E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000891 |
E.1.2 | Term | Acute myocardial infarction |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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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 evaluate the efficacy of CSL112 in reducing the risk of MACE [Major adverse cardiovascular event(s)][ (CV (cardiovascular)death, MI (Myocardial Infarction), or stroke)] in subjects with ACS (Acute Coronary Syndrome),[diagnosed with STEMI (ST-segment elevation myocardial infarction) or NSTEMI(Non-ST-segment elevation myocardial infarction)].
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E.2.2 | Secondary objectives of the trial |
1. To evaluate the efficacy of CSL112 on reducing the total number of hospitalizations for coronary, cerebral, or peripheral ischemia.
2. To evaluate the efficacy of CSL112 on reducing the risk of MACE (CV death, MI, or stroke) in ACS (diagnosed with STEMI or NSTEMI) through 180 and 365 days
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female least 18 years of age
2. Evidence of myocardial necrosis, consistent with type (spontaneous) MI
3. No suspicion of acute kidney injury
4. Evidence of multivessel coronary artery disease and at least 1 of the following established risk factors:age ≥ 65 years, prior history of MI, diabetes mellitus, or peripheral artery disease
5. Presence of established cardiovascular risk factor(s):
a. Diabetes mellitus on pharmacotherapy OR
b. 2 or more of the following: age ≥ 65 years, prior history of MI, peripheral arterial disease
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E.4 | Principal exclusion criteria |
1. Ongoing hemodynamic instability
2. Evidence of hepatobiliary disease
3. Evidence of severe chronic kidney disease
4. Plan to undergo scheduled coronary artery bypass graft surgery as treatment for the index MI
5. Known history of allergies, hypersensitivity, or deficiencies to soy bean, peanut or albumin |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to first occurrence of any component of composite MACE (CV death, MI, or stroke ) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1) Total number of hospitalizations for coronary, cerebral, or peripheral ischemia
2) and 3) Time to first occurrence of CV death, MI, or stroke
4) Time to occurrence of CV death
5) Time to first occurrence of MI
6) Time to first occurrence of stroke
7) Time to first occurrence of CV death, type 1 MI, or stroke
8) Time to occurrence of all-cause death
9) Number and percent of subjects with adverse events
10) Number and percent of subjects with treatment-related adverse events
11) Number and percent of subjects with serious adverse events
12) Number and percent of subjects with a shift in clinical laboratory assessments from baseline to worst post-treatment |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1), 4), 5), 6), 9): Through 90 days
2): Through 180 days
3), 8), 10), 11): Through 365 days
7): Through 90, 180, and 365 days
12): Baseline and 29 days |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 370 |
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 | No |
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 |
Argentina |
Australia |
Brazil |
Canada |
Chile |
Colombia |
Hong Kong |
Israel |
Japan |
Korea, Republic of |
Malaysia |
Mexico |
New Zealand |
Peru |
Singapore |
South Africa |
Taiwan |
Thailand |
United States |
European Union |
Switzerland |
Georgia |
Russian Federation |
Turkey |
Ukraine |
Serbia |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 50 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 50 |