NCT03891277

Brief Summary

The prevalence of Vascular Cognitive Impairment(VCI) is high in patients after ischemic stroke or transient ischemic attack(TIA) . Effective therapy for the prevention of VCI remains limited. The primary purpose of this study is to evaluate the efficacy and safety of Ferrous iron versus placebo on the prevention of vascular cognitive impairment among patients with ischemic stroke/TIA complicated with Hemoglobin deficiency.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,006

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

2.6 years

First QC Date

February 25, 2019

Last Update Submit

July 10, 2020

Conditions

Vascular Cognitive ImpairmentDementia, VascularIron-deficiencyCerebral InfarctionTIA

Keywords

Vascular Cognitive Impairmentdementiairon deficiencycerebral infarctionTIAbiological markersClinical Trial

Outcome Measures

Primary Outcomes (1)

  • prevalence of vascular cognitive impairment in patients given Ferrous succinate versus placebo

    Vascular cognitive impairment will be diagnosed with Montreal Cognitive Assessment(MoCA, range 0-30 scores) \<26 scores

    1 year after randomization

Secondary Outcomes (4)

  • All-cause death

    1 year after randomization

  • Stroke recurrence (including hemorrhagic and ischemic stroke)

    1 year after randomization

  • Poor functional outcome

    1 year after randomization

  • Value of Hemoglobin/serum ferritin/serum Tau/serum Aß

    3 months and 1 year after randomization

Study Arms (2)

Ferrous succinate

ACTIVE COMPARATOR

Ferrous succinate sustained-release tablets（Ferrous succinate 0.2g）1 tablet, Qd, po during or after breakfast, Lasting for 12 weeks.

Drug: Ferrous succinate

placebo

PLACEBO COMPARATOR

placebo with almost the same size, color and smell as Ferrous iron will be used with 1 tablet, Qd, po during or after breakfast, Lasting for 12 weeks.

Drug: Ferrous succinate

Interventions

Ferrous succinateDRUG

Ferrous succinate sustained-release tablets（Ferrous succinate 0.2g）1 tablet, Qd,po during or after breakfast, Lasting for 12 weeks. placebo with almost the same size, color and smell as Ferrous iron will be used with 1 tablet, Qd, po during or after breakfast, Lasting for 12 weeks.

Also known as: Placebo
Ferrous succinateplacebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age :18-80 years old , male or female;
  • 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.
  • 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)
  • Signed informed consent.

You may not qualify if:

  • CT/MR showed Intracranial haemorrhage or non-cerebral vascular disease (eg. intracranial tumors, multiple sclerosis);
  • Patients who Can not cooperate with the completion of neuropsychological evaluation for Severe hearing impairment, visual impairment, unilateral neglect, or dyskinesia;
  • Patients with Severe anemia with Hemoglobin\<60 g/L;
  • Patients with thalassemia, megaloblastic anemia or erythronoclastic anemia.
  • Patients with Mental illness or schizophrenia;
  • Patients who were diagnosed definitely as Alzheimer's disease;
  • 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；
  • 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）;
  • Patients with Severe untreated urinary tract infection;
  • Patients with hemochromatosis or hemosiderosis(e.g. Iron lung deposition);
  • Patients with Iron allergy or other contraindications of using Iron；
  • Pregnant or childbearing-age women；
  • Patients who are undergoing experimental drugs or device tests;
  • Patients Unable to finish the follow-up of 3 months or 1 year due to geographical factor or other reasons;
  • Patients or legal representatives refuse to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing tiantan hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Related Publications (1)

  • Jia Q, Lei P, Sun L, Jia WL, Pan Y, Yuan B, Wang Y, Zhou Q, Meng X, Jing J, Lin J, Wang A, Zhang S, Hong Z, Yang Y, Xiong Y, Li Z, Wang Y, Zhao X, Wang Y. Efficacy and safety of Ferrous iron on the prevention of Vascular cOgnitive impaiRment among patients with cerebral Infarction/TIA (FAVORITE): rationale and design of a multicentre randomised trial. Stroke Vasc Neurol. 2025 Feb 25;10(1):136-141. doi: 10.1136/svn-2023-002644.

    PMID: 38789134DERIVED

MeSH Terms

Conditions

Dementia, VascularAnemia, Iron-DeficiencyCerebral InfarctionDementiaIron Deficiencies

Interventions

ferrous succinate

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesNeurocognitive DisordersMental DisordersAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBrain InfarctionBrain IschemiaStrokeInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Jia Qian, doctor

    Beijing Tiantan Hospital

    STUDY CHAIR

  • Zhang shuting, doctor

    West China Hospital

    STUDY DIRECTOR

Central Study Contacts

Jia Qian, doctor

CONTACT

15810048909jiaqian1616@163.com

Jia weili, doctor

CONTACT

1312020798713120207987@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Two nearly identical tablet forms of Ferrous iron (0.2g Ferrous iron and matching placebo) with almost the same size, color and smell will be used in this research.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
86(010)59978351

Study Record Dates

First Submitted

February 25, 2019

First Posted

March 27, 2019

Study Start

April 1, 2019

Primary Completion

October 31, 2021

Study Completion

December 31, 2021

Last Updated

July 13, 2020

Record last verified: 2020-07

Locations

CN(1)