Platelet Inhibition by Aspirin, Acetaminophen and NSAID

September 27, 2007 updated by: Kantonsspital Graubünden
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Chur, Switzerland, CH 7000
        • Kantonsspital Graubünden, Department of Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
platelet aggregation
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Graubünden

Investigators

  • Principal Investigator: Walter H Reinhart, MD Professor, Department of Internal Medicine, Kantonsspital Graubunden CH7000 Chur Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 26, 2007

First Submitted That Met QC Criteria

September 26, 2007

First Posted (Estimate)

September 27, 2007

Study Record Updates

Last Update Posted (Estimate)

September 28, 2007

Last Update Submitted That Met QC Criteria

September 27, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KGWR0206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemostasis

Clinical Trials on Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe