E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I,II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia
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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 | HLT |
E.1.2 | Classification code | 10011085 |
E.1.2 | Term | Ischaemic coronary artery 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 |
The primary objective of this study is to test the non-inferiority of 6- versus 12- month dual antiplatelet therapy in patients with lesions treated with at least one second generation DES |
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E.2.2 | Secondary objectives of the trial |
Composite of major adverse cardiac events (MACE) defined as the occurrence at 24 months of cardiac death, or myocardial infarction, or urgent target vessel revascularization (cardiac bypass surgery, or repeat PTCA) Cardiac death at 30 days, 6, 12 and 24 months Myocardial infarction at 30 days, 6, 12 and 24 months Urgent target vessel revascularization at 30 days, 6, 12 and 24 months Possible stent thrombosis rate between 6 and 24 months Economic evaluation and comparison between the two arms at 24 months Bleeding events (major and minor) Any cause mortality at 12 and 24 months |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I,II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia, all treated with a second generation drug eluting stent 2. Presence of one or more de novo stenosis equal or greater than 70% in a native coronary artery, treated with a second generation drug eluting stent 3. Patient is > 18 years of age (or minimum age as required by local regulations). 4. The patient has consented to participate by signing the Patient Informed Consent Form. 5. The patient is willing and able to cooperate with study procedures and required follow up visits. 6. Any type of lesion or number of lesion can be included in this trial unless specifically detailed in the exclusion criteria. 7. At least one second generation DES implanted in the target lesion in the last 24 hours. 8. No other DES implanted before the target procedure 9. No BMS implanted in the 12 months before the target procedure |
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E.4 | Principal exclusion criteria |
1. Patients treated for lesions in venous or arterial grafts. 2. Patients treated for in-stent restenosis. 3. Patients treated for Unprotected Left Main lesions. 4. ST elevation myocardial infarction in the 48 hours prior to the procedure. 5. Non ST elevation myocardial infarction. 6. Patients with LVEF≤30%. 7. Women with known pregnancy or who are lactating. 8. Patients with hypersensitivity or allergies to heparin,, drugs such as ABT-578, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media. 9. Patients with chronic renal insufficiency (creatinine >2mg or mg or 180 mol/l) 10. Contraindication to the use of clopidogrel and/or ASA: a. History of drug allergy to thienopyridine derivatives or ASA; b. History of clinically significant or persistent thrombocytopenia or neutropenia 11. Active bleeding or significant risk of bleeding, such as elderly patients receining fibrinolytic therapy and other potent antithrombotic agents, severe hepatic insufficiency, current peptic ulceration., proliferative diabetic retinopathy. 12. Uncontrolled hypertension.. 13. Current medical condition with a life expectancy of less than 24 months. 14. The subject is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this trial. 15. Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Definite and/or probable stent thrombosis occurring between 6 and 24 months |
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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 | 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) | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
stesso farmaco, diverso regime |
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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 | 60 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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 | 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 | 4 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |