Status:
TERMINATED
Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy
Lead Sponsor:
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Conditions:
Angina Pectoris
Silent Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 crite...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
1378 Patients enrolled
Trial Details
Trial ID
NCT00944333
Start Date
July 1 2009
End Date
July 1 2014
Last Update
August 5 2014
Active Locations (1)
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1
Irccs Fondazione Centro S. Raffaele Del Monte Tabor -
Milano (mi), Italy, 20132