E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
1. New onset angina 2. Acute coronary syndromes (ACS) to include ST elevation ACS and None ST elevation ACS |
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E.1.1.1 | Medical condition in easily understood language |
1. Newly diagnosed angina 2. Participants admitted with a heart attack |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
This initial proof of concept pilot study will firstly confirm that our current flow cytometric assays allow identification and quantification of endothelial progenitor cells (EPCs) in patients with cardiovascular disease on statin therapy. Secondly to assess time and temperature stability of our samples.
• Develop expertise with cardiology and haematology for whole blood flow cytometric assay for EPCs, in particular the stability of samples both at room temperature and 40 C • Sample Stability overtime • To Identify the time course of EPC mobilisation • Identify any obvious differences between acute coronary syndrome patients and stable ischaemic heart disease/new onset angina patients.
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E.2.2 | Secondary objectives of the trial |
• To establish whether a fully- powered controlled trial is feasible. • To establish the likely staffing resources and timetable needed for a fully-powered controlled trial.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• 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
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E.4 | Principal exclusion criteria |
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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary objective • Develop expertise with cardiology and haematology for whole blood flow cytometric assay for EPCs, in particular the stability of samples both at room temperature and 40 C • Sample Stability overtime • To Identify the time course of EPC mobilisation • Identify any obvious differences between acute coronary syndrome patients and stable ischaemic heart disease/new onset angina patients.
To summarise this pilot study will allow the following;
• Develop expertise with cardiology and haematology for whole blood flow cytometric assay for EPCs. • To identify the time course of EPC mobilisation. • Assess time and temperature stability of samples. • To identifying any obvious differences between acute coronary syndrome patients and stable angina patients. • The results of the pilot study will allow presentation of abstract(s) at both national and international meetings if accepted.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• To establish whether a fully- powered controlled trial is feasible. • To establish the likely staffing resources and timetable needed for a fully-powered controlled trial.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 1 |