Efficacy and Safety Study of Ticagrelor

General Hospital of Chinese Armed Police Forces

Status and phase: Unknown; Phase 3

Conditions: Acute Coronary Syndrome

Treatments: Drug: Clopidogrel; Drug: Ticagrelor

Study type: Interventional

Funder types: Other

Identifiers

NCT01812330

20130118 CR

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of ticagrelor with clopidogrel

Full description

180 elective percutaneous coronary intervention patients with clopidogrel resistance were randomized to three groups, Group 1:received clopidogrel 75mg qd ;Group 2:received clopidogrel 150mg qd ; Group 3:received ticagrelor 90mg bid after PCI.Platelet funtion were tested by flowcytometric vasodilator-stimulated phosphoprotein(VASP) analysis before PCI,and 3days,7days and 1 month after PCI,respectively.The aim of our study is to compare the efficacy and safety of ticagrelor with clopidogrel

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1.Clinical diagnosis of ACS 2.undergoing PCI 3.with clopidogrel resistance

Exclusion criteria

• 1.any contraindication against the use of clopidogrel and ticagrel 2.Contradiction to aspirin and contrast medium 3.Life expectancy less than 1 year 4.Tumor or inflammatory diseases5. fibrinolytic therapy within 24 hours before randomization 6.a need for oral anticoagulation therapy 7. an increased risk of bradycardia 8.concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer 9.a history of asthma.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 3 patient groups

group 1

Experimental group

Description:

Group 1 will be administered with Clopidogrel 75mg daily until the end of the trial

Treatment:

Drug: Clopidogrel

group 2

Experimental group

Description:

Group 2 will be administered with Clopidogrel 150mg daily until the end of trial

Treatment:

Drug: Clopidogrel

group 3

Experimental group

Description:

Group 3 will be administered with Ticagrelor 90mg twice daily until the end of the trial

Treatment:

Drug: Ticagrelor