Loss of Effect of Aspirin on Platelet Aggregation During Chronic Administration

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2011-02-28

Brief Summary

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Aspirin has shown to be beneficial to some patients with certain diseases such as coronary artery disease or stroke. We are investigating how aspirin works on regulating platelets and thromboxane over time at different doses. We hope to find the best dose of aspirin and/or other medications to help people who are at risk for heart attack or stroke.

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Detailed Description

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he purpose of the study is to better understand the mechanism for failure of daily aspirin administration to prevent cardiovascular events in some at risk individuals. We seek to describe the effect of chronic aspirin administration at varying doses on platelet aggregation. This will help to define mechanisms for aspirin failure and to pursue possible alternative therapies in patients who fail to respond to aspirin therapy.

We hypothesize that (1) inhibition by aspirin (ASA) of ex vivo-induced platelet aggregation varies in a predictable time and dose dependent manner, (2) thromboxane and prostacyclin production is inhibited by ASA in a dose-dependent manner and remains relatively constant over time once maximal inhibition has occurred, and (3) granule secretion by platelets during induced aggregation is inhibited by aspirin acutely but this effect does not persist during chronic administration at high doses.

Conditions

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Platelet Aggregation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

ASA 40mg daily for 8 weeks followed by 3 weeks of observation

Group Type EXPERIMENTAL

aspirin

Intervention Type DRUG

40mg aspirin: one 40-mg aspirin capsule by mouth each morning + one Avicel capsule by mouth each evening

2

ASA 1300mg daily for 8 weeks followed by 3 weeks of observation

Group Type EXPERIMENTAL

aspirin

Intervention Type DRUG

1300mg aspirin: one 650-mg capsule by mouth twice daily

3

Placebo: one Avicel (cellulose) capsule by mouth twice daily

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo: one Avicel (cellulose) capsule by mouth twice daily

Interventions

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aspirin

40mg aspirin: one 40-mg aspirin capsule by mouth each morning + one Avicel capsule by mouth each evening

Intervention Type DRUG

aspirin

1300mg aspirin: one 650-mg capsule by mouth twice daily

Intervention Type DRUG

placebo

Placebo: one Avicel (cellulose) capsule by mouth twice daily

Intervention Type DRUG

Other Intervention Names

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acetylsalicylic acid ASA acetylsalicylic acid ASA Avicel cellulose

Eligibility Criteria

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Inclusion Criteria

* Males
* Age 18-40 years
* Non-smokers

Exclusion Criteria

* ASA/NSAID use previous 14 days.
* Evidence of ASA/NSAID use within previous 14 days at baseline visit based on investigator interpretation of platelet aggregation and platelet secretion studies.
* History of chronic NSAID use.
* Currently taking NSAIDs, corticosteroids, or anticoagulants.
* History of coronary artery disease, myocardial infarction, coronary artery bypass grafting, percutaneous angioplasty, diabetes mellitus or stroke.
* History of gastric,duodenal, or esophageal ulcers or serious gastrointestinal bleed.
* History of frequent headaches, pain syndrome, or other condition requiring frequent use of analgesics.
* History of adverse reaction to ASA.
* Initial platelet count \<100K/µl or \>500K/µl.
* Initial hematocrit \<35% or \>50%.
* Weight less than 110 pounds.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes