Mechanism Based Resistance to Aspirin

This study has been completed.
Sponsor:
Collaborators:
Bayer
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00948987
First received: July 29, 2009
Last updated: October 14, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Aspirin Resistance
Pharmacological Aspirin Non-responsiveness
Drug: Aspirin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mechanism Based Resistance to Aspirin

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Arachidonic acid induced platelet aggregation [ Time Frame: 8 hours postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum thromboxane B2 concentration Urinary 11-dehydro thromboxane B2 concentration Urinary 2,3 dinor-6 keto PGF1α concentration [ Time Frame: 8 hours postdose ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: September 2004
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aspirin
single dose of aspirin 325 mg p.o.
Drug: Aspirin
325 mg enteric coated single dose p.o.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948987

Sponsors and Collaborators
University of Pennsylvania
Bayer
Investigators
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
  More Information

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Garret A. FitzGerald, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00948987     History of Changes
Other Study ID Numbers: 801907, 0926
Study First Received: July 29, 2009
Last Updated: October 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
aspirin resistance
cardiovascular risk
prostaglandins
platelet inhibition

Additional relevant MeSH terms:
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 14, 2014