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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
History of Changes
  Purpose

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 Intervention
Hemostasis
 Drug: Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placebo

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kantonsspital Graubünden:

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

Enrollment: 11
Study Start Date: August 2006
Study Completion Date: August 2007
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00536068     History of Changes
Other Study ID Numbers: KGWR0206
Study First Received: September 26, 2007
Last Updated: September 27, 2007
Health Authority: Switzerland: Swissmedic

Keywords provided by Kantonsspital Graubünden:
platelet
aggregation
aspirin

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

ClinicalTrials.gov processed this record on May 21, 2013