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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital; Yongjun Wang, MD
• Treatments: Ferrous succinate; Iron

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.