Ekvasis of Atorvastatin (Antorcin®) Treatment in Patients With Acute Cardiovascular Events (EKVASIS)
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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. |
- 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
- 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
- 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.
| Estimated Enrollment: | 900 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (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 |
Patients on atorvastatin treatment after hospitalization due to cardiovascular events
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| 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 | |
| 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:
| 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: | May 10, 2013 |
| 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 Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013