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NCT01121224 · ClinicalTrials.gov registry record · Phase 4
Drug-Eluting Stents vs. Bare Metal Stents In Saphenous Vein Graft Angioplasty
A Phase 4 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 4
- Development phase
- 597
- Enrollment target
NCT01121224: Completed Phase 4 study, sponsored by VA Office of Research and Development.
NCT01121224 is a Phase 4 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 597 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01121224, a Phase 4 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 597 participants
- Enrollment target
Study Summary
Patients who have undergone coronary bypass surgery have had a vein removed from the leg and implanted in the chest to "bypass" blockages in the coronary arteries. These veins are called saphenous vein grafts or SVGs. SVGs often develop blockages that can cause chest pain and heart attacks. SVG blockages can be opened by using small balloons and stents (metal coils that keep the artery open). Two types of stents are currently used: bare metal stents (BMS) and drug-eluting stents (DES). Both BMS and DES are made of metal. DES are also coated with a drug that releases into the wall of the blood vessel to prevent scar tissue from forming and re-narrowing the vessel. Both stents have advantages and disadvantages: DES require taking special blood thinners (called thienopyridines, such as clopidogrel or prasugrel) longer than bare metal stent and could have more bleeding but are also less likely to renarrow. Both BMS and DES are routinely being used in SVGs, but it is not known which one is better. Neither bare metal (except for an outdated model) nor drug-eluting stents are FDA approved for use in SVGs. The purpose of CSP#571 is to compare the outcomes after DES vs. BMS use in SVGs. In CSP#571 patients who need stenting of SVG blockages will be randomized to receive DES or BMS in a 1:1 ratio. Per standard practice, patients will receive 12 months of an open label thienopyridine if they have acute coronary syndrome (ACS), or if they have another clinical reason for needing the medication. Patients without ACS who receive DES also need to take 12 months of a thienopyridine whether or not they are in the study, but non-ACS patients who receive a BMS do not. In order to make sure patients do not know which stent they received, non-ACS patients who received BMS will receive 1 month of open label thienopyridine followed by 11 months of blinded placebo, while those who received DES will receive 1 month of open label thienopyridine followed by 11 months of blinded clopidogrel,
Interventions
- DRUG Placebo
- DEVICE Bare Metal Stent
- DEVICE Drug-Eluting Stent
- DRUG Blinded clopidogrel
- DRUG Thienopyridine (open-label)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 597 participants |
| Start Date | 2012-01-11 |
| Est. Completion | 2016-12-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01121224
The ClinicalTrials.gov registry entry for NCT01121224 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 597 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01121224 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01121224 about?
NCT01121224 is a clinical study titled "Drug-Eluting Stents vs. Bare Metal Stents In Saphenous Vein Graft Angioplasty". Patients who have undergone coronary bypass surgery have had a vein removed from the leg and implanted in the chest to "bypass" blockages in the coronary arteries. These veins are called saphenous vein grafts or SVGs. SVGs often develop blockages that can cause chest pain and heart attacks. SVG bloc...
What is the current status of trial NCT01121224?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 597 participants. The study started on 2012-01-11. Estimated completion is 2016-12-31.
What interventions are being tested in trial NCT01121224?
The interventions under investigation include: Placebo (DRUG), Bare Metal Stent (DEVICE), Drug-Eluting Stent (DEVICE), Blinded clopidogrel (DRUG), Thienopyridine (open-label) (DRUG).
Who is sponsoring clinical trial NCT01121224?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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