Mobilisation of endothelial progenitor cells by statin therapy in patients with coronary disease: a proof of concept pilot study. - Mobilisation of endothelial progenitor cells and statin therapy PILOT

niversity Hospitals of North Midlands NHS Trust0 个研究点目标入组 20 人开始时间: 2015年3月10日最近更新: 2019年6月30日

试验速览

暂无简介。

•Participants aged between 18 and 75 years with new onset angina or
•Participants aged between 18 and 75 years with Acute Coronary Syndrome (ACS) diagnosed by a positive blood test called troponin that suggests a cardiac event
•Participants with new onset angina may be statin naïve
•Participants with ACS can either be stating naïve or reloaded with atorvastatin 80 mg
•All participants must have the ability to give informed consent
•All patients able to attend follow up visits
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•The exclusion criteria can be sub-divided into 5 categories;
•Unstable Angina as per clinical assessment / judgement
•Diabetes mellitus type I or II
•Stable angina group should be statin naive
•All participants must have no other significant comorbidity for example malignancy on or off therapy, chronic obstructive pulmonary disease on home oxygen or nebuliser therapy, inflammatory bowel disease, on going steroid therapy, autoimmune disease, therapy with disease modifying medications for rheumatic or autoimmune disease.
•Women who are pregnant or breastfeeding
•Allergies to excipients of IMP
•Women of child bearing potential unless they are using a recognised effective form of contraception or are not sexually active, and have no intention of becoming sexually active during the course of the trial.
•Previous adverse reaction or contra-indications
•Any contraindication(s) to statin therapy
•Any prior adverse reaction(s) to any statin therapy
•Biochemical
•Total cholesterol greater than 7.5 mmol/L
•Liver function tests deranged from normal range
•eGFR less than 90 ml/min/1.73m2
•Haematological
•Concurrent haematological conditions requiring active drug or chemotherapy
•Inability to attend follow up appointments
•Current or planned participation in another drug trial.

发起方

niversity Hospitals of North Midlands NHS Trust