NCT01779401

Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients

Investigator Initiated Prospective Study to Investigate the Best Anti-platelet Treatment in High Thrombotic Risk PCI Patients.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,078 (actual)
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To identify the high-risk patients who might have in-stent thrombosis after PCI with thromboelastography and to head-to-head compare two intensified antiplatelet therapeutic strategies of double-dosage Clopidogrel and triple antiplatelet therapy with Cilostazol with the standard antiplatelet therapy.

Detailed description

Study population: Age 18 - 75, male or non-pregnant female; stable or unstable angina with evidence of myocardial ischemia, or patient with myocardial infarction; coronary angiography reveals stenosis lesions; discovery of ADP induced platelet inhibition rate \< 50% and MAADP \> 47mm via thromboelastography (indicating low responsiveness to Clopidogrel with high risk for stent thrombosis formation); is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
DRUG	Clopidogrel 75mg
DRUG	Clopidogrel 150mg
DRUG	Aspirin 100mg
DRUG	Cilostazol 100mg

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2013-01-30
• Last updated: 2017-07-19

Locations

2 sites across 1 country: China