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
- Conditions
- 1. New onset angina 2. Acute coronary syndromes (ACS) to include ST elevation ACS and None ST elevation ACSTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2015-000273-13-GB
- Lead Sponsor
- niversity Hospitals of North Midlands NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
•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;
Clinical
•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
Follow up
•Inability to attend follow up appointments
Other
•Current or planned participation in another drug trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method