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
What the registry says
“Due to the clear advantage of carotid endarterectomy”
What real verification found
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the originally planned/target enrollment that never carried over to an updated "actual" field, not a second larger unpublished trial.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.
Full 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).