
Chur, Switzerland, CH 7000
Sponsors and Collaborators
Kantonsspital Graubünden
Investigators
Principal Investigator: Walter H Reinhart, MD Professor Department of Internal Medicine, Kantonsspital Graubunden CH7000 Chur Switzerland

ClinicalTrials.gov Identifier: NCT00536068     History of Changes
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:
platelet
aggregation
aspirin

Additional relevant MeSH terms:
Aspirin
Diclofenac
Naproxen
Acetaminophen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Gout Suppressants