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Trial record 5 of 88 for:    ASPIRIN AND thromboxane

Aspirin Resistance in Coronary Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00753935
Recruitment Status : Completed
First Posted : September 17, 2008
Results First Posted : April 19, 2018
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
John Oates, Vanderbilt University

Tracking Information
First Submitted Date  ICMJE September 15, 2008
First Posted Date  ICMJE September 17, 2008
Results First Submitted Date  ICMJE April 7, 2017
Results First Posted Date  ICMJE April 19, 2018
Last Update Posted Date April 19, 2018
Study Start Date  ICMJE June 2006
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2018)
Change in Serum Thromboxane B2 [ Time Frame: after 2 weeks on aspirin ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2008)
Serum thromboxane B2 [ Time Frame: after 2 weeks of aspirin ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aspirin Resistance in Coronary Artery Disease
Official Title  ICMJE Evaluation of Aspirin Resistance at a Molecular Level in Aspirin-Treated Patients With Coronary Artery Disease
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.
Detailed Description

Aspirin is commonly used for its antithrombotic effects in patients at risk for cardiovascular events. Its primary mechanism of action is the irreversible acetylation of platelet cyclooxygenase-1, thereby inhibiting platelet production of thromboxane A2, a potent vasoconstrictor and activator of platelets. 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.

Previous studies have demonstrated that many patients have recurrent events despite treatment with aspirin, which has been termed "aspirin resistance" or "aspirin nonresponse." This study addresses some of the possible mechanisms for aspirin nonresponse; specifically, we will test the hypothesis that aspirin nonresponse results from states that produce high peroxide concentrations ("oxidative stress") in platelets. In addition, we will evaluate the effect of enteric coating on the pharmacologic efficacy of aspirin in patients with coronary artery disease.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Drug: enteric-coated aspirin
    enteric-coated aspirin 81mg daily for 2 weeks
    Other Name: acetylsalicylic acid
  • Drug: Chewable aspirin
    chewable aspirin 81mg daily for 2 weeks
    Other Name: acetylsalicylic acid
Study Arms  ICMJE
  • Experimental: Enteric-coated aspirin
    patients received enteric-coated aspirin 81 mg qd for 2 weeks
    Intervention: Drug: enteric-coated aspirin
  • Active Comparator: Chewable aspirin
    Patients received chewable aspirin 81 mg qd for 2 weeks
    Intervention: Drug: Chewable aspirin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2018)
92
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2008)
160
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00753935
Other Study ID Numbers  ICMJE 040065
5P50HL081009-03 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Oates, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Mary B Taylor, MD, MSCI Vanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP