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Acute Coronary SyndromePhase 3APICE-OCTNCT01239654

Activity of Platelets After Inhibition and Cardiovascular Events Optical Coherence Tomography Study

A Phase 3 study testing stent implantation in people with Acute Coronary Syndrome, run by IRCCS San Raffaele at 4 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It is an exploratory study evaluating a biological effect (stent strut coverage) using a novel technology such as OCT without any clinical implication. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
stent implantation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
4 sitesItaly
Study dates
Sep 2010to Aug 2011
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 ACS and clinical indication to PCI
  • Presence of 1 or more de novo stenosis equal or greater than 70% in native coronary arteries.
  • 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 can be included in this trial unless specifically detailed in the exclusion criteria.
  • No other stent implanted before in the target lesion

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.
  • Patients with left ventricular ejection fraction (LVEF) ≤30%.
  • Patients with chronic kidney disease (creatinine ≥1.5 mg/dL) .
  • Women with known pregnancy or who are lactating.
Show all 14Show fewer
  • Patients with hypersensitivity or allergies to heparin, drugs such as ABT-578 and everolimus, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
  • 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 bleedings, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy.
  • 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

4 sites in 1 country.

Italy4 sites

  • Università della Magna Grecia

    Catanzaro, 88100

  • Careggi Hospital

    Florence, 50134

  • San Raffaele Hospital

    Milan, 20132

  • Ospedale Civile di Mirano

    Mirano, 30035

Other trials in Italy

About this study

Official title: Activity of Platelets After Inhibition and Cardiovascular Events: Drug Eluting Stent Implantation in Patients With Acute Coronary Syndrome: Optical Coherence Tomography Study

It is an exploratory study evaluating a biological effect (stent strut coverage) using a novel technology such as OCT without any clinical implication.

Read the detailed description

The question of whether DES are safe, has become an area of considerable interest and controversy with the publication of a relatively small randomized trial (BASKET-LATE), an observational study and a meta-analysis reporting increased rates of ST, MI, and death with DES compared to BMS. The motivating factor was the presentation of a meta-analysis at the European Society of Cardiology meeting in Barcelona in September 2006, which suggested an increase in the risk of death and MI following implantation of sirolimus-eluting stents.

The major issue in these meta-analyses is that they were limited either by small sample sizes, duration of follow-ups, lack of access to source data, or by using landmark analyses that excluded events in first 6 months.

Moreover, the largest meta-analysis of DES vs. BMS and SES vs. PES published recently in The Lancet by Settler et al performed a network analyses with a mixed-treatment comparison of 38 randomized trials (18023 patients) with a follow-up of up to 4 years. This analysis again confirmed that DES and BMS were associated with similar rates of overall and cardiac mortality Regarding "real world" population, two observational registries recently published, i.e. the Western Denmark Heart Registry and the SCAAR (Swedish Coronary Angiography and Angioplasty Registry) confirmed no difference in the hard endpoints between DES and BMS. However, it must be remembered that these studies are observational and at best are hypothesis-generating.

Some autoptic studies have observed an incomplete healing following first generation DES implantation as compared to BMS; in these series late ST was associated with more delayed healing compared with patent DES. Among all the unsettled or not fully tested indications for usage of DES, ACS is most probably the one where implantation of BMS remains the most used approach because of the uncertainty regarding the thrombotic risk of DES in a thrombus rich milieu and the low risk for restenosis following BMS implantation in patients with acute MI. Despite encouraging results from currently published data with DES, well designed and appropriately powered clinical trials are warranted in order to establish long term safety and efficacy (incremental advantage over BMS) of DES in this setting. Moreover, recently it was reported that exposed struts were more frequent with first generation DES, and percent neointimal hyperplasia(NIH) area was smaller in ACS lesions than in non-ACS lesions.

For this specific purpose, we will evaluate, using OCT, complete neointimal coverage of Everolimus- vs. Zotarolimus Eluting Stent implanted in the novo lesions on native coronary arteries in patients with ACS. Rates of exposed and/or malaposed stent struts will be analysed and neointimal hyperplasia (NIH) area will be calculated.

Being tested
stent implantation
Keywords
acute, coronary, syndrome, everolimus, zotarolimus, optical, coherence, tomography
Medical subject headings
Acute Coronary Syndrome, Syndrome

What participants receive

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

  • stent implantationDevice

    implantation of everolimus-eluting stent vs zotarolimus-eluting stent

Study groups in NCT01239654
Study groupRoleWhat they receive
everolimusActive comparatoreverolimus-eluting stent
Receives: Device: stent implantation
zotarolimusActive comparatorzotarolimus-eluting stent
Receives: Device: stent implantation

What is being measured

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

  1. Evaluate the completeness of neointimal coverage following stent implantation (everolimus vs. zotarolimus-eluting stent) in patients with ACS.

    Evaluate the completeness of neointimal coverage following stent implantation (everolimus vs. zotarolimus-eluting stent) in patients with ACS. The degree of neointimal coverage will be assessed using optical coherence tomography (OCT) calculating the rate of exposed stent struts in the study stents.

    Measured: 6 month

Timeline

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

  1. First posted11 Nov 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionAug 2011
  4. Study completionAug 2011

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01239654
Sponsor's protocol ID
APICE OCT Study (Project 4)
Acronym
APICE-OCT
Status last verified
May 2012
First submitted
10 Nov 2010
Last updated
23 May 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Barlis P, Regar E, Serruys PW, Dimopoulos K, van der Giessen WJ, van Geuns RJ, Ferrante G, Wandel S, Windecker S, van Es GA, Eerdmans P, Juni P, di Mario C. An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: a LEADERS trial sub-study. Eur Heart J. 2010 Jan;31(2):165-76. doi: 10.1093/eurheartj/ehp480. Epub 2009 Nov 4.

    PubMed 19889649

  • Xie Y, Takano M, Murakami D, Yamamoto M, Okamatsu K, Inami S, Seimiya K, Ohba T, Seino Y, Mizuno K. Comparison of neointimal coverage by optical coherence tomography of a sirolimus-eluting stent versus a bare-metal stent three months after implantation. Am J Cardiol. 2008 Jul 1;102(1):27-31. doi: 10.1016/j.amjcard.2008.02.091. Epub 2008 Apr 25.

    PubMed 18572031

  • Matsumoto D, Shite J, Shinke T, Otake H, Tanino Y, Ogasawara D, Sawada T, Paredes OL, Hirata K, Yokoyama M. Neointimal coverage of sirolimus-eluting stents at 6-month follow-up: evaluated by optical coherence tomography. Eur Heart J. 2007 Apr;28(8):961-7. doi: 10.1093/eurheartj/ehl413. Epub 2006 Nov 29.

    PubMed 17135281

  • Tahara S, Bezerra HG, Sirbu V, Kyono H, Musumeci G, Rosenthal N, Guagliumi G, Costa MA. Angiographic, IVUS and OCT evaluation of the long-term impact of coronary disease severity at the site of overlapping drug-eluting and bare metal stents: a substudy of the ODESSA trial. Heart. 2010 Oct;96(19):1574-8. doi: 10.1136/hrt.2009.188037. Epub 2010 Aug 23.

    PubMed 20736206

  • Guagliumi G, Sirbu V, Bezerra H, Biondi-Zoccai G, Fiocca L, Musumeci G, Matiashvili A, Lortkipanidze N, Tahara S, Valsecchi O, Costa M. Strut coverage and vessel wall response to zotarolimus-eluting and bare-metal stents implanted in patients with ST-segment elevation myocardial infarction: the OCTAMI (Optical Coherence Tomography in Acute Myocardial Infarction) Study. JACC Cardiovasc Interv. 2010 Jun;3(6):680-7. doi: 10.1016/j.jcin.2010.04.005.

    PubMed 20630463

  • Chieffo A, Buchanan GL, Parodi G, Versaci F, Bianchi RM, Valenti R, Sacca S, Mongiardo A, Span S, Migliorini A, Spaccarotella C, Reimers B, Antoniucci D, Indolfi C, Ferrari A, Maehara A, Mintz GS, Colombo A. Drug-eluting stent implantation in patients with acute coronary syndrome - the Activity of Platelets after Inhibition and Cardiovascular Events: Optical Coherence Tomography (APICE OCT) study. EuroIntervention. 2014 Dec;10(8):916-23. doi: 10.4244/EIJY14M06_10.

    PubMed 24974806

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing stent implantation in people with Acute Coronary Syndrome, run by IRCCS San Raffaele at 4 sites 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 7 inclusion and 14 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: finished, as of the sponsor's last update on 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Evaluate the completeness of neointimal coverage following stent implantation (everolimus vs. zotarolimus-eluting stent) in patients with ACS. (time frame: 6 month). 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 NCT01239654, which also lists 6 linked publications.

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 23 May 2012.

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