Effect of Evolocumab Added to Moderate-Intensity Statin Therapy on LDL-C Lowering and Cardiovascular Adverse Events in Patients With Acute Coronary Syndrome (EMSIACS)
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Forventet)
Tilmelding
Fase
Fase
- Fase 4
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Jing Gao, PHD
- Telefonnummer: +86-13820156072
- E-mail: gaojing2088@163.com
Studiesteder
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-
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Tianjin, Kina, 300222
- Rekruttering
- Tianjin Chest Hospital,
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Kontakt:
- JING GAO, PH.D
- Telefonnummer: 13820156072
- E-mail: gaojing2088@163.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Recent hospitalization for acute coronary syndrome: Complies with the diagnostic criteria for acute coronary syndrome (non-ST-segment elevation myocardial infarction, acute ST-segment elevation myocardial infarction, and unstable angina within 72 hours of onset)
LDL-C level (meet one of the following conditions):
- Prior to the study, patients who received intensive statins for more than 4 weeks (the same dose of statin therapy has been sustained for the past four weeks) with LDL-C levels ≥70 mg/dL (≥1.8 mmol/L) or non-HDL-C ≥100 mg /dL (≥2.6mmol/L) are included in the study;
- Prior to the study, patients who received moderate-intensity statin therapy for more than 4 weeks (the same dose of statin therapy has been sustained for the past four weeks) with LDL-C levels ≥90 mg/dL (≥2.3 mmol/L) or non-HDL-C≥ 120mg/dL (≥3.1mmol/L) are included in the study;
- Prior to the study, patients who do not receive statin therapy or who do not continue to receive statin with LDL-C ≥ 125 mg/dL (≥ 3.2 mmol/L) or non-HDL-C ≥ 155 mg/dL (≥ 4.0 mmol/L).
- Being able to understand research requirements and sign informed consent
Exclusion Criteria:
- Unstable clinical status (hemodynamics or ECG instability)
- Uncontrolled arrhythmia, defined as recurrent or symptomatic ventricular tachycardia and atrial fibrillation with rapid ventricular reaction that the drug cannot control within three months prior to screening
- Severe renal insufficiency, defined as estimated glomerular filtration rate<30ml/min/1.73m2
- Active liver disease or liver dysfunction, whether it is on the patient's medical record or defined as an increase in alanine aminotransferase or aspartate aminotransferase more than 3 times above the upper limit of normal
- Records on statin or rosuvastatin (any dose) intolerance or other statin intolerance
- Known allergies to contrast agents, heparin, aspirin, ticagrelor or clopidogrel
- Known allergies to the supplements required for the use of the drug
- Patients who have been treated with evolocumab or other PCSK9 inhibitors
- Received cholesterol ester transfer protein inhibitors treatment 12 months prior to screening
- Received systemic steroid or cyclosporine treatment in the past 3 months
- Known infections, hemorrhages, metabolic or endocrine disorders as determined by the researchers
- Patients who have been included in other studies
- Patients with active malignant tumor in need of treatment
- Women with fertility (age <50 years, menstruation in the past 12 months), did not receive tubal ligation, oophorectomy or hysterectomy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
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Eksperimentel: the evolocumab plus statin therapy
Patients with ACS are treated with atorvastatin (20mg) daily and evolocumab (140 mg) every two weeks throughout the study period
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Patienterne blev tilfældigt tildelt forholdet 1:1 ved hjælp af et computergenereret tilfældigt tal og opdelt i to behandlingsgrupper: statin alene-behandlingen og evolocumab plus statinbehandling.
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Ingen indgriben: the statin alone therapy
Patients with ACS are treated with atorvastatin (20mg) daily throughout the study period.
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percent change in LDL-C
Tidsramme: 4 weeks
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4 weeks
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Major cardiovascular adverse events
Tidsramme: 4 weeks and 1 year
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Coronary heart disease death,nonfatal myocardial infarction,hospitalization for unstable angina,unplanned coronary revascularization, and stroke
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4 weeks and 1 year
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Andre resultatmål
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The mean percentage change from baseline in LDL-C levels
Tidsramme: within 1 year
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within 1 year
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The proportion of patients with LDL-C <70 mg/dL during treatment
Tidsramme: week 4 and week 12
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week 4 and week 12
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the quality of life of patients
Tidsramme: week 12 and week 48
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using EQ-5D-3L questionnaire score to assess the quality of life
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week 12 and week 48
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The effect of evolocumab on platelet function based on the area under curve
Tidsramme: from baseline to 72 hours and baseline to week 4
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using Col/ADP test to evaluate platelet function
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from baseline to 72 hours and baseline to week 4
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the effect of evolocumab on the percentage change of inflammatory markers (high-sensitivity C-reactive protein)
Tidsramme: from baseline to week 48
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from baseline to week 48
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Studiestart
Primær færdiggørelse (Forventet)
Primær færdiggørelse
Studieafslutning (Forventet)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- EMSIACS
Plan for individuelle deltagerdata (IPD)
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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