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NCT00421252 · ClinicalTrials.gov registry record · Phase 4
Role of Plavix in Hemorrhagic and Ischemic Complications of Catheterization.
A Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 18
- Enrollment target
NCT00421252 is a Phase 4 study that was terminated before completion, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 18 participants.
The verdict
NCT00421252, a Phase 4 study, was terminated before completion, sponsored by Beth Israel Deaconess Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 18 participants
- Enrollment target
Study 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 b
Interventions
- DRUG clopidogrel 600 mg
- DEVICE arterial access sheath
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00421252
The ClinicalTrials.gov registry entry for NCT00421252 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which clopidogrel 600 mg is the first listed.
NCT00421252 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00421252 about?
NCT00421252 is a clinical study titled "Role of Plavix in Hemorrhagic and Ischemic Complications of Catheterization.". 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 ar...
What is the current status of trial NCT00421252?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 18 participants. The study started on 2007-01. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00421252?
The interventions under investigation include: clopidogrel 600 mg (DRUG), arterial access sheath (DEVICE).
Who is sponsoring clinical trial NCT00421252?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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