NCT00753935

Brief Summary

The purpose of this study is to evaluate possible mechanisms of aspirin resistance at a molecular level in aspirin-treated patients with coronary artery disease. We hypothesize that certain patient characteristics associate with aspirin resistance. In addition, we will compare the effects of enteric-coated aspirin and chewable aspirin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P75+ for early_phase_1 coronary-artery-disease

Timeline
Completed

Started Jun 2006

Longer than P75 for early_phase_1 coronary-artery-disease

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

April 19, 2018

Completed
Last Updated

April 19, 2018

Status Verified

March 1, 2018

Enrollment Period

5.2 years

First QC Date

September 15, 2008

Results QC Date

April 7, 2017

Last Update Submit

March 19, 2018

Conditions

Coronary Artery Disease

Keywords

aspirinaspirin resistanceaspirin nonresponsecyclooxygenasethromboxaneoxidative stress

Outcome Measures

Primary Outcomes (1)

  • Change in Serum Thromboxane B2

    Thromboxane A2, the major product of cyclooxygenase cytochrome oxidase (COX-1) in platelets, induces platelet aggregation. Thromboxane B2 is an inactive metabolite/product of thromboxane A2. This primary outcome measures the extent of inhibition of platelet COX-1 by measuring the amount of the metabolite thromboxane B2 in serum.

    after 2 weeks on aspirin

Study Arms (2)

Enteric-coated aspirin

EXPERIMENTAL

patients received enteric-coated aspirin 81 mg qd for 2 weeks

Drug: enteric-coated aspirin

Chewable aspirin

ACTIVE COMPARATOR

Patients received chewable aspirin 81 mg qd for 2 weeks

Drug: Chewable aspirin

Interventions

enteric-coated aspirinDRUG

enteric-coated aspirin 81mg daily for 2 weeks

Also known as: acetylsalicylic acid
Enteric-coated aspirin
Chewable aspirinDRUG

chewable aspirin 81mg daily for 2 weeks

Also known as: acetylsalicylic acid
Chewable aspirin

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • On aspirin 81-325mg daily at time of enrollment
  • Documented stable coronary artery disease or \> 6 months after coronary artery bypass grafting or interventional cardiac procedure
  • Written informed consent

You may not qualify if:

  • Pre-menopausal female
  • Renal disease (creatinine \>= 2 mg/dl)
  • Anemia (Hematocrit \< 30%)
  • Thrombocytopenia (platelet count \< 135,000/ul)
  • Use of NSAIDs or coxibs within the previous 2 weeks
  • Concurrent use of other anti-platelet agents
  • Uncontrolled hypertension (systolic BP \> 180 mmHg)
  • Decompensated congestive heart failure
  • Recent coronary syndrome (\< 6 months)
  • History of significant GI bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Smith JP, Haddad EV, Taylor MB, Oram D, Blakemore D, Chen Q, Boutaud O, Oates JA. Suboptimal inhibition of platelet cyclooxygenase-1 by aspirin in metabolic syndrome. Hypertension. 2012 Mar;59(3):719-25. doi: 10.1161/HYPERTENSIONAHA.111.181404. Epub 2012 Feb 6.

    PMID: 22311905RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Limitations and Caveats

There are no limitations or caveats.

Results Point of Contact

Title
John A. Oates, MD
Organization
Vanderbilt_University MC
john.oates@vanderbilt.edu
615 4343 4847

Study Officials

  • Mary B Taylor, MD, MSCI

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
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 15, 2008

First Posted

September 17, 2008

Study Start

June 1, 2006

Primary Completion

August 1, 2011

Study Completion

March 1, 2014

Last Updated

April 19, 2018

Results First Posted

April 19, 2018

Record last verified: 2018-03

Locations

US(1)