Low-dose Ticagrelor in Chinese ACS Patients Undergoing PCI
Comparative Effectiveness and Safety Analysis of Low-dose and Standard-dose Ticagrelor in Chinese Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
Dual Antiplatelet Therapy (DAPT) with aspirin and P2Y12 receptor inhibitor remains a cornerstone in the secondary prevention of coronary artery disease (CAD). Clopidogrel is one of the most commonly used antithrombotic agent that inhibits the platelet P2Y(12) adenosine diphosphate (ADP) receptor.
Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients. The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was significantly stronger than that in the clopidogrel group. One-quarter standard-dose ticagrelor provided greater degree of platelet inhibition than standard dose clopidogrel in Chinese patients with stable CAD. But the effectiveness and safety of low-dose ticagrelor remain yet not very clearly in Chinese patients with acute coronary syndrome undergoing percutaneous coronary intervention.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Beijing
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Beijing, Beijing, Kina, 100001
- Rekruttering
- Thromboela-Stogram
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Kontakt:
- Liu Yang, MM
- Telefonnummer: 86-010-801231171
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- After half-dose ticagrelor (loading dose 90mg, and then 45mg bidpo.) treatment for 3 days, the platelet aggregation is effectively inhibited by light transmission aggregometry method and thromboela-stogram.
- planned to undergo PCI recently
- planned to DAPT for 1 year after PCI
Exclusion Criteria:
- taken adenosine diphosphate (ADP) receptor antagonists within 2 weeks
- Platelet count <100g/L;
- A history of bleeding tendency;
- Aspirin, ticagrelor or clopidogrel allergies;
- Severe liver injury.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: half-dose ticagrelor
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To observe the effectiveness and safety of ticagrelor 45mg bidpo. in Chinese ACS patients undergoing PCI.
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Aktiv komparator: standard-dose ticagrelor
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To observe the effectiveness and safety of ticagrelor 90mg bidpo. in Chinese ACS patients undergoing PCI.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
thromboela-stogram
Tidsramme: up to 6 months
|
inhibition of platelet aggregation (ADP) ; MA (ADP)
|
up to 6 months
|
|
thromboela-stogram
Tidsramme: up to 1 year
|
inhibition of platelet aggregation; MA
|
up to 1 year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
MACE
Tidsramme: up to 1 year
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cardiovascular death, non-fatal myocardial infarction and stroke
|
up to 1 year
|
|
Side effects including bleeding and dyspnea
Tidsramme: up to 1 year
|
up to 1 year
|
|
|
The rate of treatment interruption due to ticagrelor intolerance.
Tidsramme: up to 1 year
|
up to 1 year
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Yue Li, PhD, Cardiovascular Department, the First Affiliated Hospital of Harbin Medical University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Myokardieiskæmi
- Hjertesygdomme
- Hjerte-kar-sygdomme
- Karsygdomme
- Sygdom
- Syndrom
- Akut koronarsyndrom
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Blodpladeaggregationshæmmere
- Purinerge P2Y-receptorantagonister
- Purinerge P2-receptorantagonister
- Purinerge antagonister
- Purinerge midler
- Ticagrelor
Andre undersøgelses-id-numre
- ACS-3
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