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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: Clinical Trial Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.

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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

includes death, MI, TVR, stent throbmosis

Interventions

  • DRUG clopidogrel 600 mg
  • DEVICE arterial access sheath

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2007-01
Est. Completion 2008-01
Phase Phase 4

Why NCT00421252 stopped before completion

NCT00421252 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which clopidogrel 600 mg is the first listed.

NCT00421252 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00421252's enrollment target sits among peer trials

18 1842nd of 2000 higher than 147 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00421252, the US trial registry maintained by the National Library of Medicine. NCT00421252 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.