Different LD of Ticagrelor for Antiplatelet Effect in Patients With Non-ST-segment Elevation ACS Undergoing PCI
It is designed to test the hypothesis that high loading dose(360mg) ticagrelor versus conventional loading dose(180mg) will result in a higher inhibition of platelet aggregation(IPA) without increasing the bleeding events.
Non ST Segment Elevation Acute Coronary Syndrome
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Trial of Different Loading Dose of Ticagrelor for Antiplatelet Effect in Patients With Non -ST-segment Elevation ACS Undergoing Percutaneous Coronary Intervention|
- platelet reactivity index(PRI) measured by VASP-P [ Time Frame: 2 hours after the loading dose of ticagrelor ] [ Designated as safety issue: Yes ]Vasodilator-stimulated phosphoprotein(VASP) phosphorylation, a measure of P2Y12 receptor reactivity, was determined by flow cytometry with the use of the Platelet VASP-FCM Kit (Stago, France)and recorded as the platelet reactivity index (PRI).
- platelet reactivity index (PRI) measured by VASP-P [ Time Frame: 0.5hour,1hour,4hours,8hours,24hours after the loading dose of ticagrelor ] [ Designated as safety issue: Yes ]
- bleeding events [ Time Frame: follow-up for 1 month ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: high loading dose of ticagrelor
Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
Other Name: Brilinta
Active Comparator: conventional loading dose of ticagrelor
Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
Other Name: Brilinta
After providing written informed consent, all patients will be randomized to receive ticagrelor 360mg or 180mg loading dose(LD),then 90mg bid maintenance dose starting 12 hours after LD.PCI will performed in 12h-24h after they are given the loading dose.All patients should receive acetylsalicylic acid (ASA) 75 to 100 mg daily unless intolerant.IPA at 0, 0.5, 1, 2, 4, 8, 24h after the loading dose of ticagrelor will be measured. CK-MB, troponin I, myoglobin, CRP will be detected at 0h, before PCI, 8h after PCI, 24h after PCI. ECG will be conducted at 0h, 8h and 24h after PCI. Patients returned 1 month for follow-up visits, documented any adverse events.
|Contact: Huiliang Liu, Doctoremail@example.com|
|Contact: Yujie Wei, Doctor||86-10-57976707|
|General Hospital of Chinese People's Armed Police Forces||Not yet recruiting|
|Beijing, Beijing, China, 100039|
|Contact: Huiliang Liu, Doctor 86-10-57976531 firstname.lastname@example.org|
|Contact: Yujie Wei, Doctor 86-10-57976707|
|Principal Investigator: Meihong Cui, Master|
|Principal Investigator:||Huiliang Liu, Doctor||Department of Cardiology of General Hospital of Chinese People's Armed Police Forces|