Status:
TERMINATED
Role of Plavix in Hemorrhagic and Ischemic Complications of Catheterization.
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Coronary Artery Disease
Myocardial Ischemia
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
Patients who have stents placed in their coronary arteries require treatment with at least two medications to prevent platelets from sticking to the stainless steel stent and forming a blood clot that...
Detailed Description
SIGNIFICANCE AND BACKGROUND FOR THE STUDY The benefits of dual anti-platelet therapy with full dose aspirin and a thienopyridine have been firmly established in patients undergoing coronary stenting. ...
Eligibility Criteria
Inclusion
- Patient less than 18 years of age
- Patient referred as an outpatient for elective cardiac catheterization with coronary angiography and ad hoc percutaneous coronary intervention (if coronary anatomy suitable)
- Patient has stable angina or a stress test suggestive of ischemia and/or prior myocardial infarction
- Anticipated femoral arterial approach for the cardiac catheterization procedure
- Patient provides written informed consent
Exclusion
- Patients will be excluded if any of the following are present:
- Use of clopidogrel or ticlopidine during the 14 days prior to the scheduled procedure
- Known hypersensitivity to clopidogrel (regardless of desensitization) or to any other components of Plavix
- Contraindication to clopidogrel, including
- Pre-existing bleeding disorder or hematological dyscrasia
- INR \>1.4 immediately prior to the scheduled procedure
- Platelet count \<50 K/uL
- Significant bleeding during the 14 days prior to the scheduled procedure
- Surgery or invasive procedure at a non-compressible location during the 30 days prior to the scheduled procedure
- Anticipated need for surgery or other invasive procedure within 30 days following the scheduled procedure
- Patient states unwillingness to undergo transfusion of red blood cells even in the event of life threatening bleeding
- Unstable cardiac status
- Patient was admitted for a cardiac condition and referred as an inpatient for cardiac catheterization
- Myocardial infarction diagnosed as occurring during the 30 days prior to the scheduled procedure
- Pre-procedure troponin-T \>0.01 ng/mL
- Unstable angina
- i. Ischemic symptoms at rest ii. Ischemic symptoms with mild exertion (e.g., walking one to two level blocks or climbing one flight of stairs) e. Pre-procedure electrocardiogram with ST segment changes indicative of ongoing myocardial injury or ischemia
- Chronic renal failure (which may raise troponin-T levels)
- Patient currently undergoing dialysis
- Serum creatinine \>2 mg/dL
- Estimated glomerular filtratation rate (eGFR using the MDRD formula) \<45 mL/min/1.73 m2
- Procedural factors
- Patient does not require coronary angiography as part of the scheduled cardiac catheterization
- Patient is not a candidate for percutaneous coronary intervention during the same procedure as the diagnostic coronary angiography
- Anticipated need for arterial access using brachial, radial or other non-femoral approach
- Anticipated need to access the femoral artery via a femoral bypass graft
- Anticipated need for an arterial sheath 6 French in size or larger (e.g., planned evaluation of aortic stenosis or hypertrophic cardiomyopathy)
- Anticipated need for heparin anticoagulation during the diagnostic cardiac catheterization procedure (e.g., crossing a stenosed aortic valve with a 0.035" wire, planned intra-vascular ultrasound or pressure wire study)
- Woman of child-bearing potential who does not have a negative pregnancy test immediately prior to the scheduled procedure
- Participation in another non-observational clinical study that has not yet completed all mandatory follow-up (i.e., patients who are participating in a "natural history" observational registry where no active therapy is being investigated may participate)
- Prior participation in this study
- Inability to provide written informed consent or demonstrate understanding of the risks and benefits associated with participation in this study
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00421252
Start Date
January 1 2007
End Date
January 1 2008
Last Update
April 14 2017
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215