ALLiance for sEcondary PREvention After an Episode of Acute Coronary Syndrome (ALLEPRE)
NCT ID: NCT02522182
Last Updated: 2025-03-26
Study Results
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Basic Information
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COMPLETED
NA
2060 participants
INTERVENTIONAL
2012-10-31
2025-01-31
Brief Summary
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Detailed Description
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All eligible patients are randomised 1:1 to the nurse-led intensive secondary prevention programme (ISPP: intervention/experimental arm) or usual treatment (UT: control arm).
Randomisation is centralised by means of IVRS under the responsibility of the Study Coordinator and the Principal Investigator at each hospital centre, and the patients are the allocated to groups by e-mail. Due to the nature of the study, neither participants nor research personnel can be blinded to the group assignments. The randomisation data are kept at the coordinating centre.
OPERATIVE PHASE After randomisation, all of the patients in both arms undergo a baseline examination and are required to return to their reference centre for follow-up visits after 12, 24 and 60 months for outcome assesment. Outcomes will also be recorded after 36 and 48 months on the basis of telephone enquiries.
ISPP: intervention arm. This consists of a series of programmed sessions involving the centrally trained nurses and the patients randomised to the ISPP. There will be a total of nine sessions: before discharge, and one, three, six, 12, 18, 24, 36 and 48 months after discharge. During the sessions, each of which will last for about one hour, the trained nurse will record the main clinical parameters (i.e. risk factors, lifestyle habits, adherence to therapy, and any discrepancies between patient reports and the recommended goals) using an ad hoc clinical file (SIM: scheda infermieristica multidimensionale or multidimensional nursing form), and then activate the interventions laid down by the pre-specified rules inside the SIM 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.
Caregivers are encouraged to support the patients in achieving behavioural changes over time.
Adherence to the proven secondary prevention treatments is monitored using the Morisky scale in order to ensure that each of the following classes of cardioprotective medications are prescribed according to the guidelines at the doses used in clinical trials: antiplatelet therapy, beta-blockers, angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, and statins. The reasons for non-adherence also investigated in order to ensure more targeted interventions. The risk factor and lifestyle behaviour goals are to stop smoking, eat a healthy Mediterranean diet, undertake physical activity for at least 30 minutes/day on five days/week, and maintain a body mass index (BMI) of \<25 kg/m2, systolic blood pressure of \<140, LDL cholesterol levels of \<70 mg/dL (1.81 mmol/L). A further goal for all diabetic subjects is good glycemic control.
The nurses also assess the subjects' psychological characteristics by means of a questionnaire that measures anxiety, depression, anger and hostility, type A and type D personality, perceived social support and perceived self-efficacy, and use an ad hoc questionnaire for referral to a psychologist if necessary.
To ensure the same nurse intervention in all partecipating centers the study started with a preliminary TRAINING PHASE involving professional nurses proposed by the participating centres (6-10 per centre, 50% from a hospital setting, 50% from a community setting). The training programme was coordinated by the Training and Continuous Education Centre of Parma University Hospital, and delivered by a multidisciplinary team of medical/nursing/psychological experts with the aid of ad hoc paper-based teaching materials. It consisted of three 8-hour sessions held on consecutive days during which the nurses were trained in secondary CVD prevention and how to take multi-dimensional and structured responsibility for ACS patients using appropriate communication strategies aimed at reducing risk factors, modifying lifestyles and improving adherence to prescribed pharmacological therapy. The programme was repeated four times in order to allow the creation of small groups (20 participants) and better interactions.
UT: control arm. The patients randomised to the control group will follow the standard for secondary prevention of the hospital to which they were admitted.
DATA MANAGEMENT All of the data are peripherally recorded in electronic case report forms and stored for further analysis. An external monitoring provides for all partecipating centrers the clinical data verification, the accuracy and the completeness of electronic case report forms.
Sample size and statistical aspects On the basis of the results of the GRACE UK-Belgian Study, it is conservatively expected that the cumulative rate of clinical endpoints in the standard care arm (cardiovascular mortality, non-fatal reinfarction, non-fatal stroke) during the five years' follow-up will be 28%. Using the formula of Lakatos and Lan (Statistics in Medicine, 1992), in order to detect a 25% risk reduction in the experimental group, with 90% power and a two-sided significance level of 0.25, at least 1030 patients are required in each group.
However, a two-year interim analysis of the major clinical endpoint will show the real divergence of the curves and provide further information for estimating the required duration of the study more precisely. The estimated sample size is also valid for the analysis of the first primary endpoint.
The plan of the primary and secondary analyses includes a Kaplan-Meier analysis of the time to an event, the HR, and log-rank comparisons based on the ITT and PP populations.
The baseline characteristics of the intervention and control group will be compared using the chi-squared test for categorical factors and Student's t test for independent samples for continuous factors. The data will be expressed as mean values ± standard deviations. All of the statistical analyses will be made using the SPSS programme.
A secondary heterogeneity analysis of the primary clinical outcomes will be made by stratifying the patients by age, sex, center, literacy level, diabetes, hypertension, smoking habits, family history, type of myocardial infarction (STEMI vs NSTEMI), and hospital characteristics. Analysis of repeated measures will be used to evaluate the changes in the primary surrogate end point over time.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Nurse-led Intensive Secondary Prevention Programme
Information related to intervention description have been already included in arm/group description
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
Usual Treatment
Information related to intervention description have been already included in arm/group description
Interventions
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Nurse-led Intensive Secondary Prevention Programme
Information related to intervention description have been already included in arm/group description
Usual Treatment
Information related to intervention description have been already included in arm/group description
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Azienda Ospedaliero-Universitaria di Parma
OTHER
Responsible Party
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Diego Ardissino
MD
Principal Investigators
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Diego Ardissino, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero-Universitaria di Parma
Locations
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Ospedale di Baggiovara
Baggiovara, Modena, Italy
Ospedale Ramazzini di Carpi
Carpi, Modena, Italy
Ospedale di Vaio
Fidenza, Parma, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, Parma, Italy
Ospedale Guglielmo da Saliceto
Piacenza, Piacenza, Italy
Ospedale Sant'Anna
Castelnovo ne' Monti, Reggio Emilia, Italy
Ospedale Civile di Guastalla
Guastalla, Reggio Emilia, Italy
Countries
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References
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Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.
Kotseva K, Wood D, De Backer G, De Bacquer D, Pyorala K, Keil U; EUROASPIRE Study Group. Cardiovascular prevention guidelines in daily practice: a comparison of EUROASPIRE I, II, and III surveys in eight European countries. Lancet. 2009 Mar 14;373(9667):929-40. doi: 10.1016/S0140-6736(09)60330-5.
Fox KA, Carruthers KF, Dunbar DR, Graham C, Manning JR, De Raedt H, Buysschaert I, Lambrechts D, Van de Werf F. Underestimated and under-recognized: the late consequences of acute coronary syndrome (GRACE UK-Belgian Study). Eur Heart J. 2010 Nov;31(22):2755-64. doi: 10.1093/eurheartj/ehq326. Epub 2010 Aug 30.
Clark AM, Hartling L, Vandermeer B, McAlister FA. Meta-analysis: secondary prevention programs for patients with coronary artery disease. Ann Intern Med. 2005 Nov 1;143(9):659-72. doi: 10.7326/0003-4819-143-9-200511010-00010.
Wood DA, Kotseva K, Connolly S, Jennings C, Mead A, Jones J, Holden A, De Bacquer D, Collier T, De Backer G, Faergeman O; EUROACTION Study Group. Nurse-coordinated multidisciplinary, family-based cardiovascular disease prevention programme (EUROACTION) for patients with coronary heart disease and asymptomatic individuals at high risk of cardiovascular disease: a paired, cluster-randomised controlled trial. Lancet. 2008 Jun 14;371(9629):1999-2012. doi: 10.1016/S0140-6736(08)60868-5.
Giannuzzi P, Temporelli PL, Marchioli R, Maggioni AP, Balestroni G, Ceci V, Chieffo C, Gattone M, Griffo R, Schweiger C, Tavazzi L, Urbinati S, Valagussa F, Vanuzzo D; GOSPEL Investigators. Global secondary prevention strategies to limit event recurrence after myocardial infarction: results of the GOSPEL study, a multicenter, randomized controlled trial from the Italian Cardiac Rehabilitation Network. Arch Intern Med. 2008 Nov 10;168(20):2194-204. doi: 10.1001/archinte.168.20.2194.
Jorstad HT, von Birgelen C, Alings AM, Liem A, van Dantzig JM, Jaarsma W, Lok DJ, Kragten HJ, de Vries K, de Milliano PA, Withagen AJ, Scholte Op Reimer WJ, Tijssen JG, Peters RJ. Effect of a nurse-coordinated prevention programme on cardiovascular risk after an acute coronary syndrome: main results of the RESPONSE randomised trial. Heart. 2013 Oct;99(19):1421-30. doi: 10.1136/heartjnl-2013-303989. Epub 2013 Jun 28.
de Lorgeril M, Salen P, Martin JL, Monjaud I, Delaye J, Mamelle N. Mediterranean diet, traditional risk factors, and the rate of cardiovascular complications after myocardial infarction: final report of the Lyon Diet Heart Study. Circulation. 1999 Feb 16;99(6):779-85. doi: 10.1161/01.cir.99.6.779.
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, Syvanne 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. No abstract available.
EUROASPIRE I and II Group; European Action on Secondary Prevention by Intervention to Reduce Events. Clinical reality of coronary prevention guidelines: a comparison of EUROASPIRE I and II in nine countries. EUROASPIRE I and II Group. European Action on Secondary Prevention by Intervention to Reduce Events. Lancet. 2001 Mar 31;357(9261):995-1001. doi: 10.1016/s0140-6736(00)04235-5.
Other Identifiers
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E35E09000880002
Identifier Type: -
Identifier Source: org_study_id
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