A randomized, double-blind, double placebo, parallel group, phase 4 clinical trial to compare the incidence of headache according to dosing regimen of Adinox® capsules in patients with transient ischemic attacks or ischemic stroke

Chodang Pharm0 个研究点目标入组 192 人开始时间: 待定最近更新: 2020年11月3日

适应症

试验速览

暂无简介。

•1) Age of 19 years or older
•2) Patients who have transient ischemic attacks or non-cardioembolic ischemic stroke confirmed by MRI within 3 weeks of screeining
•3) A patient who has adequate bone marrow, liver and kidney function and meets the following criteria as a result of the laboratory test confirmed at the time of screening
•?Platelet count = 100×103/µL
•?Hemoglobin = 8 g/dl
•?ALT (alanine aminotransferase) and AST (aspartate aminotransferase) = 100 IU/L
•?ALP (alkaline phosphatase) = 2.5 times the normal upper limit
•?Serum Total bilirubin = 1.25 times the normal upper limit
•?Serum albumin = 2.5 g/dl
•?Creatinine clearance,CCr = 30 mL/min
•4) Prior to registration of the clinical trial, patient who signed the written informed consent by hand

•1) History of non-traumatic intracranial bleeding within 6 months prior to screening
•2) Planned angiography and vascular intervention or surgical procedure/operation before the end of study
•3) Patient with the following medical history or diseases
•? History of hypersensitivity to dipyridamole and aspirin
•? Brain tumor
•? Bleeding diathesis or coagulopathy
•? Severe coronary artery disease (unstable angina, acute myocardial infarction)
•? Aortic stenosis
•? History of allergy to nonsteroidal anti-inflammatory drugs
•? Heart failure [NYHA (New York Heart Association) Class ?/?]
•4) Patients with migraine history within 1 month of screening
•5) Patients who need anticoagulant treatment or have restrictions on antiplatelet treatment
•6) Pregnant and nursing mothers, patients planning to become pregnant, or patients who disagree with medically acceptable birth control
•7) Patients who participated in another clinical trial within 2 months of screening or are currently participating
•8) Patients who are judged to be unsuitable for participation in the study because they cannot follow the clinical trial and follow-up procedures in the judgment of the investigator.

发起方

Chodang Pharm