E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with diffuse CAD undergoing percutaneous treatment on a native coronary vassel with planned implantation of 33 mm of DES with reference vessel diameter 2.25-4.0 mm. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011076 |
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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 |
compare the efficacy and, secondarily, the safety and effectiveness of pre-procedural use of the Gp IIb/IIIa inhibitor eptifibatide in comparison to placebo in patients with diffuse CAD undergoing multiple DES implantation. |
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E.2.2 | Secondary objectives of the trial |
to compare the safety and effectiveness of pre-procedural use of the Gp IIb/IIIa inhibitor eptifibatide in comparison to placebo in patients with diffuse CAD undergoing multiple DES implantation. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
male or female able to understand and sign a witnessed informed consent; age /equal 18 years; patients with stable or unstable anginapectoris or documented silent ischemia; stable hemodynamic conditions; no clinical ECG changes suggestive of ongoing acute or recent 48 hours myocardial infarction;angiographic inclusion criteria see the protocol |
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E.4 | Principal exclusion criteria |
Female sex with childbearing potential Age 18 years Ongoing or recent episode 48 hours of unstable coronary artery disease including both ST-elevation and non-ST-elevation acute coronary syndromes Administration of any GP IIb/IIIa inhibitors during the previous 2 weeks Serum creatinine 2.5 mg/dl or 350 micromols/l Ongoing serious bleeding or bleeding diathesis Previous stroke in the last 6 months Major surgery within the previous 6 weeks Platelet count 100,000 per mm3 Ejection Fraction below 30 The patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, rapamycin, or sensitivity to contrast which cannot be adequately pre-medicated. Hemodynamic instability systolic blood pressure 100 mm Hg; heart rate 40 bpm or 100 bpm; complex ventricular arrhythmias; AV block requiring balloon counterpulsation or inotropic support. The patient is simultaneously participating in another device or drug study. Patient must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this study. Positive clinical history for intracranial neoplasia, AV malformation, aneurysm. INR 8805; 2.0 or prothrombin time 1.2 times upper limit of normality Clinically manifested reduced liver function Programmed surgery within six months |
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E.5 End points |
E.5.1 | Primary end point(s) |
rate of post procedural peak CK-MB ratio values above the upper limit of normal. |
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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 | 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 | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | 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.8.5 | 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 | Information not present in EudraCT |
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 | 2 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |