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Efficacy and Safety Study of Ticagrelor

The Effect of Ticagrelor on Acute Coronary Syndrome Patients With Clopidogrel Resistance Undergoing Percutaneous Coronary Intervention

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01812330
Enrollment
180
Registered
2013-03-18
Start date
2013-01-31
Completion date
2016-07-31
Last updated
2015-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

ACS, CR, PCI, Platelet funtion, Ticagrelor

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

Interventions

DRUGClopidogrel

After 600mg loading dose, 75mg or 150mg Qd

DRUGTicagrelor

90mg Bid

Sponsors

General Hospital of Chinese Armed Police Forces
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
PRIpost operative 1 monthPlatelet funtion were tested by flowcytometric vasodilator-stimulated phosphoprotein(VASP) analysis.And a platelet reactivity index (PRI) was calculated.

Secondary

MeasureTime frameDescription
Major adverse cardiac events(MACEs)follow-up for 1 monthcardiovascular 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 bleedingfollow-up for 1 monthMajor 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 .

Countries

China

Contacts

Primary Contacthuiliang liu, doctor
lhl518@vip.sina.com86-10-57976531
Backup Contactyujie wei, doctor
86-10-57976707

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026