Loss of Effect of Aspirin on Platelet Aggregation During Chronic Administration

NCT00748371 | Terminated Phase 4

• 1 other identifier: GM15431-JAO1
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Platelet Aggregation

Keywords

platelet aggregation; granule secretion; thromboxane production; prostacyclin production

Outcome Measures

Primary Outcomes (1)

• Comparison of platelet aggregation, serum thromboxane B2 (TxB2) levels, urinary thromboxane metabolite (Tx-M) levels, and urinary prostacyclin metabolite (PGI-M) levels over time and across dose ranges.

  11 weeks

Study Arms (3)

1

EXPERIMENTAL

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

Drug: aspirin

2

EXPERIMENTAL

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

Drug: aspirin

3

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

aspirin DRUG

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

Also known as: acetylsalicylic acid, ASA

1

placebo DRUG

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

Also known as: Avicel, cellulose

3

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232-6602, United States

Location

MeSH Terms

Interventions

Aspirin; Cellulose

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• John A Oates, M.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Pharmacology

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 8, 2008
• Study Start: June 1, 2004
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 12, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)