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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00944333
• Date of registration: 22/07/2009
• Primary sponsor: Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus
• Public title: Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy
• Scientific title: Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy
• Date of first enrolment: July 2009
• Target sample size: 4000
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00944333
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Italy

Contacts

• Name: Antonio Colombo, Dr.

• Name: Monica Repetto, Dr.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Angina Pectoris

Silent Ischemia

Intervention(s)

Drug: Clopidogrel

Primary Outcome(s)

Definite and/or probable stent thrombosis occurring between 6 and 24 months [Time Frame: 24 months]

Secondary Outcome(s)

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) [Time Frame: 24 months]

Secondary ID(s)

Security

Source(s) of Monetary Support

Please refer to primary and secondary sponsors