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NCT00963781 · ClinicalTrials.gov registry record · Phase 4
Scripps Evaluation of Antiplatelet Therapies for Intermediate Duration With the Endeavor Stent (Seaside)
A Phase 4 study, sponsored by Scripps Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 219
- Enrollment target
NCT00963781: Completed Phase 4 study, sponsored by Scripps Health.
NCT00963781 is a Phase 4 study that has completed, run by Scripps Health. The registered enrollment target is 219 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00963781, a Phase 4 study, has completed, sponsored by Scripps Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 219 participants
- Enrollment target
Study Summary
Despite the benefit of drug-eluting stents (DES) to reduce the need for repeat revascularization procedures, concerns regarding late stent thrombosis (ST) have led to recent guidelines advocating extended prescription of dual antiplatelet therapy (DAPT) with aspirin and a thienopyridine (clopidogrel or ticlopidine\]) beyond that described in the product labeling. Specifically, an advisory has recommended at least 1 year DAPT following treatment with DES in patients without contraindications. However, this recommendation was largely empiric and not based on any trial showing reductions in ST with long-term DAPT, nor are potential safety differences between DES considered. Further, no study has examined the balance in potential efficacy with long-term DAPT relative to an increased bleeding risk. A consistency across clinical trials involving the Endeavor DES has been very low rates of late myocardial infarction, cardiac death and ST. Unlike other DES, recent studies indicate that the Endeavor stent may permit more rapid and complete healing over stent struts in addition to restoring normal blood vessel function. Further, in patients treated with the Endeavor stent, long-term safety outcomes are similar through 3 years follow-up irrespective of whether patients were adherent to DAPT for durations of ≤ 6 months, 12 months or 24 months. In this study, long-term safety and effectiveness will be examined for patients treated with the Endeavor stent and assigned to DAPT for reduced duration of 6 months. If the study demonstrates safety and efficacy, it could influence treatment guidelines in favor of an abbreviated duration of DAPT for patients treated with the Endeavor stent. This would mean that should a bleeding complication or need or surgery arise less than 12 months post-PCI, patients treated with the Endeavor stent could stop DAPT after 6 months with reasonable estimate of safety. Furthermore, it is possible that patients who are currently denied DES due to known n
Interventions
- DEVICE Medtronic Endeavor Stent
- DRUG Reduced duration (6 months) DAPT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2009-08 |
| Est. Completion | 2013-08 |
| Phase | Phase 4 |
What the finished NCT00963781 record still lists
NCT00963781 is an interventional study that assigns participants to a tested intervention. The registered 219 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Medtronic Endeavor Stent is the first listed.
NCT00963781 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00963781 about?
NCT00963781 is a clinical study titled "Scripps Evaluation of Antiplatelet Therapies for Intermediate Duration With the Endeavor Stent (Seaside)". Despite the benefit of drug-eluting stents (DES) to reduce the need for repeat revascularization procedures, concerns regarding late stent thrombosis (ST) have led to recent guidelines advocating extended prescription of dual antiplatelet therapy (DAPT) with aspirin and a thienopyridine (clopidogrel...
What is the current status of trial NCT00963781?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 219 participants. The study started on 2009-08. Estimated completion is 2013-08.
What interventions are being tested in trial NCT00963781?
The interventions under investigation include: Medtronic Endeavor Stent (DEVICE), Reduced duration (6 months) DAPT (DRUG).
Who is sponsoring clinical trial NCT00963781?
This trial is sponsored by Scripps Health, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00963781's enrollment target sits among peer trials
219 389th of 2000 higher than 1,611 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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