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TerminatedNCT00944333Updated Aug 5, 2014

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

A Phase 3 interventional study of Clopidogrel and Clopidogrel in Angina Pectoris and Silent Ischemia, sponsored by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS. Terminated at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-05.

Sponsored by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS · Phase 3, Interventional, and Treatment

Why this study was 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.
Phase
Phase 3
Study type
Interventional
Enrollment
1,378
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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)
03

In context

Angina Pectoris

528 studies on the registry are indexed under Angina Pectoris; 80 are open to participants now.

This study's enrollment of 1,378 is above the median of 122 across 343 interventional studies indexed under Angina Pectoris.

Browse Angina Pectoris studies →

Lead sponsor

Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,378 participants (actual)

Study arms

  • Experimental
    Clopidogrel 6

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

    Drug: Clopidogrel

  • Experimental
    Clopidogrel 12

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

    Drug: Clopidogrel

Interventions

  • DrugClopidogrel

    300-600 loading dose 75 mg/die for 6 months

  • DrugClopidogrel

    300-600 loading dose 75 mg/die for 12 months

06

What researchers measure

Primary outcomes

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

    Time frame: 24 months

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Irccs Fondazione Centro S. Raffaele Del Monte Tabor -
    Milano (mi), 20132, Italy
08

References and documents

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. PubMed 25236346 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2009, a primary completion of Jun 2014 and a completion of Jul 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2009
First posted
Jul 23, 2009
Start
Jul 2009
Primary completionActual
Jun 2014
CompletionActual
Jul 2014
Last update
Aug 5, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00944333
Lead sponsor
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Responsible party
Sponsor
First posted
Jul 23, 2009
Start date
Jul 2009
Primary completion
Jun 2014
Completion
Jul 2014
Last update
Aug 5, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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