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NCT00344019 · ClinicalTrials.gov registry record · Phase 4
Effects of Atorvastatin on Myonecrosis
A Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 97
- Enrollment target
NCT00344019: Clinical Trial Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.
NCT00344019 is a Phase 4 study that was terminated before completion, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 97 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00344019, a Phase 4 study, was terminated before completion, sponsored by Beth Israel Deaconess Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 97 participants
- Enrollment target
Study Summary
This study is designed as a prospective, randomized, placebo-controlled, double-blind analysis of atorvastatin 80 mg versus placebo administered on average 4 hours prior to percutaneous coronary intervention \[PCI\] (at least 2 hours) in patients presenting with unstable angina. Only patients with negative cardiac biomarkers, measured on 2 separate occasions a few hours apart will be eligible for inclusion. Furthermore, patients already on high-dose statin therapy; patients taking any statin within 24 hours prior to the PCI; and patients with contraindications to statins will be excluded from the study. The primary endpoint is a quantitative troponin level at 18-24 hours after PCI. At an enrollment of a total of 150 patients (75 per group), the study is powered to detect a 30% difference in troponin level. Secondary endpoints include elevation of creatine kinase (CK) and CK-MB above the upper limit of normal, change in C-reactive protein (CRP) levels from baseline and thrombolysis in myocardial infarction (TIMI) myocardial perfusion grade. All patients will be started on statin therapy the day after the procedure, as deemed appropriate by their treating physicians.
Primary Outcome
As measured by troponin T (TnT), during percutaneous coronary intervention (PCI). TnT will be measured at 18-24 hours. Assuming a 40% event rate (elevation in TnT), this study powered to predict 30% relative reduction in TnT
Interventions
- DRUG Atorvastatin 80mg
- DRUG Placebo Oral Tablet
- OTHER Screening
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2006-05 |
| Est. Completion | 2009-01 |
| Phase | Phase 4 |
Why NCT00344019 stopped before completion
NCT00344019 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which Atorvastatin 80mg is the first listed.
NCT00344019 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00344019 about?
NCT00344019 is a clinical study titled "Effects of Atorvastatin on Myonecrosis". This study is designed as a prospective, randomized, placebo-controlled, double-blind analysis of atorvastatin 80 mg versus placebo administered on average 4 hours prior to percutaneous coronary intervention \[PCI\] (at least 2 hours) in patients presenting with unstable angina. Only patients with n...
What is the current status of trial NCT00344019?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 97 participants. The study started on 2006-05. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00344019?
The interventions under investigation include: Atorvastatin 80mg (DRUG), Placebo Oral Tablet (DRUG), Screening (OTHER).
Who is sponsoring clinical trial NCT00344019?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00344019's enrollment target sits among peer trials
97 861st of 2000 higher than 1,138 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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