E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Coronary heart disease with stable angina or non-ST elevation myocardial infarction (NSTEMI) |
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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 | 10051592 |
E.1.2 | Term | Acute coronary syndrome |
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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 |
Aim of this study is to evaluate safety and efficacy of Iloprost in protecting coronary microcirculation during percutaneous angioplasty thanks to the action of Iloprost against vasoactive substances delivered during coronary dilatation. Iloprost efficacy will be detected by the capacity of the drug to reduce the incidence and severity of enzyme dismission after elective or urgent coronary angioplasty in patients without ST-elevation myocardial infarction (STEMI) |
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E.2.2 | Secondary objectives of the trial |
the incidence and severity of enzyme dismission after elective or urgent coronary angioplasty in patients without ST-elevation myocardial infarction (STEMI) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria 1. Age > 18 y 2. Stable angina or inducible ischemia 3. Acute myocardial infarction without ST elevation (NSTEMI) 4. Planned angioplasty on one, two or three coronary lesions 5. Informed Consent
Subgroup with coronary flow study Acute myocardial infarction without ST elevation (NSTEMI) Planned angioplasty on only one stenosis or on double lesion on single vessel |
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E.4 | Principal exclusion criteria |
Exclusion Criteria 1. Atrial fibrillation (cases with coronary flow study) 2. ST elevation acute myocardial infarction (STEMI) 3. Contraindications to anti-platelet therapy or IIb/IIIa inhibitors 4. Hypertension (> 180/100 mmHg) 5. Planned angioplasty on more than three coronary stenoses 6. Two or more of the following procedural characteristics: stenoses in coronary bifurcations, multiple stenoses, stenoses in saphenous aorto-coronary grafts 7. Pregnancy or fertile age
Subgroup with coronary flow study Atrial fibrillation Proximal tortuosity of the vessel |
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E.5 End points |
E.5.1 | Primary end point(s) |
Peri-procedural myocardial infarction detected by an increase of T-Troponin (T-Troponin > 0,1 ng/mL (> Three times the normal upper limit of 0,03 ng/mL in the Laboratory of Azienda Ospedaliera S.Orsola Malpighi) |
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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 | 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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 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
| |
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 | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |