Role of Plavix in Hemorrhagic and Ischemic Complications of Catheterization.

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00421252
• Date of registration: 10/01/2007
• Primary sponsor: Beth Israel Deaconess Medical Center
• Public title: Role of Plavix in Hemorrhagic and Ischemic Complications of Catheterization.
• Scientific title: Impact of Pre-Treatment With 600mg of Clopidogrel (Plavix) on the Incidence of Ischemic and Hemorrhagic Complications in Patients Undergoing Elective Percutaneous Coronary Revascularization.--Prospective Randomized Trial.
• Date of first enrolment: January 2007
• Target sample size: 600
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT00421252
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Joseph P Carrozza, MD

• Name: Joseph P Carrozza, MD
• Affiliation: Beth Israel Deaconess Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patient less than 18 years of age

2. Patient referred as an outpatient for elective cardiac catheterization with coronary
angiography and ad hoc percutaneous coronary intervention (if coronary anatomy
suitable)

3. Patient has stable angina or a stress test suggestive of ischemia and/or prior
myocardial infarction

4. Anticipated femoral arterial approach for the cardiac catheterization procedure

5. Patient provides written informed consent

Exclusion Criteria:

Patients will be excluded if any of the following are present:

1. Use of clopidogrel or ticlopidine during the 14 days prior to the scheduled procedure

2. Known hypersensitivity to clopidogrel (regardless of desensitization) or to any other
components of Plavix

3. Contraindication to clopidogrel, including

1. Pre-existing bleeding disorder or hematological dyscrasia

2. INR >1.4 immediately prior to the scheduled procedure

3. Platelet count <50 K/uL

4. Significant bleeding during the 14 days prior to the scheduled procedure

5. Surgery or invasive procedure at a non-compressible location during the 30 days
prior to the scheduled procedure

6. Anticipated need for surgery or other invasive procedure within 30 days
following the scheduled procedure

7. Patient states unwillingness to undergo transfusion of red blood cells even in
the event of life threatening bleeding

4. Unstable cardiac status

1. Patient was admitted for a cardiac condition and referred as an inpatient for
cardiac catheterization

2. Myocardial infarction diagnosed as occurring during the 30 days prior to the
scheduled procedure

3. Pre-procedure troponin-T >0.01 ng/mL

4. 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

5. Chronic renal failure (which may raise troponin-T levels)

1. Patient currently undergoing dialysis

2. Serum creatinine >2 mg/dL

3. Estimated glomerular filtratation rate (eGFR using the MDRD formula) <45
mL/min/1.73 m2

6. Procedural factors

1. Patient does not require coronary angiography as part of the scheduled cardiac
catheterization

2. Patient is not a candidate for percutaneous coronary intervention during the
same procedure as the diagnostic coronary angiography

3. Anticipated need for arterial access using brachial, radial or other non-femoral
approach

4. Anticipated need to access the femoral artery via a femoral bypass graft

5. Anticipated need for an arterial sheath 6 French in size or larger (e.g.,
planned evaluation of aortic stenosis or hypertrophic cardiomyopathy)

6. 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)

7. Woman of child-bearing potential who does not have a negative pregnancy test
immediately prior to the scheduled procedure

8. 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)

9. Prior participation in this study

10. Inability to provide written informed consent or demonstrate understanding of the
risks and benefits associated with participation in this study



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Bleeding

Coronary Artery Disease

Myocardial Ischemia

Intervention(s)

Drug: clopidogrel 600 mg

Primary Outcome(s)

All cause mortality

All endpoints will be assessed at 14 days post-procedure (and divided for analytical purposes into in-hospital and post-discharge events). The events of interest include:

Angiographically documented stent thrombosis

Any bleeding requiring transfusion of packed RBCs

Aprotonin use in patients requiring urgent cardiac surgery.

Arteriovenous (AV) fistula documented on imaging study or on surgical exploration

Clinically driven repeat revascularization of the target vessel

Fall in hemoglobin by >3 g/dL from the most recent pre-procedure hemoglobin value

Intracranial hemorrhage documented on an imaging study

Myocardial infarction (American College of Cardiology National Cardiovascular Data Registry CathPCI Registry definition of CKMB >3 times the upper limit of normal, i.e. >30 ng/mL)

Myocardial necrosis (troponin-T above the limit diagnostic for myocardial necrosis/infarction, i.e., >0.10 ng/mL)

Pseudoaneurysm documented on imaging study or on surgical exploration

Retroperitoneal hemorrhage documented on an imaging study or on surgical exploration

Vascular injury requiring vascular surgery and/or ultrasound guided therapy (including compression and/or thrombin injection)

Secondary Outcome(s)

Clinical stent thrombosis, which includes angiographically documented stent thrombosis, any acute coronary syndrome post-PCI that cannot be attributed to a non-target vessel, or any cardiac death in which angiographic stent thrombosis cannot be exclude

Composite endpoints to be evaluated include:

Composite TIMI bleeding endpoint: hemoglobin drop >3 g/dL, RBC transfusion, or intracranial hemorrhage

Composite vascular complications endpoint: retroperitoneal bleeding, pseudoaneurysm, AV fistula, or vascular injury requiring vascular surgery or ultrasound guided therapy

The primary composite endpoint of any death, myocardial infarction, or myocardial necrosis

Secondary ID(s)

2006P-000416

Source(s) of Monetary Support

Please refer to primary and secondary sponsors