Role of Plavix in Hemorrhagic and Ischemic Complications of Catheterization.
Recruitment status was: Not yet recruiting
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 can result in a heart attack. The 2 anti-platelet medications used for most patients with stents are aspirin and clopidogrel (Plavix). These are usually prescribed for 1-12 months (the length of time depends on the number and types of stents implanted). Although the typical long-term dose of clopidogrel is 75 mg by mouth once daily, a larger dose (known as a loading dose) is usually given at the start of treatment to help the medication take effect more quickly.
Prior to January 2006, most patients at the Beth Israel Deaconess Medical Center (BIDMC) who were undergoing PCI and who had not already been taking clopidogrel would receive a loading dose of 300-600 mg of clopidogrel in the cardiac catheterization procedure room immediately after the angioplasty and stenting portion of the procedure. However, several recent studies suggest that administering clopidogrel 600 mg at least two hours prior to an angioplasty procedure can reduce the rate of complications afterwards (especially reducing the chances of detectable damage to the heart muscle).
The main purpose of this study is to see whether giving a loading dose of clopidogrel 600 mg to outpatients scheduled to undergo cardiac catheterization with coronary angiography can decrease the risk of procedure-related complications during the 14 days following the cardiac catheterization compared to a strategy of giving clopidogrel 600 mg after the procedure only to those who undergo angioplasty. We will focus our attention particularly on detecting damage to heart muscle following angioplasty (which might be expected to improve with a loading dose of clopidogrel before the procedure) and on bleeding and other groin complications (which might worsen with clopidogrel loading before the procedure).
The drug clopidogrel has been approved by the Food and Drug Administration (FDA) for use in patients with a recent or ongoing heart attack, narrowings in major blood vessels outside the heart, or recent stroke with a loading dose of 300 mg followed by 75 mg once daily. It has been used in several large studies with a loading dose of 600 mg without a significant increase in major adverse effects. However, we do not yet know if it is useful or safe when given as a loading dose of 600 mg before cardiac catheterization for outpatients with stable symptoms and who are not thought to be in the midst of a heart attack.
Coronary Artery Disease
Drug: clopidogrel 600 mg
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official 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.|
- 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:
- All cause mortality
- 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)
- Clinically driven repeat revascularization of the target vessel
- Angiographically documented stent thrombosis
- Fall in hemoglobin by >3 g/dL from the most recent pre-procedure hemoglobin value
- Any bleeding requiring transfusion of packed RBCs
- Intracranial hemorrhage documented on an imaging study
- Retroperitoneal hemorrhage documented on an imaging study or on surgical exploration
- Pseudoaneurysm documented on imaging study or on surgical exploration
- Arteriovenous (AV) fistula documented on imaging study or on surgical exploration
- Vascular injury requiring vascular surgery and/or ultrasound guided therapy (including compression and/or thrombin injection)
- Aprotonin use in patients requiring urgent cardiac surgery.
- Composite endpoints to be evaluated include:
- The primary composite endpoint of any death, myocardial infarction, or myocardial necrosis
- 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 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
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||September 2008|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421252
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Joseph P Carrozza, MD||Beth Israel Deaconess Medical Center|