Clinical trial NCT01812330: Efficacy and Safety Study of Ticagrelor
Official title: The Effect of Ticagrelor on Acute Coronary Syndrome Patients With Clopidogrel Resistance Undergoing Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Keywords: ACS
CR
PCI
Platelet funtion
Ticagrelor
Lead sponsor: General Hospital of Chinese Armed Police Forces
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 180
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: The purpose of this study is to compare the efficacy and safety of ticagrelor with clopidogrel

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: PRI
timeFrame: post operative 1 month
Secondary outcomes:
measure: Major adverse cardiac events(MACEs)
timeFrame: follow-up for 1 month
measure: major and minor bleeding
timeFrame: follow-up for 1 month
Other outcomes:
Locations:
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:
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