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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064348 |
E.1.2 | Term | Non STEMI |
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 RO4905417 in reducing the procedural
damage during PCI |
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E.2.2 | Secondary objectives of the trial |
To evaluate the changes in other cardiac and renal biomarkers
To evaluate the safety of RO4905417 by monitoring of adverse
events and the incidence of MACEs at 30 and 120 days after PCI
after a single dose of study drug |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult patients, > 18 years old and < 85 years
Non ST-elevation myocardial infarction
Woman of childbearing potential will be allowed only if using two acceptable methods of contraception
Body mass index (BMI) </= 40 kg/m2
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E.4 | Principal exclusion criteria |
Acute ST-elevation myocardial infarction (STEMI)
Culprit coronary lesion with a total thrombotic occlusion or a lesion requiring the use of distal embolization protection or thrombectomy devices
Percutaneous coronary intervention (PCI) within the past 72 hours
Thrombolytic therapy within the past 7 days
Major surgery within the past 3 months
History of cerebral vascular disease or stroke in the past 3 months
Bleeding disorders
Inadequately controlled severe hypertension
Prior coronary artery bypass graft (CABG) surgery
Decompensated heart failure (oedema and/or rale)
Acute infection at screening or active chronic infection within 3 months prior to PCI
Patients known to be HIV positive, patients receiving antiretroviral drugs, or immuno-suppressed patients
Uncontrolled diabetes mellitus (HbA1C > 10%) at baseline
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduction of procedural damage during percutaneous coronary intervention (PCI): Change from baseline in troponin I levels early after PCI |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
from baseline to 24 hours post PCI |
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E.5.2 | Secondary end point(s) |
Change from baseline in troponin I at 8 hours post PCI Peak and AUC for troponin I
Change from baseline in Creatine Kinase-Myocardial Band (CK-MB) after PCI Change form baseline in Growth Differentiation Factor 15 (GDF-15) at 120 days post PCI
Change from baseline in cystatin C biomarker at 24 hours and 30 days post PCI
Safety: Incidence of adverse events and major adverse cardiovascular events (MACEs) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
from baseline to 120 days hours post PCI |
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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 | 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 | Yes |
E.6.11 | Pharmacogenomic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 3 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 23 |
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 |
Canada |
Poland |
United States |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |