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Angina PectorisPhase 3NCT00944333

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

A Phase 3 study testing Clopidogrel in people with Angina Pectoris and Silent Ischemia, run by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Angina Pectoris, Silent Ischemia
What is being tested?
Clopidogrel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,378 participants
Where
1 siteItaly
Study dates
Jul 2009to Jul 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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

Who cannot join

  • 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%
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Irccs Fondazione Centro S. Raffaele Del Monte Tabor -

    Milano (mi), 20132

Other trials in Italy

About this study

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).

Read more

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.

Being tested
Clopidogrel
Keywords
second generation DES, clopidogrel, dual platelet therapy, patients with documented silent ischemia, unstable angina pectoris (Braunwald Classification), Diagnosis of angina pectoris (CCS)
Medical subject headings
Angina Pectoris, Angina, Unstable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClopidogrelDrug

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

  • ClopidogrelDrug

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

Study groups in NCT00944333
Study groupRoleWhat they receive
Clopidogrel 6Experimental6 month dual antiplatelet therapies in patients after second generation DES implantation
Receives: Drug: Clopidogrel
Clopidogrel 12Experimental12 month dual antiplatelet therapies in patients after second generation DES implantation
Receives: Drug: Clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 24 months

Secondary outcomes (1)

  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)

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJun 2014
  4. Study completionJul 2014

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,378 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00944333
Sponsor's protocol ID
Security
Status last verified
Aug 2014
First submitted
22 Jul 2009
Last updated
5 Aug 2014
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Clopidogrel in people with Angina Pectoris and Silent Ischemia, run by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Definite and/or probable stent thrombosis occurring between 6 and 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00944333, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2014.

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