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

• ClinicalTrials.gov Identifier: NCT00944333
• Recruitment Status: Terminated
• First Posted: July 23, 2009
• Last Update Posted: August 5, 2014
• Sponsor: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
• Information provided by (Responsible Party): Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

Tracking Information

• First Submitted Date: July 22, 2009
• First Posted Date: July 23, 2009
• Last Update Posted Date: August 5, 2014
• Study Start Date: July 2009
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 22, 2009): Definite and/or probable stent thrombosis occurring between 6 and 24 months [ Time Frame: 24 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Angina Pectoris
• Silent Ischemia

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: August 4, 2014): 1378
• Original Estimated Enrollment (submitted: July 22, 2009): 4000
• Actual Study Completion Date: July 2014
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT00944333
• Other Study ID Numbers: Security
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
• Study Sponsor: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
• Verification Date: August 2014