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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier:
NCT01770210
First received: January 14, 2013
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Cardiovascular Disorders
Drug: Patients on atorvastatin treatment

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Multicenter, Open-label, 30-week Observational Clinical Study to Examine the Progress of Patients After Leaving the Cardiology Clinic or Unit Due to Acute Cardiovascular Event.

Resource links provided by NLM:


Further study details as provided by Elpen Pharmaceutical Co. Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: 0 months, 1-1,5 months, 4-4,5 months, 7-7,5 months ] [ Designated as safety issue: Yes ]
    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

  • Change of LDL-C, HDL-C, T-CHOL from baseline to the end of the study by atorvastatin dosage scheme [ Time Frame: 0 months, 1-1,5 months, 4-4,5 months, 7-7,5 months ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Measurement of days without treatment - Patients' compliance [ Time Frame: 0 months, 1-1,5 months, 4-4,5 months, 7-7,5 months ] [ Designated as safety issue: No ]
    The investigation of compliance to treatment (days without taking medication, changing the time of intake) and its correlation with the achievement of target lipid levels (LDL-C, HDL-C, T-CHOL) in blood plasma of the studied patients

  • Number of Adverse Events during study duration [ Time Frame: 0 (baseline), 7-7,5 months ] [ Designated as safety issue: Yes ]
    Safety evaluation by adverse events reporting


Other Outcome Measures:
  • Changes in other than lipids hematological and biochemical parameters from baseline until the end of the study [ Time Frame: 0, 1-1,5 months, 4-4,5 months, 7-7,5 months ] [ Designated as safety issue: Yes ]
    The reporting of hematological and biochemical tests where conducted at each hospital center, as part of their standard clinical practice

  • Number of participants per dyslipidemia categorization [ Time Frame: 0 months (baseline) ] [ Designated as safety issue: Yes ]
    The determination of dyslipidemia class it belongs to each patient in order to assess the efficacy of atorvastatin administered.


Enrollment: 670
Study Start Date: February 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cardiovascular events
Patients on atorvastatin treatment hospitalised due to cardiovascular events
Drug: Patients on atorvastatin treatment
Statins Therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients on atorvastatin treatment after hospitalization due to cardiovascular events

Criteria

Inclusion Criteria:

  • Outpatients (External Ambulatory) Patients.
  • Male or female patients
  • 18 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770210

Locations
Greece
Rio University Hospital
Patras, Achaia, Greece
Evagelismos General State Hospital
Athens, Attica, Greece
Euroclinic Private Hospital
Athens, Attica, Greece
Gennimatas General State Hospital
Athens, Attica, Greece
Konstantopoulio General Hospital
Nea Ionia, Attica, Greece
General State Hospital
Polygyros, Chalkidiki, Greece
University Hospital
Heraklion, Crete, Greece
General State Hospital
Rhodes, Dodecanese, Greece
General State Hospital
Kalamata, Messinia, Greece
General State Hospital
Edesssa, Pella, Greece
University Hospital
Larisa, Thessaly, Greece
Sismanogleio General State Hospital
Athens, Greece
Hippokration General Hospital
Athens, Greece
General State Hospital
Nikaia Piraeus, Greece
Tzannion General State Hospital
Piraeus, Greece
Papageorgiou Hospital
Thessaloniki, Greece
424 Military Hospital
Thessaloniki, Greece
Sponsors and Collaborators
Elpen Pharmaceutical Co. Inc.
Investigators
Principal Investigator: 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
  More Information

Publications:
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

Responsible Party: Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier: NCT01770210     History of Changes
Other Study ID Numbers: 2012-ATR-EL-34
Study First Received: January 14, 2013
Last Updated: August 18, 2014
Health Authority: Greece: National Organization of Medicines

Keywords provided by Elpen Pharmaceutical Co. Inc.:
hypercholesterolemia
atorvastatin
cardiovascular events

Additional relevant MeSH terms:
Cardiovascular Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014