Vascular Cognitive ImpairmentPhase 2FAVORITENCT03891277
Efficacy and Safety of Ferrous Iron on the Prevention of Vascular Cognitive Impairment Among Patients With Cerebral Infarction/TIA (FAVORITE)
A Phase 2 study testing Ferrous succinate in people with Vascular Cognitive Impairment and Dementia, Vascular, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vascular Cognitive Impairment, Dementia, Vascular, Iron-deficiency
- What is being tested?
- Ferrous succinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,006 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing tiantan hospital
Beijing, Beijing Municipality, 100000
Jia Qian, doctor, 15810048909, jiaqian1616@163.com
Jia Weili, master, 13120207987, 13120207987@163.com
About this study
Official title: Efficacy and Safety of Ferrous Iron on the Prevention of Vascular Cognitive Impairment Among Patients With Cerebral Infarction/TIA,FAVORITE
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.
Read the 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.
- Conditions
- Vascular Cognitive Impairment, Dementia, Vascular, Iron-deficiency, Cerebral Infarction, TIA
- Being tested
- Ferrous succinate
- Keywords
- Vascular Cognitive Impairment, dementia, iron deficiency, cerebral infarction, TIA, biological markers, Clinical Trial
- Medical subject headings
- Dementia, Vascular, Anemia, Iron-Deficiency, Cerebral Infarction, Dementia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous succinateDrug
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ferrous succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year after randomization
Secondary outcomes (4)
All-cause death
All-cause death
Measured: 1 year after randomization
Stroke recurrence (including hemorrhagic and ischemic stroke)
Stroke recurrence including hemorrhagic and ischemic stroke
Measured: 1 year after randomization
Poor functional outcome
The modified Rankin Scale (mRS range 0-6)= 2-6
Measured: 1 year after randomization
Value of Hemoglobin/serum ferritin/serum Tau/serum Aß
Value of Hemoglobin/serum ferritin/serum Tau/serum Aß
Measured: 3 months and 1 year after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Apr 2019
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,006 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
- Investigators
- Jia Qian, doctor, Study chair, Beijing Tiantan HospitalZhang shuting, doctor, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891277
- Sponsor's protocol ID
- 2018YFC1312303
- Acronym
- FAVORITE
- Status last verified
- Jul 2020
- First submitted
- 25 Feb 2019
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38789134
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ferrous Iron on the Prevention of Vascular Cognitive Impairment Among Patients With Cerebral Infarction/TIA,FAVORITE
- ClinicalTrials.gov ID
- NCT03891277
- Acronym / sponsor ID
- FAVORITE / 2018YFC1312303
- Conditions
- Vascular Cognitive Impairment, Dementia, Vascular, Iron-deficiency, Cerebral Infarction, TIA
- Keywords
- Vascular Cognitive Impairment, dementia, iron deficiency, cerebral infarction, TIA, biological markers, Clinical Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,006 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferrous succinate | Active comparator | Drug: Ferrous succinateFerrous succinate sustained-release tablets（Ferrous succinate 0.2g）1 tablet, Qd, po during or after breakfast, Lasting for 12 weeks. |
| placebo | Placebo comparator | Drug: Ferrous succinateplacebo 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous succinateAlso: PlaceboFerrous 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. | Drug | Ferrous succinate, placebo |
Primary outcome
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
4 secondary outcomes
All-cause death
Time frame: 1 year after randomization
Stroke recurrence (including hemorrhagic and ischemic stroke)
Time frame: 1 year after randomization
Poor functional outcome
Time frame: 1 year after randomization
Value of Hemoglobin/serum ferritin/serum Tau/serum Aß
Time frame: 3 months and 1 year after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Derived from this study: PubMed 38789134Jia 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.
Related trials for Vascular Cognitive Impairment
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Not yet recruitingObservational study
Chinese University-Alzheimer's Disease With Vascular and Other Co-pathology: Towards Actionable Neuro-Cognitive-Omic Evaluations (CU-ADVANCE)
Alzheimer s Disease, Mild Cognitive Impairment (MCI)
Not yet recruiting
COG+OT Telerehabilitation for Adults With Subjective Cognitive Complaints
Subjective Cognitive Complaints, Ehlers-Danlos Syndrome
RecruitingObservational study
China HEalthy Aging and Dementia Study (HEAD)
Alzheimer Disease (AD), Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Qian, doctor study chair
Beijing Tiantan Hospital
Zhang shuting, doctor study director
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ferrous succinate in people with Vascular Cognitive Impairment and Dementia, Vascular, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Qian, doctor (15810048909, jiaqian1616@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of vascular cognitive impairment in patients given Ferrous succinate versus placebo (time frame: 1 year after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03891277, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020.