Ekvasis of Atorvastatin (Antorcin®) Treatment in Patients With Acute Cardiovascular Events

NCT01770210 | Completed

• 1 other identifier: 2012-ATR-EL-34
• Study Type: observational
• Target: 670
• Locations: 1 country
• Sites: 17

Brief Summary

In western societies hypercholesterolemia is one of the major and independent factors that predispose to cardiovascular disease and death from them. According to the clinical study ATTICA, conducted during the years 2001-2002, in which randomized 1514 men and 1528 women, rates of hypercholesterolemia observed in a sample of urban population was 39% for men and 37% women . The prevalence in the corresponding U.S. epidemiological study NIANES was 52% for men and 49% women. The relationship between cholesterol, lipid-lowering therapy and risk of cardiovascular disease appears to be quite clear in the secondary prevention trials, the 4S (Scandinavian Simvastatin Survival Study), CARE (Cholesterol And Recurrent Events) and LIPID (Long-term Intervention with Pravastatin in Ischemic Disease) which showed the benefits of lowering LDL cholesterol in patients with coronary artery disease. Despite these remarkable results, studies were secondary prevention as a major shortcoming, the lack of patients with acute coronary events. This gap came to cover the study MIRACL (Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering). In MIRACL study , atorvastatin 80 mg was evaluated in 3,086 patients (atorvastatin n = 1.538, placebo n = 1.548), acute coronary syndrome (myocardial infarction without Q-wave or unstable angina). Treatment was initiated during the acute phase after hospital admission and lasted for a period of 16 weeks. Treatment with atorvastatin 80 mg / day increased the latency of the combined primary endpoint, defined as death from any cause, nonfatal myocardial infarction, resuscitated cardiac arrest, or angina with objective evidence of myocardial ischemia requiring admission to hospital, indicating a risk reduction of 16% (p = 0,048). This was mainly due to a 26% reduction in re-hospitalization for angina with objective evidence of myocardial ischemia. The other secondary endpoints were not statistically significant by themselves (total: placebo: 22.2%, Atorvastatin: 22.4%). Statins by reducing coronary syndromes, it appears that contribute to reducing the incidence of cardiovascular diseases. This is exactly what was observed in 4S, in which the incidence of chronic heart failure (CHF) during follow-up was 10.3% for those who received placebo and 8.3% in the simvastatin group, a finding which translates 19% reduction in heart failure (P \<0,015) nationwide with the appearance episode (event) CV.

Conditions

Cardiovascular Disorders

Keywords

hypercholesterolemia; atorvastatin; cardiovascular events

Outcome Measures

Primary Outcomes (2)

• Change of lipids (LDL-C, HDL-C, T-CHOL)levels from baseline to the end of the studyCHOL) plasma blood Evaluation of atorvastatin (Antorcin) treatment per study subgroup

  The evaluation of atorvastatin treatment to all patients with cardiovascular events and separate the two subgroups (diabetes type II patients with metabolic syndrome) in order to achieve the level of lipids (LDL-C, HDL-C, T-CHOL) plasma blood

  0 months, 1-1,5 months, 4-4,5 months, 7-7,5 months

• Change of LDL-C, HDL-C, T-CHOL from baseline to the end of the study by atorvastatin dosage scheme

  Achieving the level of lipids (LDL-C, HDL-C, T-CHOL) in blood plasma of patients in the atorvastatin dosage: those who received the 40 mg dose and those who received a dose of 80 mg

  0 months, 1-1,5 months, 4-4,5 months, 7-7,5 months

Secondary Outcomes (2)

• Measurement of days without treatment - Patients' compliance

  0 months, 1-1,5 months, 4-4,5 months, 7-7,5 months

• Number of Adverse Events during study duration

  0 (baseline), 7-7,5 months

Other Outcomes (2)

• Changes in other than lipids hematological and biochemical parameters from baseline until the end of the study

  0, 1-1,5 months, 4-4,5 months, 7-7,5 months

• Number of participants per dyslipidemia categorization

  0 months (baseline)

Study Arms (1)

Cardiovascular events

Patients on atorvastatin treatment hospitalised due to cardiovascular events

Drug: Patients on atorvastatin treatment

Interventions

Patients on atorvastatin treatment DRUG

Statins Therapy

Cardiovascular events

Eligibility Criteria

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

Study Population

Patients on atorvastatin treatment after hospitalization due to cardiovascular events

You may qualify if:

• Outpatients (External Ambulatory) Patients.
• Male or female patients
• to 99 years
• Patients with Hypercholesterolemia
• Patients with and without treatment with statin
• Patients enrolled in any of the study sites with acute cardiovascular event
• Patients discharged with study medication (Antorcin ®)
• Patients who have agreed and signed the consent form for the recording and processing of their personal data.

You may not qualify if:

• Patients under 18 and over 99 years.
• Women in pregnancy or lactation period
• Patients enrolled in any of the study sites for any reason other than an acute cardiovascular event
• Patients who discharged and take another statin drug formulation other than the study drug formulation (Antorcin ®)
• Patients who have not consented and signed the consent form for the recording and processing of their personal data.

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (17)

Rio University Hospital

Pátrai, Achaia, Greece

Location

Euroclinic Private Hospital

Athens, Attica, Greece

Location

Evagelismos General State Hospital

Athens, Attica, Greece

Location

Gennimatas General State Hospital

Athens, Attica, Greece

Location

Konstantopoulio General Hospital

Nea Ionia, Attica, Greece

Location

General State Hospital

Polygyros, Chalkidiki, Greece

Location

University Hospital

Heraklion, Crete, Greece

Location

General State Hospital

Rhodes, Dodecanese, Greece

Location

General State Hospital

Kalamata, Messinia, Greece

Location

General State Hospital

Edesssa, Pella, Greece

Location

424 Military Hospital

Thessaloniki, Thessaloniki, Greece

Location

Papageorgiou Hospital

Thessaloniki, Thessaloniki, Greece

Location

University Hospital

Larissa, Thessaly, Greece

Location

Hippokration General Hospital

Athens, Greece

Location

Sismanogleio General State Hospital

Athens, Greece

Location

General State Hospital

Nikaia Piraeus, Greece

Location

Tzannion General State Hospital

Piraeus, Greece

Location

Related Publications (14)

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  PMID: 20425272 BACKGROUND

• Benner JS, Glynn RJ, Mogun H, Neumann PJ, Weinstein MC, Avorn J. Long-term persistence in use of statin therapy in elderly patients. JAMA. 2002 Jul 24-31;288(4):455-61. doi: 10.1001/jama.288.4.455.

  PMID: 12132975 BACKGROUND

• Jackevicius CA, Mamdani M, Tu JV. Adherence with statin therapy in elderly patients with and without acute coronary syndromes. JAMA. 2002 Jul 24-31;288(4):462-7. doi: 10.1001/jama.288.4.462.

  PMID: 12132976 BACKGROUND

• Simons LA, Levis G, Simons J. Apparent discontinuation rates in patients prescribed lipid-lowering drugs. Med J Aust. 1996 Feb 19;164(4):208-11. doi: 10.5694/j.1326-5377.1996.tb94138.x.

  PMID: 8604188 BACKGROUND

• Larsen J, Andersen M, Kragstrup J, Gram LF. High persistence of statin use in a Danish population: compliance study 1993-1998. Br J Clin Pharmacol. 2002 Apr;53(4):375-8. doi: 10.1046/j.1365-2125.2002.01563.x.

  PMID: 11966668 BACKGROUND

• Frolkis JP, Pearce GL, Nambi V, Minor S, Sprecher DL. Statins do not meet expectations for lowering low-density lipoprotein cholesterol levels when used in clinical practice. Am J Med. 2002 Dec 1;113(8):625-9. doi: 10.1016/s0002-9343(02)01303-7.

  PMID: 12505111 BACKGROUND

• Miettinen TA, Pyorala K, Olsson AG, Musliner TA, Cook TJ, Faergeman O, Berg K, Pedersen T, Kjekshus J. Cholesterol-lowering therapy in women and elderly patients with myocardial infarction or angina pectoris: findings from the Scandinavian Simvastatin Survival Study (4S). Circulation. 1997 Dec 16;96(12):4211-8. doi: 10.1161/01.cir.96.12.4211.

  PMID: 9416884 BACKGROUND

• S Carter D Taylor. A Question of Choice: Compliance in Medicine Taking. Medicines Partnership 2003, www.medicines-partnership.org

  BACKGROUND

• Seiki S, Frishman WH. Pharmacologic inhibition of squalene synthase and other downstream enzymes of the cholesterol synthesis pathway: a new therapeutic approach to treatment of hypercholesterolemia. Cardiol Rev. 2009 Mar-Apr;17(2):70-6. doi: 10.1097/CRD.0b013e3181885905.

  PMID: 19367148 BACKGROUND

• Wei L, Wang J, Thompson P, Wong S, Struthers AD, MacDonald TM. Adherence to statin treatment and readmission of patients after myocardial infarction: a six year follow up study. Heart. 2002 Sep;88(3):229-33. doi: 10.1136/heart.88.3.229.

  PMID: 12181210 BACKGROUND

• Heeschen C, Hamm CW, Laufs U, Snapinn S, Bohm M, White HD; Platelet Receptor Inhibition in Ischemic Syndrome Management (PRISM) Investigators. Withdrawal of statins increases event rates in patients with acute coronary syndromes. Circulation. 2002 Mar 26;105(12):1446-52. doi: 10.1161/01.cir.0000012530.68333.c8.

  PMID: 11914253 BACKGROUND

• Thomas M, Mann J. Increased thrombotic vascular events after change of statin. Lancet. 1998 Dec 5;352(9143):1830-1. doi: 10.1016/S0140-6736(05)79893-7. No abstract available.

  PMID: 9851392 BACKGROUND

• Guidelines of the Hellenic Society of Atherosclerosis for the diagnosis and treatment of dyslipidemia M. Elisaf, Ch. Pitsavos, E. Liberopoulos, V. Athyros Hellenic Journal of Atherosclerosis 2(3):163-168, 06/04/2011

  BACKGROUND

• Davidson MH. Clinical significance of statin pleiotropic effects: hypotheses versus evidence. Circulation. 2005 May 10;111(18):2280-1. doi: 10.1161/01.CIR.0000167560.93138.E7. No abstract available.

  PMID: 15883224 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Antonis Ziakas, Ass Professor

  AHEPA hospital of Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

• Charalampos Karvounis, Professor

  AHEPA hospital of Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

• Georgios Maligos, Registrat A

  Papanikolaou hospital of Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

• Ioannis Kanonidis, Professor

  Hippokration hospital of Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

• Dimitrios Psyropoulos, Director

  Gennimatas hospital of Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

• Ioannis Vogiatzis, Director

  Hospital of Veria, Greece

  PRINCIPAL INVESTIGATOR

• Pantelis Kligatsis, Director

  Hospital of Florina, Greece

  PRINCIPAL INVESTIGATOR

• David Symeonidis, Director

  Hospital of Kavala, Greece

  PRINCIPAL INVESTIGATOR

• Nikolaos Theodoridis, Director

  Hospital of Drama, Greece

  PRINCIPAL INVESTIGATOR

• Stylianos Lampropoulos, Director

  Hospital of Ptolemaida, Greece

  PRINCIPAL INVESTIGATOR

• Georgios Spyromitros, Director

  Hospital of Katerini, Greece

  PRINCIPAL INVESTIGATOR

• Ioannis Tsounos, Director

  Agios Pavlos hospital of Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

• Vlasis Pyrgakis, Director

  George Gennimatas hospital of Athens, Greece

  PRINCIPAL INVESTIGATOR

• Andreas Tsellios, Registrat

  NIMTS hospital of Athens, Greece

  PRINCIPAL INVESTIGATOR

• Ioannis Kalikazaros, Director

  Hippokration hospital of Athens, Greece

  PRINCIPAL INVESTIGATOR

• Dimitrios Richter, Director

  Euroclinic of Athens, Greece

  PRINCIPAL INVESTIGATOR

• Emmanouel Kallieris, Associate Director

  Metropolitan hospital of Piraeus, Greece

  PRINCIPAL INVESTIGATOR

• Apostolos Katsivas, Director

  Red Cross Hospital of Athens, Greece

  PRINCIPAL INVESTIGATOR

• Stefanos Foussas, Director

  Tzannion hospital of Piraeus, Greece

  PRINCIPAL INVESTIGATOR

• Dimitrios Tziakas, Ass. Professor

  University Hospital of Alexandroupolis, Greece

  PRINCIPAL INVESTIGATOR

• Konstantinos Papaioannou, Director

  Hospital of Polygyros, Greece

  PRINCIPAL INVESTIGATOR

• Ioannis Styliadis, Director

  Papageorgiou Hospital of Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

• Pantelis Makridis, Director

  Hospital of Edessa, Greece

  PRINCIPAL INVESTIGATOR

• Panayotis Kyriakidis, Director

  424 military hospital of Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

• Georgios Karakostas, Director

  Hospital of Kilkis, Greece

  PRINCIPAL INVESTIGATOR

• Vasilios Vasilikos, Ass Professor

  Hippokration hospital of Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

• Sotirios Patsilinakos, Director

  Konstantopoulio General Hospital of Athens

  PRINCIPAL INVESTIGATOR

• Dimitrios Sionis, Director

  Sismanogleio General Hospital of Athens

  PRINCIPAL INVESTIGATOR

• Antonios Sideris, Director

  Evagelismos General Hospital of Athens

  PRINCIPAL INVESTIGATOR

• Athanasios Manolis, Director

  Asklepiion General Hospital of Voula

  PRINCIPAL INVESTIGATOR

• Chrysostomos Oikonomou, Director

  Laikon General Hospital of Athens

  PRINCIPAL INVESTIGATOR

• Panagiotis Pentzeridis, Director

  General State Hospital of Nikaia, Piraeus

  PRINCIPAL INVESTIGATOR

• Athanasios Pras, Director

  General State Hospital of Chania, Crete

  PRINCIPAL INVESTIGATOR

• Alkiviadis Dermitzakis, Director

  Venizeleio General State Hospital of Heraklion, Crete

  PRINCIPAL INVESTIGATOR

• Panagiotis Vardas, Professor

  University Hospital of Heraklion, Crete

  PRINCIPAL INVESTIGATOR

• Dimitrios Alexopoulos, Professor

  Rio University Hospital of Patras

  PRINCIPAL INVESTIGATOR

• Andreas Mazarakis, Director

  Agios Andreas General State Hospital of Patras

  PRINCIPAL INVESTIGATOR

• Antonios Draganigos, Director

  General State Hospital of Corfu

  PRINCIPAL INVESTIGATOR

• Filippos Tryposkiadis, Professor

  University Hospital of Larisa, Thessaly

  PRINCIPAL INVESTIGATOR

• Spyridon Zombolos, Director

  General State Hospital of Kalamata

  PRINCIPAL INVESTIGATOR

• Dimitrios Platogiannis, Director

  General State Hospital of Trikala

  PRINCIPAL INVESTIGATOR

• Panagiotis Stasinos, Director

  General State Hospital of Ierapetra, Crete

  PRINCIPAL INVESTIGATOR

• Nikitas Moschos, Director

  General State Hospital of Rhodes

  PRINCIPAL INVESTIGATOR

• Chrysostomos Dilanas, Director

  General State Hospital of Korinthos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 17, 2013
• Study Start: February 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 19, 2014

Record last verified: 2014-08

Locations

GR (17)