Status:
COMPLETED
PAR Regulation of Platelet Function in Diabetic Patients
Lead Sponsor:
Vanderbilt University
Conditions:
Coronary Artery Disease
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
Thrombin is the most potent activator of platelets, and platelet activation is a hallmark of thrombosis. Coronary artery disease (CAD) is the major cause of mortality and morbidity in the United State...
Detailed Description
Given the known roles of proteases and PARs in coagulation, inflammation, pain, healing and protection, the need for development of a PAR antagonist as a therapeutic agent for treatment of thrombosis,...
Eligibility Criteria
Inclusion
- Age: over 18, Sex: male and female.
- Patients who undergo clinically indicated coronary angiography and/or PCI. Patients in Group 1 (elective PCI) include those presented with stable angina (ACC definition for stable angina).
- Coronary angiography reveals severe stenosis (\>70%) that requires PCI.
- Patients in Group 2 (elective PCI in subjects with diabetes) include those who present with stable angina, or with findings on non-invasive testing (exercise or pharmacologic stimulation with imaging by nuclear perfusion imaging or stress echocardiography) in whom coronary angiography reveals severe stenosis (\>70%) that requires PCI.
- Patients in Group 2 (ACS) include those presented with unstable angina or non-ST elevation myocardial infarction (as defined by the ACC).
- Coronary angiography reveals severe stenosis (\>70%) that requires PCI.
Exclusion
- Significant left main coronary artery disease.
- Severely impaired left ventricular systolic function (EF\<35%).
- Prior treatment with enoxaparin, Bivalirudin (or other thrombin inhibitors), Warfarin, or thrombolytic agents \<48 hours. Prior history of myocardial infarction (\<6 weeks).
- Prior history of stroke (\<6 weeks).
- Prior history of coronary intervention (\<6 weeks).
- History of HIV/AIDS.
- The patients will be identified in the following manner:
- All subjects will be picked from a pool of patients diagnosed with stable angina and diabetes from the Vanderbilt Page-Campbell Heart Institute at Vanderbilt University Medical Center and undergo a complete history and physical examination. Patients with acute coronary syndrome will be referred from the acute cardiology patient service at Vanderbilt University Medical Center.
- Subjects with hematologic, renal (creatinine \> 2.0 mg/dl), hepatic, inflammatory, and neoplastic disorders, and those who sustained a recent (\< 1 month) myocardial infarction, ACS, or stroke will be excluded.
- Patients who used nonsteroidal anti-inflammatory drugs, corticosteroids, or hormone replacement therapy will also be excluded.
- Pregnancy will be excluded in women of child bearing potential by measurement of urine ß-HCG (it is standard of care to determine if a woman is pregnant prior to elective PCI and will be screened as part of their PHI).
- For healthy volunteers, pregnancy will be excluded per verbal report.
- Data will be collected regarding patient demographics including height and weight, abdominal circumference, blood pressure, comorbid medical conditions, triglycerides, HDL, fasting glucose and medication use (including prescription of antithrombotic agents, ACE inhibitors, angiotensin receptor blockers, beta blockers, calcium channel antagonists and HMG-CoA inhibitors).
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT00855374
Start Date
June 1 2008
End Date
June 1 2013
Last Update
April 11 2017
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232