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| Sponsor: | Beth Israel Deaconess Medical Center |
|---|---|
| Information provided by: | Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT00421252 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease Myocardial Ischemia Bleeding |
Drug: clopidogrel 600 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
| 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. |
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | September 2008 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded if any of the following are present:
Contraindication to clopidogrel, including
Unstable cardiac status
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)
Procedural factors
Contacts and Locations| Contact: Joseph P Carrozza, MD | 617-632-7455 | jcarrozz@bidmc.harvard.edu |
| Contact: Joanna J Wykrzykowska, MD | 617-767-5343 | jwykrzyk@bidmc.harvard.edu |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: | Joseph P Carrozza, MD | Beth Israel Deaconess Medical Center |
More Information
| Study ID Numbers: | 2006P-000416 |
| Study First Received: | January 10, 2007 |
| Last Updated: | March 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00421252 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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clopidogrel hemorrhagic complication vascular complication antiplatelet agent stenting |
percutaneous coronary intervention risk ischemia troponin sheath size |
|
Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Hematologic Agents Vascular Diseases Ischemia Arteriosclerosis Pharmacologic Actions |
Coronary Disease Pathologic Processes Therapeutic Uses Clopidogrel Cardiovascular Diseases Platelet Aggregation Inhibitors Coronary Artery Disease |