Efficacy and Safety of Ferrous Iron on the Prevention of Vascular Cognitive Impairment Among Patients With Cerebral Infarction/TIA (FAVORITE)

Last updated: July 10, 2020
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Dementia

Stroke

Vascular Dementia

Treatment

N/A

Clinical Study ID

NCT03891277
2018YFC1312303
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, ordyslipidemia, with multiply lacunar infarctions(≥2) or extensive white matterlesions（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 forfemale,or ≥60 g/L and <130g/L for male)

  4. Signed informed consent.

Exclusion

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 evaluationfor 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、NMDAantagonists、5-hydroxytryptophan receptor antagonists、pyrrolidone and other definitedrugs for improving cognition(e.g. donepezil、Galanthamine、Memantine、huperzineA、oxiracetam、aniracetam、piracetam、butyphthalide) within 3 months before randomization；

  8. Patients with severe liver or kidney insufficiency(ALT>twofold upper normal limit orAspartate Aminotransferase>twofold upper normal limit; Cr>1.5 times upper normal limitor 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 geographicalfactor or other reasons;

  15. Patients or legal representatives refuse to participate.

Study Design

Total Participants: 1006
Study Start date:
April 01, 2019
Estimated Completion Date:
December 31, 2021

Study Description

The prevalence of Vascular Cognitive Impairment(VCI) remains 21%~70% among patients after ischemic stroke or TIA. Effective therapy for the prevention of VCI remains limited. Abnormal iron distribution and Systemic iron deficiency may contribute partly to the occurrence of VCI.The primary purpose of this study is to evaluate the efficacy and safety of Ferrous iron versus placebo in reducing the risk of VCI at 1 year in patients with cerebral Infarction/TIA complicated with Hemoglobin deficiency. The secondary purpose is to evaluate the effect of Ferrous iron on the Biological markers of VCI; to evaluate the effect of iron supplement on the outcome(death,stroke recurrence, dependency) of patients with ischemic stroke or TIA complicated with Hemoglobin deficiency at 3 months/1 year after treatment.

This trial is a randomized, double-blind, placebo-controlled, multicenter clinical trial. 1006 patients in 20 centers in China will be enrolled with one of the following situations 1.recent ischemic stroke or TIA (within 3 months) with Fe deficiency （serum ferritin<20µg/L）or Hemoglobin deficiency(<120g/L for female and <130g/L for male).2. Vascular risk factors(hypertension, diabetes mellitus, or dyslipidemia), with multiply lacunar infarctions(≥2) or extensive white matter lesions（Fazekas ≥2） or multiply microhaemorrhage(≥2) showed on CT/Magnetic Resonance(MR) with Fe deficiency （serum ferritin<20µg/L）or Hemoglobin deficiency(<120g/L for female and <130g/L for male).. Patients will be randomly assigned into 2 groups according to the ratio of 1:1:

Ferrous iron therapy (0.2 per day) Placebo Face to face interviews will be made at baseline, 14 (or hospital discharge), 3th month± 7 days and 12th month ± 14 days after randomization.

Primary outcome is defined as prevalence of Vascular Cognition Impairment at 1 year after treatment. Secondary outcomes include all-cause death; ischemic stroke; transient ischemic attack; poor functional outcome (mRS 2-6). Safety outcomes, relating to adverse gastrointestinal reactions and iron overload.

Connect with a study center

  • Beijing tiantan hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

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