Effect of Statins on Lipid Levels Following the First Acute Coronary Event (MK-0000-204) (REMAINS)
30 gennaio 2017 aggiornato da: 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).
Panoramica dello studio
Stato
Completato
Tipo di studio
Osservativo
Iscrizione (Effettivo)
635
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
35 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Participants
Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Total Cholesterol (TC) Levels at First Acute Coronary Event
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
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Week 12
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2010
Completamento primario (Effettivo)
1 dicembre 2012
Completamento dello studio (Effettivo)
1 dicembre 2012
Date di iscrizione allo studio
Primo inviato
13 agosto 2010
Primo inviato che soddisfa i criteri di controllo qualità
19 novembre 2010
Primo Inserito (Stima)
22 novembre 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 marzo 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 gennaio 2017
Ultimo verificato
1 gennaio 2017
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 0000-204
- CTRI/2013/02/003429 (Identificatore di registro: CTRI)
Piano per i dati dei singoli partecipanti (IPD)
Dati/documenti di studio
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .