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NCT01609842 · ClinicalTrials.gov registry record · NA
Hybrid Effectiveness-Implementation Study to Improve Clopidogrel Adherence
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 14,573
- Enrollment target
NCT01609842: Completed NA study, sponsored by VA Office of Research and Development.
NCT01609842 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 14,573 participants, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (939% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01609842, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 14,573 participants
- Enrollment target
Study Summary
Percutaneous coronary intervention (PCI) is a common invasive cardiovascular procedure performed in the VA with over 13,000 procedures in FY10. Clopidogrel is a critical adjuvant therapy following PCI with stent placement and is generally recommended for up to 1 year following the procedure. Despite the evidence supporting clopidogrel use, studies both outside and within the VA suggest that poor adherence to clopidogrel is common. However, prior interventions targeting non-adherence have not specifically focused on clopidogrel adherence among PCI patients. There are many potential reasons for early clopidogrel discontinuation that involve patient and healthcare system factors. Patients reported the following reasons for discontinuing clopidogrel within 1 month after drug-eluting stent (DES) implantation: 1) misunderstanding the intended treatment duration; 2) conflicting recommendations about intended duration; 3) cost of the medication; and 4) patients' own decision to stop. In contrast, patients who continued to take clopidogrel reported the following as helpful: 1) communication such as letters from their physician; and 2) receiving specific instructions on clopidogrel use. These findings suggest that there are specific interventions that can be implemented to improve clopidogrel adherence. Multi-modal interventions that incorporate frequent follow-up, especially with pharmacists and use interactive voice response (IVR) technology have improved medication adherence. IVR technology is a computer-based telephone system which initiates calls, receives calls, provides information, and collects data from users. IVR is currently a mainstay in the VA where patients frequently interact with these automated systems to get clinic appointments and/or refill prescriptions. IVR as part of multi-modal interventions have been well received by patients, increased adherence to medications (e.g., statins), and improved clinical outcomes (e.g., blood pressure, diabetes symptoms,
Primary Outcome
Percentage of patients whose clopidogrel prescription is filled at hospital discharge following the PCI stent placement as well as the percentage of patients who are adherent based on the pharmacy refill data in the year after hospital discharge. We used mixed logistic regression models for clopidogrel adherence (y/n PDC \> 80%) as planned.
Interventions
- OTHER Multifaceted Intervention with pharmacist and IVR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14,573 participants |
| Start Date | 2014-01-20 |
| Est. Completion | 2022-02-07 |
| Phase | NA |
What the finished NCT01609842 record still lists
NCT01609842 is an interventional study that assigns participants to a tested intervention. Its 14,573 participants enrollment target places it among the larger protocols in the corpus, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (939% higher).
The record links to 0 conditions, and to 1 intervention - of which Multifaceted Intervention with pharmacist and IVR is the first listed.
NCT01609842 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01609842 about?
NCT01609842 is a clinical study titled "Hybrid Effectiveness-Implementation Study to Improve Clopidogrel Adherence". Percutaneous coronary intervention (PCI) is a common invasive cardiovascular procedure performed in the VA with over 13,000 procedures in FY10. Clopidogrel is a critical adjuvant therapy following PCI with stent placement and is generally recommended for up to 1 year following the procedure. Despite...
What is the current status of trial NCT01609842?
This trial is currently completed. It is a NA study. The enrollment target is 14,573 participants. The study started on 2014-01-20. Estimated completion is 2022-02-07.
What interventions are being tested in trial NCT01609842?
The interventions under investigation include: Multifaceted Intervention with pharmacist and IVR (OTHER).
Who is sponsoring clinical trial NCT01609842?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01609842's enrollment target sits among peer trials
14,573 13th of 2000 higher than 1,988 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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