Effect of Statins on Lipid Levels Following the First Acute Coronary Event (MK-0000-204) (REMAINS)
30 januari 2017 bijgewerkt door: 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).
Studie Overzicht
Toestand
Voltooid
Studietype
Observationeel
Inschrijving (Werkelijk)
635
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
35 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Participants
Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Total Cholesterol (TC) Levels at First Acute Coronary Event
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline and at Week 12
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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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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 But Did Not Achieve Target Lipid Levels for HDL-C and LDL-C After 12 Weeks of Treatment With Statins
Tijdsspanne: 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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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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 augustus 2010
Primaire voltooiing (Werkelijk)
1 december 2012
Studie voltooiing (Werkelijk)
1 december 2012
Studieregistratiedata
Eerst ingediend
13 augustus 2010
Eerst ingediend dat voldeed aan de QC-criteria
19 november 2010
Eerst geplaatst (Schatting)
22 november 2010
Updates van studierecords
Laatste update geplaatst (Werkelijk)
10 maart 2017
Laatste update ingediend die voldeed aan QC-criteria
30 januari 2017
Laatst geverifieerd
1 januari 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 0000-204
- CTRI/2013/02/003429 (Register-ID: CTRI)
Plan Individuele Deelnemersgegevens (IPD)
Bestudeer gegevens/documenten
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