E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Types 1 and 2 diabetes mellitus. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012601 |
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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 |
To assess the effects of low dose aspirin on the incidence of major vascular events, in a wide range of people with type 1 or type 2 diabetes with no clinical evidence of vascular disease and receiving statins treatment. |
|
E.2.2 | Secondary objectives of the trial |
Total and cause specific mortality, venous thromboembolic episodes, major hemorrhagic episodes, and total number of hospitalizations for cardiovascular causes (myocardial infarction, stroke, acute coronary syndrome, not planned revascularization procedures, heart failure, transient ischemic attack, peripheral vascular disease, lower limb revascularization procedures). |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Written informed consent to participate in this study; Clinical diagnosis of type 1 or type 2 diabetes, irrespective of diabetes treatment; Need for statin treatment: - patients already receiving statin therapy irrespective of their actual LDL cholesterol and total cholesterol levels or - patients not currently on statin treatment with LDL-cholesterol levels >=110 mg/dL persisting after three months of dietary advise; Ability and willingness to comply with all study requirements. |
|
E.4 | Principal exclusion criteria |
Previous major vascular events (non-fatal myocardial infarction, non-fatal stroke, angina, transient ischemic attack, revascularization procedures, peripheral vascular disease); Unstable metabolic control (HbA1c >14.0%); Any condition requiring elective treatment with aspirin; Contraindications to aspirin; Contraindications to simvastatin; Chronic therapy with non steroidal antiinflammatory drugs; Presence of any life-threatening condition; Child-bearing potential (pre-menopausal women not using reliable contraception); History of active substance or alcohol abuse within the last year. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To assess the effects of low dose aspirin on the incidence of major vascular events (defined as a combined end-point of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or inpatient or outpatient hospital admission for cardiovascular causes, including acute coronary syndrome, not planned revascularization procedures, peripheral vascular disease), in a wide range of people with type 1 or type 2 diabetes with no clinical evidence of vascular disease and receiving statins treatment. |
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | 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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 6 |