Different LD of Ticagrelor for Antiplatelet Effect in Patients With Non-ST-segment Elevation ACS Undergoing PCI

Phase 4

Completed

• Conditions: Non ST Segment Elevation Acute Coronary Syndrome
• Interventions: Drug: ticagrelor

• Registration Number: NCT01962428
• Lead Sponsor: General Hospital of Chinese Armed Police Forces

Brief Summary

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.

Detailed Description

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 2h-72h 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, 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 and within 24h after PCI. Patients returned 28 days for follow-up visits after the loading dose of ticagrelor, documented any adverse events.

Study Timeline

• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-10-10
• Study First Posted: 2013-10-14
• Study Start: 2014-06
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2016-09-21
• Results First Submitted QC: 2016-09-21
• Last Update Submitted: 2016-09-21
• Results First Posted: 2016-11-09
• Last Update Posted: 2016-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Provision of informed consent prior to any study specific procedures.
• Male or non-pregnant female; aged from 18 to 80 years old.
• Patients with non-ST-segment elevation acute coronary syndromes who were scheduled to undergoing PCI.

Exclusion Criteria

• Any contraindication against the use of ticagrelor.
• On treatment with a P2Y12 receptor antagonist in past 30 days.
• Known allergies to aspirin or ticagrelor.
• On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
• Known blood dyscrasia or bleeding diathesis.
• ST-segment elevation acute myocardial infarction.
• Non-ST segment elevation acute coronary syndrome with high-risk features warranting emergency coronary angiography.
• Left ventricular ejection fraction ≤30%; renal failure with creatinine 3 mg/dl; history of liver disease; an increased risk of bradycardia, and concomitant therapy with drugs interfering with CYP3A4 metabolism.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high loading dose of ticagrelor	ticagrelor	Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
conventional loading dose of ticagrelor	ticagrelor	Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.

Primary Outcome Measures

Name	Time	Method
Platelet Reactivity Index(PRI) Measured by VASP-P	2 hours after the loading dose of ticagrelor	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).

Secondary Outcome Measures

Name	Time	Method
Platelet Reactivity Index (PRI) Measured by VASP-P	0.5hour,1hour,8hours,24hours after the loading dose of ticagrelor
Bleeding Events	follow-up for 28 days after the loading dose of ticagrelor

Trial Locations

Locations (1)

General Hospital of Chinese People's Armed Police Forces; 🇨🇳 Beijing, China