E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Percutaneous coronary intervention (PCI) due to an acute ischemic event |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066642 |
E.1.2 | Term | Acute myocardial ischemia |
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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 safety of administration of Ilomedin® for 24 hours after PCI in addition to standard treatment with regard to development of bleeding and/or hypotension |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effect of Ilomedin® administration on endothelial activation/necrosis and platelet activation and aggregation after PCI
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1)Age > 18 years 2)Undergoing primary PCI due to STEMI (TIMI flow 0-III before PCI and symptom duration < 12 hours) 3)Eligible for receiving platelet GPIIb/IIIa inhibitor (Integrillin®) therapy during and after PCI procedure as based on investigator judgement 4)Post-PCI treatment with Clopidogrel and ASA 5)No sign of significant or increased bleeding risk up to 18 hours following the PCI as evaluated by the treating physician 6)Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study data is used
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E.4 | Principal exclusion criteria |
1)Known HIV positive 2)Not able to give informed consent 3)Women with childbearing potential 4)Concomitant treatment with K-vitamin antagonists (one bolus dose pre-PCI allowed) 5)Known congenital or acquired coagulopathy and/or thrombocytopathy 6)Heparin treatment except for dose given pre-PCI treatment 7)Received within 30 days prior to Day 1 prostacyclin or GPIIIB/IIA inhibitors 8)Participation in a clinical study and/or another investigational device within the past four weeks prior to Day 1 9)Major surgery or trauma within the past 6 weeks prior to Day 1 10)A blood coagulation disorder (i.e. international normalized ratio [INR] > 2.0, platelet count < 100,000/mm3, or hematocrit < 30%) 11)Renal insuffience (creatinine > 140 mmol/l) 12)Major procedure related bleeding (TIMI major criteria); GI or urinary tract bleeding prior to inclusion in the trial 13)Known active hepatitis B and/or hepatitis C or HIV 14)Known or suspected hypersensitivity to components of the investigational medicinal product
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E.5 End points |
E.5.1 | Primary end point(s) |
•Bleeding complications as evaluated by TIMI and GUSTO criteria during the 24 hour Ilomedin® infusion. •Adverse events(death, stent thrombosis, need for urgent revascularization)
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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 | Yes |
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) | 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 | 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
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The end of the study is defined as database lock, as this is the of clinical data collection. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
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 |