Platelet Inhibition by Aspirin, Acetaminophen and NSAID - Full Text View

Sponsored by:	Kantonsspital Graubünden
Information provided by:	Kantonsspital Graubünden
ClinicalTrials.gov Identifier:	NCT00536068

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

Drug Information available for: Naproxen Naproxen sodium Acetylsalicylic acid Diclofenac Diclofenac potassium Diclofenac sodium Acetaminophen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study

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
1, 2, 3, 4: 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	Drug: Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placebo Acetylsalicylic acid 100mg/po and acetaminophen 3x1g/po for 4 days Acetylsalicylic acid 100mg/po and diclofenac 3x50mg/po for 4 days Acetylsalicylic acid 100mg/po and naproxen 3x250mg/po for 4 days 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

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

Keywords provided by Kantonsspital Graubünden:

platelet
aggregation
aspirin

Study placed in the following topic categories:

Naproxen
Aspirin
Diclofenac
Acetaminophen

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009