Efficacy and Safety of Ferrous Iron on the Prevention of Vascular Cognitive Impairment Among Pati… (NCT03891277) | Clinical Trial Compass
UnknownPhase 2
Efficacy and Safety of Ferrous Iron on the Prevention of Vascular Cognitive Impairment Among Patients With Cerebral Infarction/TIA (FAVORITE)
China1,006 participantsStarted 2019-04-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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)
✕. 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；
What they're measuring
1
prevalence of vascular cognitive impairment in patients given Ferrous succinate versus placebo
✕. 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）;