E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cardiovascular disease - subjects either with established disease or at high risk |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007648 |
E.1.2 | Term | Cardiovascular disease, unspecified |
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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 |
The primary aim of the trial is to assess whether a treatment strategy based on a cardiovascular 'polypill' (a multi-drug pill containing a fixed dose combination of 4 cardiovascular medications) compared to usual cardiovascular medications (similar medications but taken as single tablets) will improve adherence to prescribed medications (i.e. the patient is taking the medications they have been prescribed correctly). Difference in blood pressure and cholesterol between the beginning and end of the trial will serve as indicators of adherence to medication. |
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E.2.2 | Secondary objectives of the trial |
Secondary aims include assessing barriers to adherence (reviewing if the patient is taking the medications they have been prescribed, and if not, the reasons for stopping), quality of life (by using a health questionnaire), safety (reporting of serious adverse events), and to assess whether results are similar in the Netherlands, Ireland and India. A further aim is assess the impact of this polypill strategy on cardiovascular outcomes ( deaths and heart attacks and strokes) by combining data with these from other similar trials that will run in Australia, New Zealand, South Africa and China.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Individuals are eligible for inclusion if all of the following criteria are satisfied: •Adults (≥ 18 years) •The participant is able to give informed consent. •Established atherothrombotic cardiovascular disease (CVD) or high cardiovascular risk, defined as; History of coronary heart disease (myocardial infarction, stable or unstable angina pectoris, or coronary revascularisation procedure), or History of ischaemic cerebrovascular disease (ischaemic stroke or transient ischaemic attack), or History of peripheral vascular disease (peripheral revascularisation procedure or amputation due to vascular disease) OR For individuals without established cardiovascular disease, a calculated 5 year CVD risk of 15% or greater (calculated using the 1991 Anderson Framingham risk equation with adjustments as defined by the New Zealand Guidelines Group recommendations) •The trial Investigator considers that each of the polypill components are indicated •The trial Investigator is unsure as to whether a polypill-based strategy or usual care is better.
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E.4 | Principal exclusion criteria |
Individuals will NOT be eligible if one or more of the following criteria are satisfied: •Contraindication to any of the components of the polypill (e.g. known intolerance to aspirin, statins, or ACE inhibitors, pregnancy or likely to become pregnant during the treatment period). Such contraindications are fully listed in the Investigator Brochures. •The treating doctor considers that changing a participant’s cardiovascular medications would put the participant at risk (e.g. symptomatic heart failure, high dose β-blocker required to manage angina or for rate control in atrial fibrillation, accelerated hypertension, severe renal insufficiency, a history of severe resistant hypertension). Other potential reasons for exclusion include: •Known situation where medication regimen might be altered for a significant length of time, e.g. current acute cardiovascular event, planned coronary bypass graft operation. •Unlikely to complete the trial (e.g. life-threatening condition other than cardiovascular disease) or adhere to the trial procedures or attend study visits (e.g. major psychiatric condition, dementia).
Women of child bearing potential should be on a medically accepted form of contraception (oral or implanted contraception, IUD or tubal sterilisation). Final decisions about eligibility will be made at the discretion of the trial Investigator and potential trial participant, in light of any additional requirements or guidance from local ethics committees and other regulatory bodies.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcomes measures for the study are; •Adherence to medication; self-reported current use of antiplatelet, statin and combination (≥ 2) blood pressure lowering therapy at the end of trial follow-up. •Change in blood pressure from baseline to end of trial follow-up. •Change in LDL-cholesterol from baseline to end of trial follow-up.
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | 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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
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) | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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The end of the trial will be 12 months after the last participant randomised into the trial has had 12 months follow-up. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |