Aspirin Responsiveness in Women With Coronary Artery Disease
This study has been completed.
Sponsor:
Creighton University
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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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:
MedlinePlus related topics:
Coronary Artery Disease
Drug Information available for:
Aspirin
U.S. FDA Resources
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
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 June 18, 2013