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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous succinate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | All-cause death | 1 year after randomization |
| Stroke recurrence (including hemorrhagic and ischemic stroke) | Stroke recurrence including hemorrhagic and ischemic stroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Qian, doctor | Contact | 15810048909 | jiaqian1616@163.com | |
| Jia weili, doctor | Contact | 13120207987 | 13120207987@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jia Qian, doctor | Beijing Tiantan Hospital | Study Chair |
| Zhang shuting, doctor | West China Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing tiantan hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38789134 | Derived | 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. |
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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.
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|
| 1 year after randomization |
| Poor functional outcome | The modified Rankin Scale (mRS range 0-6)= 2-6 | 1 year after randomization |
| Value of Hemoglobin/serum ferritin/serum Tau/serum Aß | Value of Hemoglobin/serum ferritin/serum Tau/serum Aß | 3 months and 1 year after randomization |
| ID | Term |
|---|---|
| D015140 | Dementia, Vascular |
| D018798 | Anemia, Iron-Deficiency |
| D002544 | Cerebral Infarction |
| D003704 | Dementia |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D020521 | Stroke |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| C022943 | ferrous succinate |
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