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

NCT ID: NCT01962428

Last Updated: 2016-11-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Non ST Segment Elevation Acute Coronary Syndrome

Keywords

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ticagrelor loading dose non-ST-segment elevation acute coronary syndromes percutaneous coronary intervention the antiplatelet effects bleeding events major adverse cardiac events

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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high loading dose of ticagrelor

Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.

Group Type EXPERIMENTAL

ticagrelor

Intervention Type DRUG

Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.

conventional loading dose of ticagrelor

Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.

Group Type ACTIVE_COMPARATOR

ticagrelor

Intervention Type DRUG

Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.

Interventions

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ticagrelor

Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.

Intervention Type DRUG

Other Intervention Names

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Brilinta

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Chinese Armed Police Forces

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huiliang Liu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology of General Hospital of Chinese People's Armed Police Forces

Locations

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General Hospital of Chinese People's Armed Police Forces

Beijing, Beijing Municipality, China

Site Status

General Hospital of Chinese People's Armed Police Forces

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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ISSBRIL0214

Identifier Type: -

Identifier Source: org_study_id