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

This study is currently recruiting participants.
Verified August 2013 by Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus
Sponsor:
Information provided by (Responsible Party):
Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus
ClinicalTrials.gov Identifier:
NCT00944333
First received: July 22, 2009
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Angina Pectoris
Silent Ischemia
Drug: Clopidogrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy

Resource links provided by NLM:


Further study details as provided by Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus:

Primary Outcome Measures:
  • Definite and/or probable stent thrombosis occurring between 6 and 24 months [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 4000
Study Start Date: July 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clopidogrel 6
6 month dual antiplatelet therapies in patients after second generation DES implantation
Drug: Clopidogrel
300-600 loading dose 75 mg/die for 6 months
Experimental: Clopidogrel 12
12 month dual antiplatelet therapies in patients after second generation DES implantation
Drug: Clopidogrel
300-600 loading dose 75 mg/die for 12 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944333

Contacts
Contact: Monica Repetto, Dr. 02.34535088 ext 29 repetto@mcr-med.com

Locations
Italy
Irccs Fondazione Centro S. Raffaele Del Monte Tabor - Recruiting
Milano (mi), Italy, 20132
Contact: Antonio Colombo, Dr.    02.26437331    colombo@emocolumbus.it   
Contact: Alaide Chieffo, Dr.    02.26437331    chieffo.alaide@hsr.it   
Principal Investigator: Maurizio Tespili, Dr.         
Principal Investigator: Gennaro Sardella, Prof.         
Principal Investigator: Patrizia Presbitero         
Principal Investigator: Giorgio Binetti, Dr.         
Principal Investigator: Cataldo Palmieri, Dr.         
Principal Investigator: Corrado Tamburino, Dr.         
Principal Investigator: Amerigo Stabile, Dr.         
Principal Investigator: Giuseppe Carosio, Prof.         
Sponsors and Collaborators
Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus
  More Information

No publications provided

Responsible Party: Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus
ClinicalTrials.gov Identifier: NCT00944333     History of Changes
Other Study ID Numbers: Security
Study First Received: July 22, 2009
Last Updated: August 13, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus:
second generation DES
clopidogrel
dual platelet therapy
patients with documented silent ischemia
unstable angina pectoris (Braunwald Classification)
Diagnosis of angina pectoris (CCS)

Additional relevant MeSH terms:
Angina Pectoris
Ischemia
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Pathologic Processes
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 16, 2014