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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00944333
Recruitment Status : Terminated (STOP due to recent data in literature questioning the need to continue DAP beyond six months in patients with stable coronary artery stenting with DES.)
First Posted : July 23, 2009
Last Update Posted : August 5, 2014
Sponsor:
Information provided by (Responsible Party):
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

Tracking Information
First Submitted Date  ICMJE July 22, 2009
First Posted Date  ICMJE July 23, 2009
Last Update Posted Date August 5, 2014
Study Start Date  ICMJE July 2009
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2009)
Definite and/or probable stent thrombosis occurring between 6 and 24 months [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy
Official Title  ICMJE Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy
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 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Angina Pectoris
  • Silent Ischemia
Intervention  ICMJE
  • Drug: Clopidogrel
    300-600 loading dose 75 mg/die for 6 months
  • Drug: Clopidogrel
    300-600 loading dose 75 mg/die for 12 months
Study Arms  ICMJE
  • Experimental: Clopidogrel 6
    6 month dual antiplatelet therapies in patients after second generation DES implantation
    Intervention: Drug: Clopidogrel
  • Experimental: Clopidogrel 12
    12 month dual antiplatelet therapies in patients after second generation DES implantation
    Intervention: Drug: Clopidogrel
Publications * Colombo A, Chieffo A, Frasheri A, Garbo R, Masotti-Centol M, Salvatella N, Oteo Dominguez JF, Steffanon L, Tarantini G, Presbitero P, Menozzi A, Pucci E, Mauri J, Cesana BM, Giustino G, Sardella G. Second-generation drug-eluting stent implantation followed by 6- versus 12-month dual antiplatelet therapy: the SECURITY randomized clinical trial. J Am Coll Cardiol. 2014 Nov 18-25;64(20):2086-97. doi: 10.1016/j.jacc.2014.09.008. Epub 2014 Sep 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 4, 2014)
1378
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2009)
4000
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00944333
Other Study ID Numbers  ICMJE Security
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Study Sponsor  ICMJE Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP