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Activity of Platelets After Inhibition and Cardiovascular Events Optical Coherence Tomography Study (APICE-OCT)

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ClinicalTrials.gov Identifier: NCT01239654
Recruitment Status : Completed
First Posted : November 11, 2010
Last Update Posted : May 23, 2012
Sponsor:
Collaborators:
Mediolanum Cardio Research
Cardiovascular Research Foundation, New York
Information provided by (Responsible Party):
Antonio Colombo, IRCCS San Raffaele

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

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Device: stent implantation Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Activity of Platelets After Inhibition and Cardiovascular Events: Drug Eluting Stent Implantation in Patients With Acute Coronary Syndrome: Optical Coherence Tomography Study
Study Start Date : September 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: everolimus
everolimus-eluting stent
Device: stent implantation
implantation of everolimus-eluting stent vs zotarolimus-eluting stent
Active Comparator: zotarolimus
zotarolimus-eluting stent
Device: stent implantation
implantation of everolimus-eluting stent vs zotarolimus-eluting stent



Primary Outcome Measures :
  1. Evaluate the completeness of neointimal coverage following stent implantation (everolimus vs. zotarolimus-eluting stent) in patients with ACS. [ Time Frame: 6 month ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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:

    1. History of drug allergy to thienopyridine derivatives or ASA;
    2. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239654


Locations
Italy
Università della Magna Grecia
Catanzaro, Italy, 88100
Careggi Hospital
Florence, Italy, 50134
San Raffaele Hospital
Milan, Italy, 20132
Ospedale Civile di Mirano
Mirano, Italy, 30035
Sponsors and Collaborators
IRCCS San Raffaele
Mediolanum Cardio Research
Cardiovascular Research Foundation, New York
Investigators
Principal Investigator: Antonio Colombo, MD IRCCS San Raffaele

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Antonio Colombo, Director of Invasive Cardiology, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT01239654     History of Changes
Other Study ID Numbers: APICE OCT Study (Project 4)
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: May 23, 2012
Last Verified: May 2012

Keywords provided by Antonio Colombo, IRCCS San Raffaele:
acute
coronary
syndrome
everolimus
zotarolimus
optical
coherence
tomography

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents