Role of Plavix in Hemorrhagic and Ischemic Complications of Catheterization.
Status:
Terminated
Trial end date:
2008-01-01
Target enrollment:
Participant gender:
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 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.