NCT00805311
Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis
The trial's own stop reason says it succeeded, but ClinicalTrials.gov shows no posted results — flagged as a possible orphaned finding.
- Phase
- PHASE4
- Enrollment
- 400
- Sponsor class
- OTHER
- Taxonomy code
- goal_met
Registry text preserved in the import
“Due to the clear advantage of carotid endarterectomy”
Original pilot evidence — reproduced verbatim
This is the AMTEC trial (Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis). Its result WAS published, just never posted as structured "Results" on CT.gov: Kolos I, Troitskiy A, Balakhonova T, et al; AMTEC Study Group. "Modern medical treatment with or without carotid endarterectomy for severe asymptomatic carotid atherosclerosis." J Vasc Surg. 2015 Oct;62(4):914-922. PMID: 26410046. https://pubmed.ncbi.nlm.nih.gov/26410046/ (full text also at https://www.jvascsurg.org/article/S0741521415010824/pdf) The paper explicitly cites trial registration NCT00805311, three Russian centers, and describes the exact same stop reason as the CT.gov record: the trial was halted early after a median 3.3-year follow-up because of clear superiority of carotid endarterectomy (CEA) added to modern medical treatment (MMT) over MMT alone — 3.3-year cumulative primary event rate 6.5% (CEA) vs 37.5% (MMT), HR 5.06; secondary endpoint 12.9% vs 50.0%. Conclusion: CEA as initial strategy reduces death/major cerebrovascular events vs MMT alone in severe (70-79%) asymptomatic carotid stenosis. One data discrepancy worth flagging: the CT.gov record in the dataset lists enrollment=400 (type ACTUAL), but the published paper reports only 55 patients actually randomized (31 CEA+MMT, 24 MMT alone) between 2009-2013 before the trial was stopped early for benefit — 400 was almost certainly the originally planned/target enrollment that never carried over to an updated "actual" field, not a second larger unpublished trial. All identifying details (NCT ID, sponsor description, exact stop-reason language, condition, phase 4 design) match the published AMTEC study, so this is confidently the same trial, just with its journal publication never linked back into the CT.gov record.
Original search & fetch trail
WebSearch: "NCT00805311 carotid endarterectomy asymptomatic stenosis Russian"; WebSearch: '"Aggressive Medical Treatment" "Asymptomatic Carotid Artery Stenosis" trial Russian Cardiology'; WebFetch on PubMed abstract for PMID 26410046 (confirmed NCT00805311 registration and matching stop reason); WebFetch attempted on clinicaltrials.gov/study/NCT00805311 (returned only nav chrome, no content, but search-result answer box already corroborated title, sponsor, and stop reason).