- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03599284
The Efficacy, Safety and Pharmacokinetic of Antiplatelet Therapy for Vicagrel
19. september 2019 opdateret af: Jiangsu vcare pharmaceutical technology co., LTD
The Efficacy, Safety and Pharmacokinetic of Antiplatelet Therapy for Vicagrel in Patients With Coronary Atherosclerotic Heart Disease and Planned Percutaneous Coronary Intervention: a Multi-center, Randomized, Double-blind, Triple-dummy , Parallel-controlled, Dose-exploration Phase II Trial
This is a multi-center, randomized, double-blind, triple-dummy, parallel-controled, dose-exploration phase II trial.
Patients with coronary atherosclerotic heart disease and planned percutaneous coronary intervention (PCI) will be randomized after informed consent, in a 1:1:1:1 ratio to the following treatment groups: Experimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days; Experimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days; Experimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days; Control group : Clopidogrel 300mg loading followed by 75mg/day for 28 days.
The primary purpose of this trial is to evaluate the efficacy, safety of vicagrel antiplatelet therapy and explore dose in patients with coronary atherosclerotic heart disease during and after PCI compared with clopidogrel.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
279
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Beijing, Kina, 100029
- China-Japan Friendship Hospital
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Beijing, Kina, 100032
- Peking Union Medical College Hospital
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Tianjin, Kina, 300121
- Tianjin People's Hospital
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Tianjing, Kina, 300052
- Tianjin Medical University General Hospital
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Anhui
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Bengbu, Anhui, Kina, 233004
- First Affiliated Hospital Bengbu Medical College
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Beijing
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Beijing, Beijing, Kina, 100029
- Beijing Anzhen Hospital, Capital Medical Universily
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Guangdong
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Guangzhou, Guangdong, Kina, 510030
- Guangdong General Hospital
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Guangzhou, Guangdong, Kina, 510080
- First Affiliated Hospital of Zhongshan University
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Hebei
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Shijiazhuang, Hebei, Kina, 050100
- First Hospital of Hebei Medical University
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Hubei
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Wuhan, Hubei, Kina, 430022
- Wuhan Asia Heart Hospital
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Hunan
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Changsha, Hunan, Kina, 410008
- Xiangya Hospital of Central South University
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Changsha, Hunan, Kina, 410004
- Changsha Central Hospital
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Changsha, Hunan, Kina, 410011
- Second Xiangya Hospital of Central South University
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Changsha, Hunan, Kina, 410013
- Third Xiangya Hospital of Central South University
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Jiangsu
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Nanjing, Jiangsu, Kina, 210008
- Affiliated Drum Tower Hospital of Nanjing University Medical School
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Nanjing, Jiangsu, Kina, 210009
- Zhongda Hospital of Southeast University
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Jiangxi
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Nanchang, Jiangxi, Kina, 330006
- Jiangxi Provincial People's Hospital
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Jilin
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Changchun, Jilin, Kina, 130021
- First Hospital of Jilin University
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Jinin
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Changchun, Jinin, Kina, 130041
- Second Hospital of Jilin University
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Liaoning
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Shenyang, Liaoning, Kina, 110015
- the General Hospital of Shenyang Military Region of The Chinese People's Liberation Army(The General Hospital of Shenyang Military)
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Shenyang, Liaoning, Kina, 110015
- The People's Hospital of Liaoning Province
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Shenyang, Liaoning, Kina, 110134
- Shengjing Hospital of China Medical University
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Qinghai
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Xining, Qinghai, Kina, 810007
- Qinghai Provincial People's Hospital
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Shanxi
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Yuncheng, Shanxi, Kina, 044000
- Yuncheng Central Hospital
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Sichuan
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Luzhou, Sichuan, Kina, 646000
- Affiliated Hospital of Southwest Medical University
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310009
- Second Affiliated Hospital of Zhejiang University School of Medicine
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Hangzhou, Zhejiang, Kina, 310020
- Sir Run Run Shaw Hospital
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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:
- Male and female aged 18-75.
- Weight ≥ 50 kg
- Patients with coronary atherosclerotic heart disease diagnosed clinically and planned percutaneous coronary intervention
- Patients with ability and willingness to sign informed consent and adherence to trial protocol.
Exclusion Criteria:
- Hemorrhagic symptoms (such as hematemesis, melena, severe or recurrent epistaxis, hemoptysis, marked hematuria, gastrointestinal bleeding, or intracranial hemorrhage), or suspected vascular malformations (such as aneurysms), or abnormal bleeding history (such as abnormal hemorrhage attributed to tooth extraction), himself or his immediate family with coagulation or bleeding disorders (such as hemophilia);
- Non-ST-segment elevation acute coronary syndrome (<2h emergency PCI), or ST-segment elevation myocardial infarction within 7 days;
- Patients with suspected aortic dissection;
- Patients with negative coronary Computed Tomography angiography(CTA)(coronary CTA depending on investigator);
- Patients with severe disease and life expectancy <1 year;
- Patients with acute peptic ulcer;
- History of hemorrhagic stroke or history of ischemic stroke within 6 months before screening and a definite diagnosis of structural abnormalities in the central nervous system;
- Patients with uncontrolled high blood pressure (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg) after drug treatment during screening;
- One of the following conditions: cardiogenic shock, chronic congestive heart with failure New York Heart Association (NYHA) grade ≥ III grade or left ventricular ejection fraction determined by echocardiography < 35%, hypotension (systolic pressure < 90 mmHg and or diastolic pressure < 60 mmHg), severe arrhythmias (including high-degree atrioventricular block, sick sinus syndrome, persistent ventricular tachycardia), severe pulmonary insufficiency, pulmonary embolism, and hepatic insufficiency (ALT or AST caused by non-cardiac diseases exceeding the upper limit of normal by more than 3 times), severe renal insufficiency (eGFR < 30 ml/min), cirrhosis;
- Patients Received P2Y12 receptor antagonist and Ⅱb/IIIa receptor inhibitor, oral anticoagulant (warfarin, rivaroxaban, dabigatran, etc.) within 14 days before screening;
- Prolonged cardiopulmonary resuscitation (more than 10 minutes) or severe trauma within 2 weeks before screening;
- Patients plan to undergo another surgery within 1 month after participating in this trial,or plan to undergo PCI procedure performed several times during the test (except for the end of the safety follow-up);
- History of severe allergies, non-allergic drug reactions or allergies to 2 or more drugs (including contrast agents), or known allergies to the similar drugs (clopidogrel, ticagrelor) as the study drug or contraindication of aspirin;
- Patients with mental disorders or alcohol dependence;
- Patients being receiving any experimental medicine or experimental medical devices;
- Prothrombin time (PT)> 1.3 times the upper limit of normal or international normalized ratio (INR)> 2.0;
- Platelet count (PLT) < 100×10^9/L or > 600×10^9/L;
- Hemoglobin < 10g/dL;
- Patients who cannot tolerate dual antiplatelet therapy for 28 days;
- Female of reproductive age with positive blood pregnancy test;
- Female with gestational intention or in lactation;
- Other unsuitable conditions considered by investigators.
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Experimental group 1
Experimental group 1: Vicagrel 20mg loading followed by 5mg/day for 28 days
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Experimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days
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Eksperimentel: Experimental group 2
Experimental group 2: Vicagrel 24mg loading followed by 6mg/day for 28 days
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Experimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days
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Eksperimentel: Experimental group 3
Experimental group 3: Vicagrel 30mg loading followed by 7.5mg/day for 28 days
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Experimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days
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Aktiv komparator: Control group
Control group: Clopidogrel 300mg loading followed by 75mg/day for 28 days
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Control group : Clopidogrel 300mg loading followed by 75mg/day for 28 days
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Inhibition of platelet aggregation
Tidsramme: 28 days after treatment
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Inhibition of platelet aggregation will be assessed by Verifynow System
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28 days after treatment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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 (Faktiske)
30. august 2018
Primær færdiggørelse (Faktiske)
11. juni 2019
Studieafslutning (Faktiske)
28. juli 2019
Datoer for studieregistrering
Først indsendt
9. juli 2018
Først indsendt, der opfyldte QC-kriterier
23. juli 2018
Først opslået (Faktiske)
26. juli 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. september 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. september 2019
Sidst verificeret
1. juli 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Myokardieiskæmi
- Hjertesygdomme
- Hjerte-kar-sygdomme
- Karsygdomme
- Åreforkalkning
- Arterielle okklusive sygdomme
- Koronar sygdom
- Koronararteriesygdom
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Blodpladeaggregationshæmmere
- Purinerge P2Y-receptorantagonister
- Purinerge P2-receptorantagonister
- Purinerge antagonister
- Purinerge midler
- Clopidogrel
Andre undersøgelses-id-numre
- VCP1-Ⅱ-01
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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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