Overview

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