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ALLiance for sEcondary PREvention After an Episode of Acute Coronary Syndrome (ALLEPRE) (ALLEPRE)

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ClinicalTrials.gov Identifier: NCT02522182
Recruitment Status : Recruiting
First Posted : August 13, 2015
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Diego Ardissino, Azienda Ospedaliero-Universitaria di Parma

Brief Summary:
The purpose of the ALLEPRE trial is to compare the benefit offered by a structured, intensive and fully nurse-led intensive secondary prevention intervention programme with that offered by standard of care in a high-risk population of patients admitted to hospital because of an ACS.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Behavioral: Nurse-led Intensive Secondary Prevention Programme Behavioral: Usual Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2060 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: ALLiance for sEcondary PREvention After an Episode of Acute Coronary Syndrome. The ALLEPRE Trial: a Fully Nurse-led Intensive Intervention Programme
Study Start Date : October 2012
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Intensive Secondary Prevention Programme
The Nurse-led Intensive Secondary Prevention Programme consists of programmed 9 sessions involving the trained nurses and the patients randomised to the experimental programme: before discharge, and one, three, six, 12, 18, 24, 36 and 48 months follow up. During the sessions the nurse will record the main clinical parameters (risk factors, lifestyle habits, adherence to therapy, psychological characteristics), any discrepancies between patient reports and the recommended goals and then activate the interventions in order to correct the discrepancies. The activation of the pre-established multidisciplinary network (anti-smoking, anti-diabetes and anti-hypertension centres, and psychological support) is completely under the nurses' control.
Behavioral: Nurse-led Intensive Secondary Prevention Programme
Information related to intervention description have been already included in arm/group description

Active Comparator: Usual Treatment
The patients randomised to the control group will follow the Usual Treatment for secondary prevention of the hospital to which they were admitted
Behavioral: Usual Treatment
Information related to intervention description have been already included in arm/group description




Primary Outcome Measures :
  1. The difference in the degree of adherence to the goals concerning risk factors, lifestyle modifications and pharmacological therapy. [ Time Frame: 24 months ]

    Adherence to the goals of classic cardiovascular risk factors:

    - number of patients (nop) with systolic blood pressure <140 mmHg, divided by total nop.


  2. The difference in the degree of adherence to the goals concerning risk factors, lifestyle modifications and pharmacological therapy. [ Time Frame: 24 months ]

    Adherence to the goals of classic cardiovascular risk factors:

    - nop with LDL cholesterol <70 mg/dL, divided by total nop.


  3. The difference in the degree of adherence to the goals concerning risk factors, lifestyle modifications and pharmacological therapy. [ Time Frame: 24 months ]

    Adherence to the goals of classic cardiovascular risk factors:

    - number of non-smokers, divided by the total nop.


  4. The difference in the degree of adherence to the goals concerning risk factors, lifestyle modifications and pharmacological therapy. [ Time Frame: 24 months ]

    Adherence to the goals of classic cardiovascular risk factors:

    - nop with HbAC1 <7%, divided by total nop.


  5. The difference in the degree of adherence to the goals concerning risk factors, lifestyle modifications and pharmacological therapy. [ Time Frame: 24 months ]
    The number of patients with the target body mass index (18-24.9) divided by the total nop.

  6. The difference in the degree of adherence to the goals concerning risk factors, lifestyle modifications and pharmacological therapy. [ Time Frame: 24 months ]

    Adherence to life style modifications:

    - Number of patients eating at least 5 servings friut/vegetable/day divided by total nop at month 24.


  7. The difference in the degree of adherence to the goals concerning risk factors, lifestyle modifications and pharmacological therapy. [ Time Frame: 24 months ]
    The number of patients eating at least 2 fish servings/wk divided by the total

  8. The difference in the degree of adherence to the goals concerning risk factors, lifestyle modifications and pharmacological therapy. [ Time Frame: 24 months ]

    Adherence to life style modifications:

    The number of patients spending at least 30 min/d, 5 times/wk on recreational exercise divided by the total number of patients.


  9. The difference in the degree of adherence to the goals concerning risk factors, lifestyle modifications and pharmacological therapy. [ Time Frame: 24 months ]

    Adherence to medications:

    The number of patients with a high degree of adherence to medications (Morisky Medication Adherence Scale score 3-4) divided by the total nop.


  10. Major adverse events [ Time Frame: 5 years ]
    Composite of cardiovascular mortality, non-fatal reinfarction, non-fatal stroke


Secondary Outcome Measures :
  1. Clinical endpoints [ Time Frame: 5 years ]
    a composite of cardiovascular mortality, nonfatal reinfarction, and nonfatal troke and myocardial ischemia-driven revascularization.

  2. Clinical endpoints [ Time Frame: 5 years ]
    non-fatal reinfarction

  3. Clinical endpoints [ Time Frame: 5 years ]
    non-fatal stroke

  4. Clinical endpoints [ Time Frame: 5 years ]
    cardiovascular mortality

  5. Clinical endpoints [ Time Frame: 5 years ]
    All-cause mortality



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

Inclusion Criteria:

Eligible patients aged >18 years with an ACS (unstable angina, non- ST-segment elevation myocardial infarction [MI], or ST-segment elevation MI [International Classification of Diseases, Ninth Revision, Clinical Modification codes 41071, 41001, 41011, 41021, 41031, 41041, 41051,41061, 41081, and 41091]) who are admitted to the Cardiological Divisions of the 6 participating centers in Emilia-Romagna (Italy) are considered for enrolment for up to 20 days after the index event and before being discharged.

Exclusion Criteria:

Once it has been verified that the patients are capable of participating in a prospective study, the only exclusion criterion is a life expectancy of b12 months because of a severe noncardiac disease


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): NCT02522182


Contacts
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Contact: Giorgia Paoli, MD 00393383334649 gpaoli@ao.pr.it
Contact: Maria Mattioli, MD 00393291534616 maria.mattioli@hotmail.it

Locations
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Italy
Ospedale di Baggiovara Recruiting
Baggiovara, Modena, Italy, 41126
Contact: Stefano Tondi, MD    00393355424598    stefano.tondi@fastwebnet.it   
Sub-Investigator: Luca Bertelli, MD         
Ospedale Ramazzini di Carpi Recruiting
Carpi, Modena, Italy, 41012
Contact: Giampiero Patrizi, MD    0039059659320    g.patrizi@ausl.mo.it   
Ospedale di Vaio Recruiting
Fidenza, Parma, Italy, 43036
Contact: Paolo Moruzzi, MD    00390524515831    pmoruzzi@ausl.pr.it   
Contact: Antonio Antonio, MD    00393388573666      
Sub-Investigator: Antonio Rizzo, MD         
Sub-Investigator: Gaia Trapolin, MD         
Ospedale Sant'Anna Recruiting
Castelnovo ne' Monti, Reggio Emilia, Italy
Contact: Antonio Manari, MD    00393471521003    Antonio.Manari@asmn.re.it   
Sub-Investigator: Gianni Zobbi, MD         
Ospedale Civile di Guastalla Recruiting
Guastalla, Reggio Emilia, Italy, 42020
Contact: Alessandro Navazio, MD    0030522837307    alessandro.navazio@ausl.re.it   
Azienda Ospedaliero-Universitaria di Parma Recruiting
Parma, Italy, 43126
Contact: Giorgia Paoli, MD    00393383334649    gpaoli@ao.pr.it   
Contact: Maria Mattioli, MD    00393291534616    maria.mattioli@hotmail.it   
Sub-Investigator: Giorgia Paoli, MD         
Sub-Investigator: Maria Mattioli, MD         
Sub-Investigator: Emilia Solinas, MD         
Sub-Investigator: Sara Fusco, MD         
Sub-Investigator: Christian Fava, MD         
Sub-Investigator: Francesca Preti, MD         
Sub-Investigator: Clelia Guerra, MD         
Sub-Investigator: Laura Dall'Oglio, MD         
Sub-Investigator: Sebastian Cinconze, MD         
Ospedale Guglielmo da Saliceto Recruiting
Piacenza, Italy, 29121
Contact: Massimo Piepoli, MD    00390523303217    m.piepoli@ausl.pc.it   
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Parma
Investigators
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Principal Investigator: Diego Ardissino, MD Azienda Ospedaliero-Universitaria di Parma
Publications of Results:
Perk J, De Backer G, Gohlke H, Graham I, Reiner Z, Verschuren M, Albus C, Benlian P, Boysen G, Cifkova R, Deaton C, Ebrahim S, Fisher M, Germano G, Hobbs R, Hoes A, Karadeniz S, Mezzani A, Prescott E, Ryden L, Scherer M, Syvänne M, Scholte op Reimer WJ, Vrints C, Wood D, Zamorano JL, Zannad F; European Association for Cardiovascular Prevention & Rehabilitation (EACPR); ESC Committee for Practice Guidelines (CPG). European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts). Eur Heart J. 2012 Jul;33(13):1635-701. doi: 10.1093/eurheartj/ehs092. Epub 2012 May 3. Erratum in: Eur Heart J. 2012 Sep;33(17):2126.

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Responsible Party: Diego Ardissino, MD, Azienda Ospedaliero-Universitaria di Parma
ClinicalTrials.gov Identifier: NCT02522182    
Other Study ID Numbers: E35E09000880002
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Keywords provided by Diego Ardissino, Azienda Ospedaliero-Universitaria di Parma:
Cardiovascular Secondary Prevention
Nurse's Role
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases