Study on the relieving sensory discomfort in the extremities by anpleOne in patients with small vessel disease of the brain coexisting peripheral arterial stenosis

Seoul National University Hospital0 个研究点目标入组 40 人开始时间: 待定最近更新: 2020年2月24日

适应症

试验速览

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•(1) Adult men and women over 19 years old
•(2) At least 5 years of brain imaging on Brain MRI, SVD findings or similar (* for patients with headache: added at the bottom)
•(3) have been diagnosed with PAD
•One or more of the following conditions are satisfied.
•1) ABI less than 0.9
•2) Stenosis rate> 50% (Duplex ultrasound result PSV ratio> 2)
•Or patients with pain in the lower extremities (or limbs) during activity or rest
•(4) Patients who have not recently taken blood circulation improvers (ie, patients who have taken more than 4 weeks)
•(5) Those who have not had vascular related procedures for limb arteriovenous veins
•(6) Those who have not taken drugs that may affect the nerve sensation within the last 4 weeks
•(I.e. who takes more than 4 weeks)
•(7) Those who can read and answer the questionnaire
•(8) Who has given agreement to the written consent
•* Standard for headache patients
•-Selecting (ICHD 3 beta) migraine with / without aura according to International Headache Standard among primary headaches,
•The frequency of headaches during the first month prior to starting sarpogrelate (compared to monthly headache frequency after 3 months).
•Other criteria follow the general guidelines for studying headache patients. In particular, it is recommended to include more than 3 months old, headache frequency is more than 4 times / month, chronic migraine if more than 15 times / month depending on the energy.

•(1) patients with progressive neurological disease
•(2) Those who are already receiving the medication
•(3) Those who have clinically significant liver or kidney disease:
•ALT and / or AST and / or bilirubin is at least three times the upper limit of normal;
•Creatinine> 2.0mg / Dl (176.7µmol / L) or kidney dialysis
•(Inspection within the last three months)
•(4) A person who has undergone surgery or the like that cannot interfere with the absorption of drugs
•(5) those with other psychiatric disorders
•(6) Patients who took drugs within 4 weeks that could affect blood flow improvers, pain (including headaches), sensory measurements, etc.
•(7) alcohol or drug addicts
•(8) have a drug allergy or hypersensitivity
•(9) Those who are receiving other test drugs
•(10) Pregnant or lactating women and women of childbearing potential who do not have adequate contraception
•(11) Unreliable or incomplete patients as judged by
•(12) Patients with bleeding (if hemophilia, capillary placebo disease, gastrointestinal ulcers, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage, etc.)

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