NCT00536068

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
Last Updated

September 28, 2007

Status Verified

September 1, 2007

First QC Date

September 26, 2007

Last Update Submit

September 27, 2007

Conditions

Hemostasis

Keywords

plateletaggregationaspirin

Outcome Measures

Primary Outcomes (1)

  • platelet aggregation

    5 days

Study Arms (1)

1, 2, 3, 4

EXPERIMENTAL

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

Interventions

Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placeboDRUG

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

1, 2, 3, 4

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • Administration of drugs affecting platelets
  • History of bleeding
  • Gastrointestinal disorders
  • Hypersensitivity to aspirin and/or NSAID
  • Pregnancy and breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Graubünden, Department of Internal Medicine

Chur, CH 7000, Switzerland

Location

MeSH Terms

Interventions

AspirinAcetaminophenDiclofenacNaproxen

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAminesPhenylacetatesAcids, CarbocyclicCarboxylic AcidsNaphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Walter H Reinhart, MD Professor

    Department of Internal Medicine, Kantonsspital Graubunden CH7000 Chur Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2007

First Posted

September 27, 2007

Study Start

August 1, 2006

Study Completion

August 1, 2007

Last Updated

September 28, 2007

Record last verified: 2007-09

Locations

CH(1)