Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS; Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus
• Treatments: Clopidogrel; Ticlopidine

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