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

Primary Purpose

Angina Pectoris, Silent Ischemia

Status
Terminated
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Clopidogrel
Clopidogrel
Sponsored by
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina Pectoris focused on measuring second generation DES, clopidogrel, dual platelet therapy, patients with documented silent ischemia, unstable angina pectoris (Braunwald Classification), Diagnosis of angina pectoris (CCS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Irccs Fondazione Centro S. Raffaele Del Monte Tabor -

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Clopidogrel 6

Clopidogrel 12

Arm Description

6 month dual antiplatelet therapies in patients after second generation DES implantation

12 month dual antiplatelet therapies in patients after second generation DES implantation

Outcomes

Primary Outcome Measures

Definite and/or probable stent thrombosis occurring between 6 and 24 months

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)

Full Information

First Posted
July 22, 2009
Last Updated
August 4, 2014
Sponsor
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
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1. Study Identification

Unique Protocol Identification Number
NCT00944333
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
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.
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Silent Ischemia
Keywords
second generation DES, clopidogrel, dual platelet therapy, patients with documented silent ischemia, unstable angina pectoris (Braunwald Classification), Diagnosis of angina pectoris (CCS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1378 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clopidogrel 6
Arm Type
Experimental
Arm Description
6 month dual antiplatelet therapies in patients after second generation DES implantation
Arm Title
Clopidogrel 12
Arm Type
Experimental
Arm Description
12 month dual antiplatelet therapies in patients after second generation DES implantation
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
300-600 loading dose 75 mg/die for 6 months
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
300-600 loading dose 75 mg/die for 12 months
Primary Outcome Measure Information:
Title
Definite and/or probable stent thrombosis occurring between 6 and 24 months
Time Frame
24 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Irccs Fondazione Centro S. Raffaele Del Monte Tabor -
City
Milano (mi)
ZIP/Postal Code
20132
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25236346
Citation
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.
Results Reference
derived

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

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