E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The medical condioton to be investigated is recurrent cardiovascular disease |
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E.1.1.1 | Medical condition in easily understood language |
recurrent cardiovascular disease |
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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 |
The aim of this comparative effectiveness research is to determine the effect of intake of aspirin before bedtime in comparison with aspirin on awakening in patients already using aspirin for secondary prevention of CVD. Our primary objective will be to assess the major adverse cardiovascular events. |
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E.2.2 | Secondary objectives of the trial |
Our secondary objectives are: • Time of the day of primary outcome: it is expected that bedtime aspirin reduces the primary outcome more during morning hours (6-12h) compared with the rest of the day. • Safety: severe or moderate bleeding events according to established definitions. • Side-effects. • Cost-effectiveness: patients’ quality of life (EQ-5D-5L) will be registered at randomization and after that with a frequency of twice per year during follow-up to calculate QALYs. Health care utilization data are extracted from electronic patient records and data from the primary care. Health care use will be translated into cost using Dutch reference prices. • Subgroup analyses will be performed for gender and age.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
patients who already use low-dose aspirin for secondary prevention of cardiovascular events and use a multidose drug dispensing |
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E.4 | Principal exclusion criteria |
Insufficient knowledge of the Dutch language Patients currently participating in another (clinical) trial or study |
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E.5 End points |
E.5.1 | Primary end point(s) |
Effect of aspirin intake at bedtime compared with intake at morning on cardiovascular disease |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of the study period of max. 4 years. |
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E.5.2 | Secondary end point(s) |
• Time of the day of primary outcome: it is expected that bedtime aspirin reduces the primary outcome more during morning hours (6-12h) compared with the rest of the day. • Safety: severe or moderate bleeding events according to established definitions. • Side-effects • Cost-effectiveness: patients’ quality of life (EQ-5D-5L) will be registered at randomization and after that with a frequency of twice per year during follow-up to calculate QALYs. Health care utilization data are extracted from electronic patient records and data from the primary care. Health care use will be translated into cost using Dutch reference prices. • Subgroup analyses will be performed for gender and age (18-50, 50-65, 65-85 and 85+). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the end of the study period of max. 4 years.
An interim analysis will be performed when 50% of the target number of subjects has been included, and again when 75% has been included. The incidence of side effects in the two groups (evening users/ intervention group versus morning users/ control group) will be compared, with special attention to major bleeding in the intervention group. |
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | Yes |
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 | 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 | 2 |
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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The end of the study is defined as the last patient’s last visit. |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |