Aspirin Responsiveness in Women With Coronary Artery Disease

CAD Clinical Trial

Official title:

Aspirin Responsiveness in Women With Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406990
• Other study ID #: 11-16154
• Status: Completed
• Phase: N/A
• First received: July 13, 2011
• Last updated: August 28, 2012
• Start date: June 2011
• Est. completion date: April 2012

Study information

• Verified date: August 2012
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• CAD
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	The Cardiac Center at Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Women With Known CAD Who Are Hyporesponsive to Low Dose (81 mg) Aspirin	Hyporesponsive was defined as Aspirin Response Unit (ARU) > 550 equating to less than 50% platelet inhibition.	Time of enrollment	No