second generation" drug-eluting stents implantation followed by six versus twelve-month - dual antiplatelet therapy

Conditions: Angina Pectoris; Silent Ischemia

Summary: prospective, randomized, non-inferiority, multicenter, international study.in total 4000 patients (70 centers in europe) with de novo lesions in native coronary arteries who meet the eligibility criteria randomized to 6 versus 12 month dual antiplatelet therapies following a second generation des implantation. assuming that the true proportion of thrombotic events is equal to 2.3% for both regimens (6-month and 12-month clopidogrel) 2000 patients for each treatment group are necessary to demonstrate a non-inferiority of the 6-months regimen if the proportion of thrombotic events will be no more than 3.5% with a power of 0.80 and a significance level of 0.05 (one-tail). if the non-inferiority hypothesis will be rejected, the superiority hypothesis (12-months regimen is superior to the 6-months-regimen) will be tested at a significance level of 0.05 (two-tails). the maximal not clinically relevant difference for the non-inferiority hypothesis of 1.2 % more thrombotic events has to be considered together with the lower expected number of bleeding events in the 6-months regimen. all the analysis will be done as "intention-to-treat" analysis.


Eligibility criteria:
inclusion criteria: * 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 * presence of one or more de novo stenosis equal or greater than 70% in a native coronary artery, treated with a resolute drug eluting stent * patient is \> 18 years of age (or minimum age as required by local regulations). * the patient has consented to participate by signing the "patient informed consent form"" * the patient is willing and able to cooperate with study procedures and required follow up visits * any type of lesion or number of lesion can be included in this trial unless specifically detailed in the exclusion criteria. * at least one second generation des implanted in the target lesion in the last 24 hours * no other des implanted before the target procedure * no bms implanted in the 12 months before the target procedure exclusion criteria: * patients treated for lesions in venous or arterial grafts * patients treated for in-stent restenosis * patients treated for unprotected left main lesions * st elevation myocardial infarction in the 48 hours prior to the procedure * non st elevation myocardial infarction * patients with lvef≤30% * women with known pregnancy or who are lactating * patients with hypersensitivity or allergies to hepari, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media. * patients with chronic renal insufficiency * contraindication to the use of clopidogrel and/or asa: * history of drug allergy to thienopyridine derivatives or asa * history of clinically significant or persistent thrombocytopenia or neutropenia * 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 * uncontrolled hypertension * current medical condition with a life expectancy of less than 24 months. * 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. * patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study

Keywords: second generation des clopidogrel dual platelet therapy patients with documented silent ischemia unstable angina pectoris (braunwald classification) diagnosis of angina pectoris (ccs)