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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)

Primary Purpose

Vascular Cognitive Impairment, Dementia, Vascular, Iron-deficiency

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Ferrous succinate

About this trial

This is an interventional treatment trial for Vascular Cognitive Impairment focused on measuring Vascular Cognitive Impairment, dementia, iron deficiency, cerebral infarction, TIA, biological markers, Clinical Trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Beijing tiantan hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ferrous succinate

placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

All-cause death

Stroke recurrence (including hemorrhagic and ischemic stroke)

Stroke recurrence including hemorrhagic and ischemic stroke

Poor functional outcome

The modified Rankin Scale (mRS range 0-6)= 2-6

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

Full Information

NCT ID

NCT03891277

First Posted

February 25, 2019

Last Updated

July 10, 2020

Sponsor

Beijing Tiantan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03891277

Brief Title

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

Acronym

FAVORITE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

October 31, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vascular Cognitive Impairment, Dementia, Vascular, Iron-deficiency, Cerebral Infarction, TIA

Keywords

Vascular Cognitive Impairment, dementia, iron deficiency, cerebral infarction, TIA, biological markers, Clinical Trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

1006 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ferrous succinate

Arm Type

Active Comparator

Arm Description

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

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Ferrous succinate

Other Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

1 year after randomization

Secondary Outcome Measure Information:

Title

All-cause death

Description

All-cause death

Time Frame

1 year after randomization

Title

Stroke recurrence (including hemorrhagic and ischemic stroke)

Description

Stroke recurrence including hemorrhagic and ischemic stroke

Time Frame

1 year after randomization

Title

Poor functional outcome

Description

The modified Rankin Scale (mRS range 0-6)= 2-6

Time Frame

1 year after randomization

Title

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

Description

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

Time Frame

3 months and 1 year after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jia Qian, doctor

Phone

15810048909

jiaqian1616@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jia weili, doctor

Phone

13120207987

13120207987@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jia Qian, doctor

Organizational Affiliation

Beijing Tiantan Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Zhang shuting, doctor

Organizational Affiliation

West China Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Beijing tiantan hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jia Qian, doctor

Phone

15810048909

jiaqian1616@163.com

First Name & Middle Initial & Last Name & Degree

Jia Weili, master

Phone

13120207987

13120207987@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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