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

NCT02522182 | Completed

• 1 other identifier: E35E09000880002
• Study Type: interventional
• Target: 2,060
• Locations: 1 country
• Sites: 7

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.

Conditions

Acute Coronary Syndrome

Keywords

Cardiovascular Secondary Prevention; Nurse's Role

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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

  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.

  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.

  24 months

• Major adverse events

  Composite of cardiovascular mortality, non-fatal reinfarction, non-fatal stroke

  5 years

Secondary Outcomes (5)

• Clinical endpoints

  5 years

• Clinical endpoints

  5 years

• Clinical endpoints

  5 years

• Clinical endpoints

  5 years

• Clinical endpoints

  5 years

Study Arms (2)

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.

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

Behavioral: Usual Treatment

Interventions

Nurse-led Intensive Secondary Prevention Programme BEHAVIORAL

Information related to intervention description have been already included in arm/group description

Intensive Secondary Prevention Programme

Usual Treatment BEHAVIORAL

Information related to intervention description have been already included in arm/group description

Usual Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma: lead

Study Sites (7)

Ospedale di Baggiovara

Baggiovara, Modena, 41126, Italy

Location

Ospedale Ramazzini di Carpi

Carpi, Modena, 41012, Italy

Location

Ospedale di Vaio

Fidenza, Parma, 43036, Italy

Location

Azienda Ospedaliero-Universitaria di Parma

Parma, Parma, 43126, Italy

Location

Ospedale Guglielmo da Saliceto

Piacenza, Piacenza, 29121, Italy

Location

Ospedale Sant'Anna

Castelnovo ne' Monti, Reggio Emilia, Italy

Location

Ospedale Civile di Guastalla

Guastalla, Reggio Emilia, 42020, Italy

Location

Related Publications (10)

• 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.

  PMID: 3945130 BACKGROUND

• 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.

  PMID: 19286092 BACKGROUND

• 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.

  PMID: 20805110 BACKGROUND

• 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.

  PMID: 16263889 BACKGROUND

• 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.

  PMID: 18555911 BACKGROUND

• 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.

  PMID: 19001195 BACKGROUND

• 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.

  PMID: 23813851 BACKGROUND

• 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.

  PMID: 9989963 BACKGROUND

• 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.

  PMID: 22555213 BACKGROUND

• 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.

  PMID: 11293642 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Diego Ardissino, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: August 13, 2015
• Study Start: October 1, 2012
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: March 26, 2025

Record last verified: 2023-08

Locations

IT (7)