Acute Coronary SyndromeALLEPRENCT02522182
ALLiance for sEcondary PREvention After an Episode of Acute Coronary Syndrome (ALLEPRE)
A study testing Nurse-led Intensive Secondary Prevention Programme and Usual Treatment in people with Acute Coronary Syndrome, run by Azienda Ospedaliero-Universitaria di Parma at 7 sites in Italy.
Trial 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. 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?
- Nurse-led Intensive Secondary Prevention Programme and Usual Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,060 participants
- Where
- 7 sitesItaly
- Study dates
- Oct 2012to 31 Jan 2025
- Phase
- Interventional
- 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
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Ospedale di Baggiovara
Baggiovara, Modena, 41126
Ospedale Ramazzini di Carpi
Carpi, Modena, 41012
Ospedale Sant'Anna
Castelnovo ne' Monti, Reggio Emilia
Ospedale di Vaio
Fidenza, Parma, 43036
Ospedale Civile di Guastalla
Guastalla, Reggio Emilia, 42020
Azienda Ospedaliero-Universitaria di Parma
Parma, Parma, 43126
Ospedale Guglielmo da Saliceto
Piacenza, Piacenza, 29121
About this study
Official title: ALLiance for sEcondary PREvention After an Episode of Acute Coronary Syndrome. The ALLEPRE Trial: a Fully Nurse-led Intensive Intervention Programme
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.
Read the detailed description
ALLEPRE enrols a population of residents in Emilia Romagna with a diagnosis of ACS (unstable angina, non-ST segment elevation myocardial infarction, ST segment elevation myocardial infarction) who were admitted to the specialist cardiological departments of the participating centres up to 20 days after the index event.
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
- Acute Coronary Syndrome
- Being tested
- Nurse-led Intensive Secondary Prevention Programme, Usual Treatment
- Keywords
- Cardiovascular Secondary Prevention, Nurse's Role
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led Intensive Secondary Prevention ProgrammeBehavioural
Information related to intervention description have been already included in arm/group description
Usual TreatmentBehavioural
Information related to intervention description have been already included in arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Intensive Secondary Prevention Programme | Experimental | 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. Receives: Behavioral: Nurse-led Intensive Secondary Prevention Programme |
| Usual Treatment | Active comparator | The patients randomised to the control group will follow the Usual Treatment for secondary prevention of the hospital to which they were admitted Receives: Behavioral: Usual Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the degree of adherence to the goals concerning risk factors, lifestyle modifications and pharmacological therapy.
Adherence to the goals of classic cardiovascular risk factors:
- number of patients (nop) with systolic blood pressure <140 mmHg, divided by total nop.
Measured: 24 months
The difference in the degree of adherence to the goals concerning risk factors, lifestyle modifications and pharmacological therapy.
Adherence to the goals of classic cardiovascular risk factors:
- nop with LDL cholesterol <70 mg/dL, divided by total nop.
Measured: 24 months
The difference in the degree of adherence to the goals concerning risk factors, lifestyle modifications and pharmacological therapy.
Adherence to the goals of classic cardiovascular risk factors:
- number of non-smokers, divided by the total nop.
Measured: 24 months
The difference in the degree of adherence to the goals concerning risk factors, lifestyle modifications and pharmacological therapy.
Adherence to the goals of classic cardiovascular risk factors:
- nop with HbAC1 <7%, divided by total nop.
Measured: 24 months
The difference in the degree of adherence to the goals concerning risk factors, lifestyle modifications and pharmacological therapy.
The number of patients with the target body mass index (18-24.9) divided by the total nop.
Measured: 24 months
The difference in the degree of adherence to the goals concerning risk factors, lifestyle modifications and pharmacological therapy.
Adherence to life style modifications:
- Number of patients eating at least 5 servings friut/vegetable/day divided by total nop at month 24.
Measured: 24 months
The difference in the degree of adherence to the goals concerning risk factors, lifestyle modifications and pharmacological therapy.
The number of patients eating at least 2 fish servings/wk divided by the total
Measured: 24 months
The difference in the degree of adherence to the goals concerning risk factors, lifestyle modifications and pharmacological therapy.
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.
Measured: 24 months
The difference in the degree of adherence to the goals concerning risk factors, lifestyle modifications and pharmacological therapy.
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.
Measured: 24 months
Major adverse events
Composite of cardiovascular mortality, non-fatal reinfarction, non-fatal stroke
Measured: 5 years
Secondary outcomes (5)
Clinical endpoints
a composite of cardiovascular mortality, nonfatal reinfarction, and nonfatal troke and myocardial ischemia-driven revascularization.
Measured: 5 years
Clinical endpoints
non-fatal reinfarction
Measured: 5 years
Clinical endpoints
non-fatal stroke
Measured: 5 years
Clinical endpoints
cardiovascular mortality
Measured: 5 years
Clinical endpoints
All-cause mortality
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startOct 2012
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,060 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Ardissino, Azienda Ospedaliero-Universitaria di Parma
- Investigators
- Diego Ardissino, MD, Principal investigator, Azienda Ospedaliero-Universitaria di Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522182
- Sponsor's protocol ID
- E35E09000880002
- Acronym
- ALLEPRE
- Status last verified
- Aug 2023
- First submitted
- 21 Jul 2015
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 3945130Kotseva 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.
PubMed 19286092Fox 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.
PubMed 20805110Clark 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.
PubMed 16263889Wood 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.
PubMed 18555911Giannuzzi 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.
PubMed 19001195Jorstad 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.
PubMed 23813851de 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.
PubMed 9989963Perk 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.
PubMed 22555213EUROASPIRE 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.
PubMed 11293642
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALLiance for sEcondary PREvention After an Episode of Acute Coronary Syndrome. The ALLEPRE Trial: a Fully Nurse-led Intensive Intervention Programme
- ClinicalTrials.gov ID
- NCT02522182
- Acronym / sponsor ID
- ALLEPRE / E35E09000880002
- Conditions
- Acute Coronary Syndrome
- Keywords
- Cardiovascular Secondary Prevention, Nurse's Role
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,060 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ALLEPRE enrols a population of residents in Emilia Romagna with a diagnosis of ACS (unstable angina, non-ST segment elevation myocardial infarction, ST segment elevation myocardial infarction) who were admitted to the specialist cardiological departments of the participating centres up to 20 days after the index event.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Secondary Prevention Programme | Experimental | Behavioral: Nurse-led Intensive Secondary Prevention ProgrammeThe 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. |
| Usual Treatment | Active comparator | Behavioral: Usual TreatmentThe patients randomised to the control group will follow the Usual Treatment for secondary prevention of the hospital to which they were admitted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led Intensive Secondary Prevention ProgrammeInformation related to intervention description have been already included in arm/group description | Behavioural | Intensive Secondary Prevention Programme |
| Usual TreatmentInformation related to intervention description have been already included in arm/group description | Behavioural | Usual Treatment |
Primary outcome
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.
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.
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.
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.
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.
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.
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
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.
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.
Major adverse events
Time frame: 5 years
Composite of cardiovascular mortality, non-fatal reinfarction, non-fatal stroke
5 secondary outcomes
Clinical endpoints
Time frame: 5 years
Clinical endpoints
Time frame: 5 years
Clinical endpoints
Time frame: 5 years
Clinical endpoints
Time frame: 5 years
Clinical endpoints
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Results publication: PubMed 3945130Morisky 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.
- Results publication: PubMed 19286092Kotseva 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.
- Results publication: PubMed 20805110Fox 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.
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- Results publication: PubMed 18555911Wood 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.
- Results publication: PubMed 19001195Giannuzzi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego Ardissino, MD principal investigator
Azienda Ospedaliero-Universitaria di Parma
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led Intensive Secondary Prevention Programme and Usual Treatment in people with Acute Coronary Syndrome, run by Azienda Ospedaliero-Universitaria di Parma at 7 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 1 inclusion and 1 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 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
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?
The difference in the degree of adherence to the goals concerning risk factors, lifestyle modifications and pharmacological therapy. (time frame: 24 months). The study lists 10 primary outcomes in all. 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 NCT02522182, which also lists 10 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 26 Mar 2025.