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Mechanism Based Resistance to Aspirin

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. Identifier: NCT00948987
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : October 15, 2009
National Institutes of Health (NIH)
Information provided by:
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE July 29, 2009
First Posted Date  ICMJE July 30, 2009
Last Update Posted Date October 15, 2009
Study Start Date  ICMJE September 2004
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2009)
Arachidonic acid induced platelet aggregation [ Time Frame: 8 hours postdose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2009)
Serum thromboxane B2 concentration Urinary 11-dehydro thromboxane B2 concentration Urinary 2,3 dinor-6 keto PGF1α concentration [ Time Frame: 8 hours postdose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Mechanism Based Resistance to Aspirin
Official Title  ICMJE Mechanism Based Resistance to Aspirin
Brief Summary The purpose of this research is to study why some people do not respond to the benefits of aspirin therapy. The benefit of aspirin is cardioprotection, or decreasing the risk of heart attack and/or stroke. Aspirin works by disabling the platelets, part of the blood cells used in clotting, from sticking together and forming blood clots, thus protecting the heart. It has been observed that failure to respond to aspirin therapy occurs in about 10% of the general population and that despite taking aspirin everyday, this group of non- responders is not getting protection for their heart. The investigators would like to determine why and how this happens.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aspirin Resistance
  • Pharmacological Aspirin Non-responsiveness
Intervention  ICMJE Drug: Aspirin
325 mg enteric coated single dose p.o.
Study Arms  ICMJE Experimental: Aspirin
single dose of aspirin 325 mg p.o.
Intervention: Drug: Aspirin
Publications * Grosser T, Fries S, Lawson JA, Kapoor SC, Grant GR, FitzGerald GA. Drug resistance and pseudoresistance: an unintended consequence of enteric coating aspirin. Circulation. 2013 Jan 22;127(3):377-85. doi: 10.1161/CIRCULATIONAHA.112.117283. Epub 2012 Dec 4.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2009)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age between 18 - 55
  • Subjects must be in good health as based on medical history, physical examination, vital signs, and laboratory tests.
  • All subjects must be non- smoking volunteers
  • Female subjects of child bearing potential must be using a medically acceptable method of contraception (oral contraception, depo-provera injection, IUD, condom with spermicide, diaphragm, cervical cap, progestin implant, abstinence, tubal ligation, oophorectomy, TAH) throughout the entire study period. All female subjects must consent to a urine pregnancy test at screening and just prior to the start of each treatment phase of the study, which must be negative at all time points.
  • Subjects must be within 30% of their ideal body weight.

Exclusion Criteria:

  • Female subjects who are pregnant or nursing a child.
  • Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening.
  • Subjects with any coagulation, bleeding or blood disorders.
  • Subjects who are sensitive or allergic to aspirin as well as any of their components.
  • Subjects with documented history of any gastrointestinal disorders, including bleeding ulcers.
  • Subjects with any evidence of cancer.
  • Subjects with a history of heart disease, including myocardial infarction, angina, coronary artery disease, any evidence of coronary artery stenosis, arrhythmias, heart failure, having had a CABG
  • Subjects with renal, hepatic, respiratory, endocrine, metabolic, hematopoietic or neurological disorder.
  • Subjects with any abnormal laboratory value or physical finding that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject.
  • Subjects who have had a history of drug or alcohol abuse within the last 6 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
Administrative Information
NCT Number  ICMJE NCT00948987
Other Study ID Numbers  ICMJE 801907
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Garret A. FitzGerald, University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • Bayer
Investigators  ICMJE
Principal Investigator: Garret A FitzGerald, MD University of Pennsylvania, Institute for Translationals Medicine and Therapeutics
Principal Investigator: Susanne Fries, MD University of Pennsylvania, Institute for Translationals Medicine and Therapeutics
Principal Investigator: Tilo Grosser, MD University of Pennsylvania, Institute for Translationals Medicine and Therapeutics
PRS Account University of Pennsylvania
Verification Date October 2009

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