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NCT00789724 · ClinicalTrials.gov registry record · Phase 3
Anakinra to Prevent Post-infarction Remodeling
A Phase 3 study, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- Phase 3
- Development phase
- 10
- Enrollment target
NCT00789724 is a Phase 3 study that has completed, run by Virginia Commonwealth University. The registered enrollment target is 10 participants.
The verdict
NCT00789724, a Phase 3 study, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 10 participants
- Enrollment target
Study Summary
Thousands of patients die daily from early and late complications of a heart attack (acute myocardial infarction, AMI). Patients surviving AMI remain at high risk of death from adverse cardiac remodeling (dysfunction and enlargement of the heart) leading to heart failure (weakening of the heart). Current interventions proven to reduce adverse remodeling and progression to heart failure include early reperfusion (restoring blood flow to the heart muscle) and long-term use of medicines that block the effects of hormones (such as angiotensin II, norepinephrine and aldosterone) involved in adverse remodeling. Despite these treatments, however, many patients continue to develop heart failure within 1 year of AMI. These patients are at very high risk of death. Numerous changes occur in the hearts of patients after AMI that lead to adverse remodeling. Ischemia (lack of oxygen) and infarction (cell damage) lead to increased interleukin-1 (IL-1) production in the heart. IL-1 plays a critical role in adverse cardiac remodeling by coordinating the inflammatory pathway (leading to wound healing) and apoptotic pathway (leading to cell death). In opposition to IL-1 activity, the human body produces a natural IL-1 receptor antagonist that blocks the effects of IL-1. The drug form of this IL-1 receptor antagonist (anakinra) is currently FDA approved for the treatment of rheumatoid arthritis, an inflammatory disease characterized by excessive IL-1 activity. Experimental studies show that anakinra is able to prevent cardiac remodeling and improve survival in mice after AMI. We hypothesize that anakinra will show similar benefits in human patients by preventing adverse remodeling and heart failure after AMI.
Interventions
- DRUG Placebo
- DRUG Anakinra
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2008-11 |
| Est. Completion | 2009-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00789724
The ClinicalTrials.gov registry entry for NCT00789724 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00789724 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00789724 about?
NCT00789724 is a clinical study titled "Anakinra to Prevent Post-infarction Remodeling". Thousands of patients die daily from early and late complications of a heart attack (acute myocardial infarction, AMI). Patients surviving AMI remain at high risk of death from adverse cardiac remodeling (dysfunction and enlargement of the heart) leading to heart failure (weakening of the heart). C...
What is the current status of trial NCT00789724?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 10 participants. The study started on 2008-11. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00789724?
The interventions under investigation include: Placebo (DRUG), Anakinra (DRUG).
Who is sponsoring clinical trial NCT00789724?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
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