- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01382277
Rosuvastatin Effect on Reducing Coronary Atherosclerosis Plaques Volume (REDUCT)
23. juni 2011 opdateret af: Peking University First Hospital
Rosuvastatin Effect on Reducing Coronary Atherosclerosis Plaques Volume Evaluated by Multi-slice Spiral CT in Patients With Stable Coronary Heart Disease and Hyperlipidemia
This multicentre, open-label, single-arm Study is to evaluate the effect of Rosuvastatin 20 mg 76 weeks on coronary atherosclerosis plaque versus baseline in Chinese coronary heart disease (CHD) patients with hyperlipidemia by measuring the plaque volume using a 64 slice spiral CT.
Effect on blood lipids, hsCRP and Carotid intima-media thickness (CIMT) is also evaluated.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
600
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Beijing, Kina, 100034
- Rekruttering
- Division of Cardiology, Peking University First Hospital
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Kontakt:
- Jie Jiang, MD
- Telefonnummer: 86-10-66551383
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Beijing
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Beijing, Beijing, Kina, 100034
- Rekruttering
- Peking University First Hospital
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Kontakt:
- Yanjun Gong, MD
- Telefonnummer: 86-10-83572299
- E-mail: gongyanjun111@163.com
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Written informed consent
- Men or women, aged 18 -75
Diagnosed with coronary heart disease (CHD) stable angina for more than 1 month and meet the following any one:
- History of myocardial infarction.
- CHD confirmed by coronary angiography.
- Excercise ECG positive for CHD or perfusion defect
- One or more main branch of coronary artery stenosis ≥ 50% confirmed by CT scanning.
- Hyperlipidemia (lipid-lowering treatment naïve: LDL-C ≥130mg/dl, or having received lipid-lowering treatment: LDL-C ≥100mg/dl)
The 64 slice CT shows at least one significant coronary artery stenosis ≥20% with the narrowest ≤60% and meeting the following criteria:
- Diameter of coronary artery lesion ≥2mm, length ≥5mm; distance between multiple lesions >1cm
- Plaque density <100HU, no calcification
- Vascular stenosis (20~60%) caused by plaques
- Plaque thickness >1mm
- Plaque not in the coronary artery with previous PCI treatment.
Exclusion Criteria:
- Acute myocardial infarction within 6 months
- PCI or CABG therapy within 6 months
- Anticipated PCI or CABG therapy in the following 3 months.
- Tropnin I/Tropnin T higher than ULN
- Cardiac failure NYHA III or above
- Coronary artery left main stenosis >50%
- Emergency coronary angiography(CAG) is needed
- Serious arrhythmia or tachycardia
- Secondary hyperlipidemia
- Familial hypercholestrolemia
- Uncontrolled severe hypertension (≥200/110 mmHg)
- Uncontrolled diabetes (HbA1c ≥9.5%)
- Triglyceride ≥500 mg/dL (5.65 mmol/L)
- Active hepatic disease or hepatic function impairment, ALT≥3ULN
- Serum creatinine >177 µmol/L (2.0 mg/dL)
- Myalgia or blood CK ≥5ULN
- WBC < 4×10e9/L,or PLT < 100*10e9/L。
- Participation in the the course of plan and/or procedure of this study
- Previous participation in the study treatment
- Participation in other clinical studies in the past 3 months
- Pregnant or breast-feeding women, women with child-bearing potential who did not use drugs or devices for contraception, or women with positive urine pregnancy test (human chorionic gonadotropin [HCG])
- History of malignant tumors (exception: recovered more than 10 years or only basal cell carcinoma or squamous cell carcinoma); females with a history of cervical atypical hyperplasia (exception: 3 consecutive cervical smear tests normal prior to enrolment)
- History of alcohol and/or drug abuse in recent 5 years
- Any serious or unstable physical or psychological conditions, in the opinion of the investigator, would compromise the safety of the patient or the participation in this study
- Use of concomitant medications prohibited in this study ( Erythromycin, clarithromycin, erythromycin ethylsuccinate, sulfaphenazole; Fluconazole, ketoconazole, itraconazole; Niacin / nicotinic acid(including vitamins/food additives containing niacin / nicotinic acid >50mg), probucol, clofibrate, cholestyramine, colestipol hydrochloride, ezetimibe, fenofibrate, gemfibrozil, atorvastatin(exception: study medication),lovastatin, pravastatin, rosuvastatin (exception: study medication) , Simvastatin, fluvastatin, fish oil (any dose), lipid-lowering supplements and food additives; Cyclosporine; Protease inhibitors)
- Use of periodic hormone replacement treatment(HRT), oral contraceptives(OCTs), long-acting progesterone, or in recent 3 months non-periodic HRT or OCTs
- Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Rosuvastatin 20 mg
Rosuvastatin 20 mg for 76 weeks.
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Rosuvastatin 20 mg per day for 76 weeks
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change from baseline in coronary atherosclerosis plaque volume using a 64 slice spiral CT at 76 weeks
Tidsramme: 76 weeks
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76 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change from baseline in blood lipids at 26 weeks
Tidsramme: 26 weeks
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26 weeks
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Change from baseline in hsCRP at 26 weeks
Tidsramme: 26 weeks
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26 weeks
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Change from baseline in Carotid intima-media thickness at 76 weeks
Tidsramme: 76 weeks
|
76 weeks
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Number of participants with adverse events and abnormal laboratory safety markers.
Tidsramme: 76 weeks
|
76 weeks
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Change from baseline in blood lipids at 52 weeks
Tidsramme: 52 weeks
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52 weeks
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Change from baseline in blood lipids at 76 weeks
Tidsramme: 76 weeks
|
76 weeks
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Change from baseline in hsCRP at 52 weeks
Tidsramme: 52 weeks
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52 weeks
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Change from baseline in hsCRP at 76 weeks
Tidsramme: 76 weeks
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76 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2011
Primær færdiggørelse (Forventet)
1. april 2013
Studieafslutning (Forventet)
1. april 2013
Datoer for studieregistrering
Først indsendt
20. juni 2011
Først indsendt, der opfyldte QC-kriterier
23. juni 2011
Først opslået (Skøn)
27. juni 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. juni 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juni 2011
Sidst verificeret
1. februar 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjertesygdomme
- Hjerte-kar-sygdomme
- Karsygdomme
- Metaboliske sygdomme
- Åreforkalkning
- Arterielle okklusive sygdomme
- Koronar sygdom
- Lipidmetabolismeforstyrrelser
- Dyslipidæmi
- Koronararteriesygdom
- Myokardieiskæmi
- Åreforkalkning
- Hyperlipidæmi
- Hyperlipoproteinæmier
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antimetabolitter
- Antikolesteræmiske midler
- Hypolipidæmiske midler
- Lipidregulerende midler
- Hydroxymethylglutaryl-CoA-reduktasehæmmere
- Rosuvastatin Calcium
Andre undersøgelses-id-numre
- REDUCT
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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