Platelet Inhibition by Aspirin, Acetaminophen and NSAID - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 26, 2007

Last Updated Date

September 27, 2007

Start Date ^†

August 2006

Current Primary Outcome Measures ^†

platelet aggregation [ Time Frame: 5 days ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00536068 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Platelet Inhibition by Aspirin, Acetaminophen and NSAID

Official Title ^†

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.

Detailed Description

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

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

Hemostasis

Intervention ^†

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

Study Arms / Comparison Groups

Experimental:

acetylsalicylic acid 100 mg/po,acetaminophen 3x1g/po
acetylsalicylic acid 100 mg/po,diclofenac 3x50mg/po
acetylsalicylic acid 100 mg/po,naproxen 3x250mg/po
acetylsalicylic acid 100 mg/po,placebo 3x1/po

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

August 2007

Primary Completion Date

Eligibility 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

Gender

Both

Ages

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Switzerland

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00536068

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Kantonsspital Graubünden

Collaborators ^††

Investigators ^†

Principal Investigator:

Walter H Reinhart, MD Professor

Department of Internal Medicine, Kantonsspital Graubunden CH7000 Chur Switzerland

Information Provided By

Kantonsspital Graubünden

Verification Date

September 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.