Efficacy and Safety Study of Ticagrelor

Phase 3

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Clopidogrel; Drug: Ticagrelor

• Registration Number: NCT01812330
• Lead Sponsor: General Hospital of Chinese Armed Police Forces

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

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-03-14
• Study First Submitted QC: 2013-03-14
• Study First Posted: 2013-03-18
• Status Verified: 2015-03
• Last Update Submitted: 2015-06-23
• Last Update Posted: 2015-06-24
• Primary Completion: 2015-12
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 2	Clopidogrel	Group 2 will be administered with Clopidogrel 150mg daily until the end of trial
group 1	Clopidogrel	Group 1 will be administered with Clopidogrel 75mg daily until the end of the trial
group 3	Ticagrelor	Group 3 will be administered with Ticagrelor 90mg twice daily until the end of the trial

Primary Outcome Measures

Name	Time	Method
PRI	post operative 1 month	Platelet funtion were tested by flowcytometric vasodilator-stimulated phosphoprotein(VASP) analysis.And a platelet reactivity index (PRI) was calculated.

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiac events(MACEs)	follow-up for 1 month	cardiovascular death,angiographically confirmed stent thrombosis, recurrent acute coronary syndrome defined by the American College of Cardiology/American Heart Association guidelines,and recurrent revascularization by either coronary angioplasty or bypass surgery
major and minor bleeding	follow-up for 1 month	Major bleeding was defined as intracranial bleeding or clinically-overt bleeding associated with a decrease in hemoglobin of 50 g/L, according to the Thrombolysis inMyocardial Infarction (TIMI) criteria .Minor bleeding was also defined according to TIMI criteria .

Trial Locations

Locations (1)

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