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Platelet Inhibition by Aspirin, Acetaminophen and NSAID

NCT ID: NCT00536068

Last Updated: 2007-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-08-31

Brief Summary

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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

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

Conditions

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Hemostasis

Keywords

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platelet aggregation aspirin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kantonsspital Graubünden

OTHER

Sponsor Role lead

Principal Investigators

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Walter H Reinhart, MD Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Kantonsspital Graubunden CH7000 Chur Switzerland

Locations

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Kantonsspital Graubünden, Department of Internal Medicine

Chur, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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KGWR0206

Identifier Type: -

Identifier Source: org_study_id