Effect of Statins on Lipid Levels Following the First Acute Coronary Event (MK-0000-204) (REMAINS)
30 stycznia 2017 zaktualizowane przez: Merck Sharp & Dohme LLC
Dyslipidemia: REsidual and Mixed Abnormalities IN Spite of Statin Therapy: The Dyslipidemia REMAINS Study: A Multicenter, Prospective, Observational Study of Lipid Profiles and Treatment Patterns at Presentation and After 12 Weeks of Statin Therapy Among Indian Adults Presenting With First Coronary Event
The current study is proposed to investigate the pattern of dyslipidemia and of lipid treatment practices in patients in India experiencing their first acute cardiovascular event and the extent of residual dyslipidemia after 12 weeks of treatment with statins.
Dyslipidemia definitions are per the National Cholesterol Education Program - Adult Treatment Panel III (NCEP-ATP III).
Przegląd badań
Status
Zakończony
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
635
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
35 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
Patients experiencing their first acute coronary event who are admitted to participating tertiary cardiac care centers in India will potentially be eligible for the study.
Opis
Inclusion Criteria:
- Currently admitted with a confirmed diagnosis of first acute coronary event (STEMI/NSTEMI/Unstable Angina)
- Access to medical records covering the entire study period, and availability of data required for the study
- Potential to collect blood sample within 24 hours of onset for symptoms
- Considered for initiation/maintenance/modification of statin therapy before discharge from hospital
- Willing to comply with the study requirements
Exclusion Criteria:
- Participating in a clinical trial or any type of other clinical study involving therapeutic intervention or otherwise failing to consent to interview
- Known inherited disorder of lipoprotein metabolism
- History of hypothyroidism, nephrotic syndrome, chronic alcoholism, Cushing syndrome
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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Participants
Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Total Cholesterol (TC) Levels at First Acute Coronary Event
Ramy czasowe: At hospital presentation (Day 1)
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At the time of hospital admission for a first acute coronary event, the TC levels of eligible participants were taken.
This level was considered the baseline value.
A TC level of >240 mg/dL is considered an abnormal lipid value (dyslipidemia).
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At hospital presentation (Day 1)
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Low-Density Lipoprotein Cholesterol (LDL-C) Levels at First Acute Coronary Event
Ramy czasowe: At hospital presentation (Day 1)
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At the time of hospital admission for a first acute coronary event, the LDL-C levels of eligible participants were taken.
This level was considered the baseline value.
A LDL-C level of >70 mg/dL is considered an abnormal lipid value (dyslipidemia).
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At hospital presentation (Day 1)
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High-Density Lipoprotein Cholesterol (HDL-C) Levels at First Acute Coronary Event
Ramy czasowe: At hospital presentation (Day 1)
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At the time of hospital admission for a first acute coronary event, the HDL-C levels of eligible participants were taken.
This level was considered the baseline value.
A HDL-C level of <40 mg/dL is considered an abnormal lipid value (dyslipidemia).
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At hospital presentation (Day 1)
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Triglycerides (TG) Levels at First Acute Coronary Event
Ramy czasowe: At hospital presentation (Day 1)
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At the time of hospital admission for a first acute coronary event, the TG levels of eligible participants were taken.
This level was considered the baseline value.
A TG level of >150 mg/dL is considered an abnormal lipid value (dyslipidemia).
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At hospital presentation (Day 1)
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Change From Baseline in TC Levels After Treatment
Ramy czasowe: Baseline and at Week 12
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TC levels were measured after 12 weeks of treatment with a statin.
The change from baseline was calculated as the difference between baseline and Week 12 values.
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Baseline and at Week 12
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Change From Baseline in LDL-C Levels After 12 Weeks of Treatment With Statins
Ramy czasowe: Baseline and at Week 12
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LDL-C levels were measured after 12 weeks of treatment with a statin.
The change from baseline was calculated as the difference between baseline and Week 12 values.
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Baseline and at Week 12
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Change From Baseline in HDL-C Levels After 12 Weeks of Treatment With Statins
Ramy czasowe: Baseline and at Week 12
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HDL-C levels were measured after 12 weeks of treatment with a statin.
The change from baseline was calculated as the difference between baseline and Week 12 values.
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Baseline and at Week 12
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Change From Baseline in TG Levels After 12 Weeks of Treatment With Statins
Ramy czasowe: Baseline and at Week 12
|
TG levels were measured after 12 weeks of treatment with a statin.
The change from baseline was calculated as the difference between Baseline and Week 12 values.
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Baseline and at Week 12
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Percentage of Participants Who Achieved Target Lipid Levels for LDL-C But Did Not Achieve Target Lipid Levels for HDL-C and TG After 12 Weeks of Treatment With Statins
Ramy czasowe: Week 12
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The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins.
Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
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Week 12
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Percentage of Participants Who Achieved Target Lipid Levels for TG and LDL-C But Did Not Achieve Target Lipid Levels for HDL-C After 12 Weeks of Treatment With Statins
Ramy czasowe: Week 12
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The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins.
Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
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Week 12
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Percentage of Participants Who Achieved Target Lipid Levels of HDL-C and LDL-C But Did Not Achieve Target Lipid Levels for TG After 12 Weeks of Treatment With Statins
Ramy czasowe: Week 12
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The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins.
Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
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Week 12
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Percentage of Participants Who Did Not Achieve Target Lipid Levels for LDL-C, HDL-C, and TG After 12 Weeks of Treatment With Statins
Ramy czasowe: Week 12
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The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins.
Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
|
Week 12
|
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Percentage of Participants Who Achieved Target Lipid Levels for TG But Did Not Achieve Target Lipid Levels for HDL-C and LDL-C After 12 Weeks of Treatment With Statins
Ramy czasowe: Week 12
|
The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins.
Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
|
Week 12
|
|
Percentage of Participants Who Achieved Target Lipid Levels of HDL-C But Did Not Achieve Target Lipid Levels for TG and LDL-C After 12 Weeks of Treatment With Statins
Ramy czasowe: Week 12
|
The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins.
Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
|
Week 12
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 sierpnia 2010
Zakończenie podstawowe (Rzeczywisty)
1 grudnia 2012
Ukończenie studiów (Rzeczywisty)
1 grudnia 2012
Daty rejestracji na studia
Pierwszy przesłany
13 sierpnia 2010
Pierwszy przesłany, który spełnia kryteria kontroli jakości
19 listopada 2010
Pierwszy wysłany (Oszacować)
22 listopada 2010
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
10 marca 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
30 stycznia 2017
Ostatnia weryfikacja
1 stycznia 2017
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 0000-204
- CTRI/2013/02/003429 (Identyfikator rejestru: CTRI)
Plan dla danych uczestnika indywidualnego (IPD)
Badanie danych/dokumentów
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .