Aspirin Responsiveness in Women With Coronary Artery Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT01406990
First received: July 13, 2011
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to measure the percentage of women with known Coronary Artery Disease (CAD) who are hyporesponsive to low dose (81 mg) aspirin.


Condition
CAD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aspirin Responsiveness in Women With Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Women With Known CAD Who Are Hyporesponsive to Low Dose (81 mg) Aspirin [ Time Frame: Time of enrollment ] [ Designated as safety issue: No ]
    Hyporesponsive was defined as Aspirin Response Unit (ARU) > 550 equating to less than 50% platelet inhibition.


Enrollment: 15
Study Start Date: June 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Aspirin 81 mg
Women with CAD taking 81 mg aspirin.

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women between 45 and 85 years of age with known CAD on low dose Aspirin (81 mg) seen at the Cardiac Center of Creighton University

Criteria

Inclusion Criteria:

  • Able and willing to provide informed consent
  • Women at least 45 years old of any race
  • Taking 81 mg aspirin daily, for at least one month
  • Diagnosed with known or suspected CAD with at least one of the following: angiographic evidence of at least one lesion > 50% stenosis, history of significant elevation of biomarker troponin or CK-MB, or history of ECG changes in at least 2 contiguous leads characterized by either new ST depression > 0.1 mV or transient (<30 min) ST elevation > 0.1 mV, coronary artery revascularization either by PCI or CABG

Exclusion Criteria:

  • < 45 years or > 85 years of age
  • Clinically unstable: hypotension defined as sustained systolic blood pressure of <90 mmHg due to cardiac failure with associated symptoms, unstable or severe pulmonary edema, decompensated congestive heart failure, acute mitral regurgitation, acute ventricular septal defect, acute cerebrovascular event or transient ischemic attack (TIA) within the past six months, history of ventricular fibrillation and no implantable cardioverter defibrillator (ICD), sustained supraventricular tachycardia > 30 seconds or associated with symptoms and no ICD, untreated complete heart block or untreated high grade secondary heart block
  • Pregnant, planning to become pregnant, or breastfeeding
  • Alcohol abuse or illicit drug abuse
  • Allergy or intolerance to salicylates and/or excipients including a history of and/or active GI bleed
  • Use of NSAIDs within seven days or planned regular use during the study
  • Taking HRT or oral contraceptives within the past 30 days or planned use during study
  • Use of heparin, warfarin, ADP inhibitors (clopidogrel, prasugrel, or ticlopidine), or glycoprotein IIb/IIa inhibitors within previous 96 hours or planned use during the study
  • Use or planned use of any other medications known to interfere with AA-induced platelet function
  • Currently participating in another investigational drug or device study
  • Survival less than six 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: NCT01406990

Locations
United States, Nebraska
The Cardiac Center at Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Katie Packard, PharmD Creighton University
  More Information

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01406990     History of Changes
Other Study ID Numbers: 11-16154
Study First Received: July 13, 2011
Results First Received: August 28, 2012
Last Updated: August 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
aspirin resistance
hyporesponsive
CAD
women

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
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 15, 2014