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Completed

NCT Number: NCT01406990

Aspirin Responsiveness in Women With Coronary Artery Disease

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.

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Key information

Conditions

CAD

Age range

45 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

The Cardiac Center at Creighton University

Omaha, Nebraska, 68131, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Women With Known CAD Who Are Hyporesponsive to Low Dose (81 mg) Aspirin

    Time frame: Time of enrollment

    Hyporesponsive was defined as Aspirin Response Unit (ARU) > 550 equating to less than 50% platelet inhibition.

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 1, 2011
Registry last updated
Sep 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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