E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary and secondary prevention of hyperlideamia. |
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E.1.1.1 | Medical condition in easily understood language |
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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 |
To measure for each participant, what proportion of the side-effects they experience whilst taking statins is directly due to the drug itself. |
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E.2.2 | Secondary objectives of the trial |
This research study will lead to the future availability of an open-source application for any clinician or health care organisation to establish whether side-effects experienced are truly caused by the drug.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Previously taken one or more statins, • Withdrawn from statins because of perceived side effects • Developed side effects within 2 weeks of initiation • Primary or secondary prevention of cardiovascular disease or dyslipidaemia is the clinical indication for statins
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E.4 | Principal exclusion criteria |
• History of neuropathy • Regularly taking prescribed analgesia • History of a chronic pain condition • History of severe mental illness (as their experience of symptoms may already be altered) • Current use of fibrates (because of the risk of interaction with statins but will not exclude participants taking ezetimibe). • Severe previous reaction or reaction considered immunological, such as anaphylaxis, facial swelling, severe rash, muscle ache with rise in serum creatine kinase, inflammatory myopathy, rhabdomyolysis or liver function abnormalities (AST or ALT greater than 3 times upper limit or normal). • Side-effects taking longer than 2 weeks to develop (because in such participants much longer blocks of treatment would be required, if the present study is positive such studies will be planned for the future)*. • History of statin intolerance with drug interaction to antiretroviral drugs. • History of statin intolerance to any other drug. • Pregnant or breast feeding. • Side effects taking longer than 2 weeks to present. • In clinical judgement of study doctor, participant should not participate.
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E.5 End points |
E.5.1 | Primary end point(s) |
Symptom scoring Symptoms will be measured daily, on a 0-100 scale, with the daily scores aggregated into a monthly score. This is preferable over scoring only once a month, because patients may struggle to remember and aggregate their symptom burden especially if it varies between days.
EQ-5D-3L & TSQM Each month participants will fill out two validated questionnaires on the impact of their side-effects on quality of life. These are EQ-5D-3L, a well-validated measure of health related quality of life, and the TSQM questionnaire, a treatment satisfaction questionnaire. EQ-5D-3L assesses five domains of health and overall self-rated health using a visual analogue scale. EQ-5D-3L is conventional for assessing efficacy of medication on quality of life but may not be sufficient for assessing side effects, therefore the TSQM questionnaire will also be used. Use of both a health related quality of life questionnaire and treatment satisfaction questionnaire will allow assessment of participants’ multiple health states, overall self-rated health status and treatment satisfaction, and provide a test of both convergent validity and measurement invariance for our monthly aggregate symptom burden score.
Confounding life events We will also ask patients to fill in a short form detailing any potentially confounding life events over the previous month e.g. change of daily routine, holidays, bereavement, etc.
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E.5.1.1 | 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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Psychology of statin side effects |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
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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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End of trial is last visit of last subject. This last visit of last subject will take place six months after the last subject has completed the 12 months of the trial intervention (treatment, placebo, or no treatment) |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 1 |