Clinical trial NCT01962428: Different LD of Ticagrelor for Antiplatelet Effect in Patients With Non-ST-segment Elevation ACS Undergoing PCI
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non ST Segment Elevation Acute Coronary Syndrome
Keywords: ticagrelor
loading dose
non-ST-segment elevation acute coronary syndromes
percutaneous coronary intervention
the antiplatelet effects
bleeding events
major adverse cardiac events
Lead sponsor: General Hospital of Chinese Armed Police Forces
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Platelet Reactivity Index(PRI) Measured by VASP-P
timeFrame: 2 hours after the loading dose of ticagrelor
Secondary outcomes:
measure: Platelet Reactivity Index (PRI) Measured by VASP-P
timeFrame: 0.5hour,1hour,8hours,24hours after the loading dose of ticagrelor
measure: Bleeding Events
timeFrame: follow-up for 28 days after the loading dose of ticagrelor
Other outcomes:
Locations:
city: Beijing
country: China
facility: General Hospital of Chinese People's Armed Police Forces
state: Beijing
city: Beijing
country: China
facility: General Hospital of Chinese People's Armed Police Forces
Study officials:
affiliation: Department of Cardiology of General Hospital of Chinese People's Armed Police Forces
name: Huiliang Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: