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NCT06159231: FAME2-10yFU
FAME II-10-year Follow-Up
trial in Coronary Artery Disease in 888 participants. Completed in 15 May 2024.
15 May 2024
Quick facts
| Lead sponsor | CoreAalst BV |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 888 |
| Start date | 25 April 2023 |
| Primary completion | 15 May 2024 |
| Estimated completion | 15 May 2024 |
| Sites | 16 locations across Denmark, France, Italy, Netherlands, Belgium, Serbia, Sweden, Germany |
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
Sponsor
CoreAalst BV — full company profile →
Who can join
21 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Fractional flow reserve-guided percutaneous coronary intervention versus medical therapy for stable coronary artery disease: long-term results of the FAME 2 trial.
Collet C, Mahendiran T, Fearon WF, Mizukami T, et al · · 2026 · PMID 41540107 · DOI 10.1038/s41591-025-04132-5
Verify or expand the search:
- PubMed search for NCT06159231
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other CoreAalst BV trials
Trials by the same sponsor.
- NCT06898021 — The 3D Stent Study · recruiting
- NCT06205810 — The COMPLETE Study · recruiting
- NCT05810051 — Exercise and Coronary Microvascular Disease · NA · active not recruiting
- NCT05437900 — INSIGHTFUL-FFR Clinical Trial · Phase 4 · recruiting
- NCT05805462 — The Euro-CRAFT Registry · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06159231 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CoreAalst BV
- Last refreshed: 7 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06159231.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing