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FAVORITE

UnknownPhase 2

Efficacy 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

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

Org study ID2018YFC1312303
NCT IDNCT03891277

Timeline

Milestones

Study first posted2019-03-27actual
Study start2019-04-01actual
Last update posted2020-07-13actual
Primary completion2021-10-31estimated
Study completion2021-12-31estimated

Assets

Drug assets

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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

Other (unclassified)
3
Global cognition
1
Other clinical outcomes
1

Global cognition

1 endpoint
Primary/protocol endpoint

prevalence 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 endpoint
Secondary/protocol endpoint

All-cause death

Time frame:1 year after randomization

descriptive

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Stroke recurrence (including hemorrhagic and ischemic stroke)

Time frame:1 year after randomization

descriptive

Secondary/protocol endpoint/low confidence

Poor functional outcome

Time frame:1 year after randomization

descriptive

Secondary/protocol endpoint/low confidence

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.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.