E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients at moderate risk of CHD events (10-20% 10-year CHD risk; approximately 30% 10-year risk of CVD events based on the underlying
assumption at study start). |
|
E.1.1.1 | Medical condition in easily understood language |
Patients at moderate risk of Coronary Heart Disease events. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10072760 |
E.1.2 | Term | Transient ischemic attack |
E.1.2 | System Organ Class | 100000004852 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042244 |
E.1.2 | Term | Stroke |
E.1.2 | System Organ Class | 100000004852 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046251 |
E.1.2 | Term | Unstable angina |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028596 |
E.1.2 | Term | Myocardial infarction |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10049993 |
E.1.2 | Term | Cardiac death |
E.1.2 | System Organ Class | 10018065 - General disorders and administration site conditions |
|
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 evaluate the clinical effect of 100 mg enteric coated aspirin in the reduction of CVD events in patients at moderate risk of CHD events of approximately 10-20% 10-year risk). This corresponds to a
patient population mean 10-year CVD risk of approx 30% based on the underlying assumption at study start. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of the IMP in the same population. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- age
- elevated total cholesterol
- low HDL cholesterol
- elevated blood pressure
- family history of early CHD
- smoking
- on antihypertensive therapie
|
|
E.4 | Principal exclusion criteria |
- type I and type II diabetes
- prior history of a CVD events (clinical or diagnostic)
- standard exclusion criterias for ASA (see protocol)
- any condition likely to cause death within 5 years
- chronic, frequent use of NSAID´s or COX-2 inhibitors |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint will be a composite outcome consisting of a first occurence of confirmed MI, stroke, cardiovascular death, UA, or
TIA. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The composite primary endpoint will be evaluated at end of study. In addition, the study will be monitored by an independent Data Safety Monitoring Board (DSMB) at regular intervals during the course of the study. The DSMB will review all data to ensure the safety of patients, which they will do by analyzing adverse events and by performing interim analyses of the clinical outcome data. |
|
E.5.2 | Secondary end point(s) |
In addition, the following parameters will be used to assess the efficacy of the study drug:
• A composite outcome of the time to the first occurrence of
cardiovascular death, MI, or stroke (ischemic, hemorrhagic, or unknown)
• Time to the first non-fatal MI
• Time to the first MI (fatal or non-fatal)
• Time to first occurrence of a non-fatal stroke
• Time to first occurrence of fatal or non-fatal stroke
Analyses will also be presented for ischemic and hemorrhagic stroke separately, if appropriate.
• Time to cardiovascular death
• Time to the first occurrence of UA
• Time to the first occurrence of TIA
• Time to / incidence of all-cause mortality
• Time to first occurrence of / incidence of all cancers excluding
nonmelanoma skin cancer
• Time to first occurrence of / incidence of colon cancer
• Incidence of confirmed MI, stroke, cardiovascular death, UA, and TIA separately |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
The secondary endpoints will be evaluated at end of study.
In addition, the study will be monitored by an independent Data Safety Monitoring Board (DSMB) at regular intervals during the course of the study. The DSMB will review all data to ensure the safety of patients,
which they will do by analyzing adverse events and by performing
interim analyses of the clinical outcome data. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
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 | 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 | 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 | 100 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 400 |
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 |
|
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
|
The planned treatment duration is approx 72 months, which is
expected to result in a total exposure time of 60,000 patient-years.
LVLS expected approx im May 2016. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 8 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 8 |
E.8.9.2 | In all countries concerned by the trial months | 10 |