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NCT06159231 · ClinicalTrials.gov registry record
FAME II-10-year Follow-Up
A clinical trial, sponsored by CoreAalst.
- Completed
- Registry status
- 888
- Enrollment target
NCT06159231: Completed study, sponsored by CoreAalst.
NCT06159231 is a clinical trial that has completed, run by CoreAalst. The registered enrollment target is 888 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06159231 has completed, sponsored by CoreAalst.
- COMPLETED
- Registry status
- 888 participants
- Enrollment target
Study Summary
The FAME-II trial was a prospective, multicenter, multinational, multi-continental, randomized clinical trial with an 'all comers' design. The overall purpose of the FAME-II trial was to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease and in whom both PCI and medical treatment can be considered on the basis of the presently existing scientific evidence. FAME-II was conducted from 2009 to 2012 and 1-year, 2-year and 5-year results have been published. The purpose of this 10-Year Follow-up is to evaluate the 10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization). Patients will have to sign a specific informed consent for the present 10-year follow-up. This study will be conducted for about approximately 6 months.
Primary Outcome
10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 888 participants |
| Start Date | 2023-04-25 |
| Est. Completion | 2024-05-15 |
What the finished NCT06159231 record still lists
NCT06159231 is an observational study that tracks outcomes without assigning an intervention. The registered 888 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT06159231 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06159231 about?
NCT06159231 is a clinical study titled "FAME II-10-year Follow-Up". The FAME-II trial was a prospective, multicenter, multinational, multi-continental, randomized clinical trial with an 'all comers' design. The overall purpose of the FAME-II trial was to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (O...
What is the current status of trial NCT06159231?
This trial is currently completed. The enrollment target is 888 participants. The study started on 2023-04-25. Estimated completion is 2024-05-15.
Who is sponsoring clinical trial NCT06159231?
This trial is sponsored by CoreAalst, which has 2 total clinical trials registered on ClinicalTrials.gov.
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