Clinical trial NCT02927808: Motivational Interviewing to Support LDL-C Therapeutic Goals and Lipid-Lowering Therapy Compliance in Patients With Acute Coronary Syndromes: a Prospective Randomized Clinical Study
Official title: Motivational Interviewing to Support LDL-C Therapeutic Goals and Lipid-Lowering Therapy Compliance in Patients With Acute Coronary Syndromes: a Prospective Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Motivational Interviewing
LDL-C
LDL target
Medication adherence
Lead sponsor: AHEPA University Hospital
Sponsor class: OTHER
First posted: 2016-10-07
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will investigate the impact of motivational interviewing in achieving low-density lipoprotein cholesterol therapeutic targets in patients with acute coronary syndromes.

Detailed description: To determine whether a strategy of enhanced information about the risks of high plasma low-density lipoprotein cholesterol (LDL-C) and the importance of lipid-lowering medication together with close follow-up and motivational interviewing is superior than usual care in achieving LDL-C therapeutic targets, as set by current practice guidelines (LDL-C \<70 mg/dL or \>50% reduction from baseline LDL-C) in patients with acute coronary syndromes.

Eligibility criteria: Inclusion Criteria:

* Subject hospitalized for acute coronary syndrome (STEMI, NTEMI or unstable angina)
* Subject currently on lipid-lowering therapy or prescribed lipid-lowering therapy at hospital discharge (statins and/or other agents)
* Subject who is 18 years or older
* Subject or legally authorized representative who is willing and capable of providing informed consent, participating in all associated study activities

Exclusion Criteria:

* Subject unable to communicate via telephone for study interviewing
* Subject with contraindication to statin therapy
* Subject with any medical disorder that would interfere with completion or evaluation of clinical study results

Primary outcomes:
measure: Achievement of low-density lipoprotein cholesterol therapeutic goal, as specified by current practice guidelines (LDL-C <70 mg/dL or >50% reduction from baseline LDL-C)
timeFrame: 12 months after discharge from hospital
Secondary outcomes:
measure: Overall adherence to lipid-lowering regimen, reported as both a continuous and a binary outcome, by using the 4-item Morisky Medication-Taking Adherence Scale
timeFrame: 12 months after discharge from hospital
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: AHEPA University Hospital
Study officials:
References:
citation: Kourti O, Konstantas O, Farmakis ITau, Zafeiropoulos S, Psarakis G, Vrana E, Baroutidou A, Graidis S, Touriki AV, Tsolakidis C, Spyridaki K, Psathas T, Daniilidou A, Karvounis H, Giannakoulas G. Potent P2Y12 inhibitors versus clopidogrel to predict adherence to antiplatelet therapy after an acute coronary syndrome: insights from IDEAL-LDL. Rev Cardiovasc Med. 2022 Mar 3;23(3):81. doi: 10.31083/j.rcm2303081.
citation: Zafeiropoulos S, Farmakis I, Kartas A, Arvanitaki A, Pagiantza A, Boulmpou A, Tampaki A, Kosmidis D, Nevras V, Markidis E, Papadimitriou I, Vlachou A, Arvanitakis K, Miyara SJ, Ziakas A, Molmenti EP, Kassimis G, Zanos S, Karvounis H, Giannakoulas G. Reinforcing adherence to lipid-lowering therapy after an acute coronary syndrome: A pragmatic randomized controlled trial. Atherosclerosis. 2021 Apr;323:37-43. doi: 10.1016/j.atherosclerosis.2021.03.013. Epub 2021 Mar 17.