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FAVORITE
UnknownPhase 2Efficacy and Safety of Ferrous Iron on the Prevention of Vascular Cognitive Impairment Among Patients With Cerebral Infarction/TIA (FAVORITE)
Efficacy and Safety of Ferrous Iron on the Prevention of Vascular Cognitive Impairment Among Patients With Cerebral Infarction/TIA,FAVORITE
Lead sponsor
Asset
Ferrous succinate
Listed sites
1
Recruiting sites
1
Enrollment
1,006
estimated
Study population
Vascular cognitive impairment / dementia
Key I/E criterion
•Age 18-80
Primary endpoint
•Montreal Cognitive Assessment (MoCA)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Age :18-80 years old , male or female;
2. one of the following situations: A.recent ischemic stroke or TIA (within 3 months) B. One or more vascular risk factors including hypertension, diabetes mellitus, or dyslipidemia, with multiply lacunar infarctions(≥2) or extensive white matter lesions(Fazekas ≥2) or multiply microhaemorrhage(≥2) showed on CT/MR.
3. Fe deficiency (serum ferritin<20µg/L)or Hemoglobin deficiency(≥60 g/L and <120g/L for female,or ≥60 g/L and <130g/L for male)
4. Signed informed consent
Exclusion criteria
1. CT/MR showed Intracranial haemorrhage or non-cerebral vascular disease (eg. intracranial tumors, multiple sclerosis);
2. Patients who Can not cooperate with the completion of neuropsychological evaluation for Severe hearing impairment, visual impairment, unilateral neglect, or dyskinesia;
3. Patients with Severe anemia with Hemoglobin<60 g/L;
4. Patients with thalassemia, megaloblastic anemia or erythronoclastic anemia.
5. Patients with Mental illness or schizophrenia;
6. Patients who were diagnosed definitely as Alzheimer's disease;
7. Patients having history of taking drugs including Cholinesterase inhibitors、NMDA antagonists、5-hydroxytryptophan receptor antagonists、pyrrolidone and other definite drugs for improving cognition(e.g. donepezil、Galanthamine、Memantine、huperzine A、oxiracetam、aniracetam、piracetam、butyphthalide) within 3 months before randomization;
8. Patients with severe liver or kidney insufficiency(ALT>twofold upper normal limit or Aspartate Aminotransferase>twofold upper normal limit; Cr>1.5 times upper normal limit or Glomerular Filtration Rate<40 ml/min/1.73m2);
9. Patients with Severe untreated urinary tract infection;
10. Patients with hemochromatosis or hemosiderosis(e.g. Iron lung deposition);
11. Patients with Iron allergy or other contraindications of using Iron;
12. Pregnant or childbearing-age women;
13. Patients who are undergoing experimental drugs or device tests;
14. Patients Unable to finish the follow-up of 3 months or 1 year due to geographical factor or other reasons;
15. Patients or legal representatives refuse to participate.
Endpoints (5)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
1 endpointprevalence of vascular cognitive impairment in patients given Ferrous succinate versus placebo
Time frame:1 year after randomization
Montreal Cognitive Assessment (MoCA)
descriptive
Other clinical outcomes
1 endpointAll-cause death
Time frame:1 year after randomization
descriptive
Other (unclassified)
3 endpointsStroke recurrence (including hemorrhagic and ischemic stroke)
Time frame:1 year after randomization
descriptive
Poor functional outcome
Time frame:1 year after randomization
descriptive
Value of Hemoglobin/serum ferritin/serum Tau/serum Aß
Time frame:3 months and 1 year after randomization
descriptive
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID38789134via DERIVED
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.