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

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ClinicalTrials.gov Identifier: NCT03891277
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
Yongjun Wang, Beijing Tiantan Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Vascular Cognitive Impairment Dementia, Vascular Iron-deficiency Cerebral Infarction TIA Drug: Ferrous succinate Phase 2

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1006 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ferrous Iron on the Prevention of Vascular Cognitive Impairment Among Patients With Cerebral Infarction/TIA,FAVORITE
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ferrous succinate
Ferrous succinate sustained-release tablets（Ferrous succinate 0.2g）1 tablet, Qd, po during or after breakfast, Lasting for 12 weeks.
 Drug: Ferrous succinate

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.

Other Name: Placebo
Placebo Comparator: placebo
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

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.

Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. prevalence of vascular cognitive impairment in patients given Ferrous succinate versus placebo [ Time Frame: 1 year after randomization ]
    Vascular cognitive impairment will be diagnosed with Montreal Cognitive Assessment(MoCA, range 0-30 scores) <26 scores


Secondary Outcome Measures :
  1. All-cause death [ Time Frame: 1 year after randomization ]
    All-cause death

  2. Stroke recurrence (including hemorrhagic and ischemic stroke) [ Time Frame: 1 year after randomization ]
    Stroke recurrence including hemorrhagic and ischemic stroke

  3. Poor functional outcome [ Time Frame: 1 year after randomization ]
    The modified Rankin Scale (mRS range 0-6)= 2-6

  4. Value of Hemoglobin/serum ferritin/serum Tau/serum Aß [ Time Frame: 3 months and 1 year after randomization ]
    Value of Hemoglobin/serum ferritin/serum Tau/serum Aß


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891277


Contacts
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Contact: Jia Qian, doctor 15810048909 jiaqian1616@163.com
Contact: Jia weili, doctor 13120207987 13120207987@163.com

Locations
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China, Beijing
Beijing tiantan hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Jia Qian, doctor    15810048909    jiaqian1616@163.com   
Contact: Jia Weili, master    13120207987    13120207987@163.com   
Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
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Study Chair: Jia Qian, doctor Beijing Tiantan Hospital
Study Director: Zhang shuting, doctor West China Hospital
More Information
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Responsible Party: Yongjun Wang, 86(010)59978351, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT03891277    
Other Study ID Numbers: 2018YFC1312303
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: July 13, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yongjun Wang, Beijing Tiantan Hospital:
Vascular Cognitive Impairment
dementia
iron deficiency
cerebral infarction
 TIA
biological markers
Clinical Trial
Additional relevant MeSH terms:
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Dementia
Cerebral Infarction
Dementia, Vascular
Anemia, Iron-Deficiency
Infarction
Cognitive Dysfunction
Ischemia
Pathologic Processes
Necrosis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
 Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Stroke
Vascular Diseases
Cardiovascular Diseases
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis