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 risk; approximate 20-30% 10-year risk of CVD). |
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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 | 10028596 |
E.1.2 | Term | Myocardial infarction |
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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 objective of this study is to evaluate the clinical effects of a 100 mg/day enteric-coated acetylsalicylic acid versus placebo in the reduction of CVD events in patients at moderate risk of major CHD events (10-20% 10-year risk; approximate 20-30% 10-year risk of CVD). |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate the safety and tolerability of the 100 mg/day enteric-coated acetylsalicylic acid versus placebo in the same patient population. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Males aged 50 years and above with 2 or 3 risk factors Male Risk Factors Males aged 60 and above Elevated cholesterol (Tchol>200 mg/dL or LDL>130 mg/dL; as measured at screening) irrespective of current treatment Current smoking*: defined as any cigarette smoking in the past 12 months (*smoking cannot be the sole risk factor for males aged 60 and above) Low HDL cholesterol (HDL<40 mg/dL; as measured at screening) Elevated blood pressure (SBP>140 mmHg; as measured at screening) Currently on any medication to treat high blood pressure Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years) 2. Females aged 60 and above with 3 or more risk factors Female Risk Factors Elevated cholesterol (Tchol>240 mg/dL or LDL>160 mg/dL; as measured at screening) Current smoking: defined as any cigarette smoking in the past 12 months Low HDL cholesterol (HDL<40 mg/dL; as measured at screening) Elevated blood pressure (SBP>140 mmHg; as measured at screening) Currently on any medication to treat high blood pressure Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years) 3. An understanding and willingness to comply with trial procedures and has given written informed consent to participate in the trial |
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E.4 | Principal exclusion criteria |
1. Clinical history of CVD, MI, stroke, coronary artery angioplasty or stenting,coronary artery bypass graft, relevant arrhythmias, or congestive heart failure 2. Patients who are at higher than moderate risk on the basis of: a) their diabetes status (i.e. those with Type I or Type II diabetes actively treated with drug therapy) b) other factors known to the investigator (e.g. a male patient over 60 years of age with 4 or more risk factors) c) the currently used national risk score 3. Any medical condition, or psychiatric or substance abuse disorder, that, in the opinion of the investigator, is likely to affect the patients ability to complete the study or precludes the patients participation in the study 4. Lactating women or women of childbearing potential 5. Known increased risk of bleeding, e.g., gastric or duodenal ulcer, genitourinary causes or other bleeding disorders. 6. Known/diagnosed reflux esophagitis. 7. Moderately impaired renal function based on the clinical judgment of the investigator. 8. Severe liver disease or damage based on the clinical judgment of the investigator. 9. A history of asthma induced by administration of salicylates or substances with a similar action, notably NSAIDs 10. History of hypersensitivity or drug allergy to acetylsalicylic acid 11. A definite indication for acetylsalicylic acid therapy, other anti-platelet drug, or anticoagulant in the opinion of the physician 12. Chronic, frequent (> 5 days/month) use of NSAIDs, COX-2 inhibitors or metamizole (acetaminophen/paracetamol and other non NSAID pain medications will be permitted) 13. Current participation in any other trials involving investigational products within 30 days prior to the Screening Visit. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint will be a composite outcome consisting of the first occurrence of cardiovascular death, MI, or stroke. |
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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 | 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 | 20 |
E.8.5 | The trial involves multiple Member States | Yes |
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 | 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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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 | 0 |
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 |