NCT Number: NCT01779401
Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients
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.
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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Fuwai Cardiovascular Hospital, Beijing, China
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- Those who have participated in other drug or therapy equipment clinical trials but did not reach the main study endpoint time limit;
- Symptoms of severe heart failure (NYHA Class III and above) or left ventricular ejection fraction < 40% (ultrasound or left ventricle ngiography);
- Pregnant or lactating women;
- severely impaired renal function before surgery: serum creatinine > 2.0mg/dl;
- Impaired liver function before surgery: Serum GPT > 120U/L;
- Bleeding tendency, history of active peptic ulcer, history of cerebral hemorrhage or cavum subarachnoidale bleeding, patients with antiplatelet agent and anticoagulant treatment contraindications and hence are unable to undergo anticoagulant therapy;
- Patients who are unable to withstand dual antiplatelet therapy due to allergy to Aspirin, Clopidogrel or ticlopidine, heparin, contrast agent, paclitaxel and metals;
- Leucocyte < 3.5 x 109; and/or platelet < 100,000/mm3 or > 750,000/mm3;
- Patient's life expectancy is less than 12 months;
- Patients who plan to undergo coronary artery bypass grafting or other surgery within 1 year;
- Those waiting for heart transplant;
- Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.
Treatment and study plan
Clopidogrel 150mg
DrugAspirin 100mg
DrugCilostazol 100mg
DrugPrimary outcomes
-
Major adverse cardiac and cerebrovascular events
Time frame: within 1.5years of patient enrolled
MACCE, including cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular events
Secondary outcomes
-
Secondary endpoint
Time frame: within 1.5 years of patients enrolled
Occurrence of stent thrombosis
-
bleeding
Time frame: within 1.5 years of patients' enrolled
Major bleeding and minor bleeding
-
quality of life of patient
Time frame: within 1.5 years of patients' enrolled
to evaluate with Seattle Angina Scale
Sponsors and collaborators
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Other
Collaborators
- Beijing Municipal Health Bureau
- Haemonetics Corporation
- Zhejiang Otsuka Pharmaceutical Co., Ltd.
Registry information
Official study title
Investigator Initiated Prospective Study to Investigate the Best Anti-platelet Treatment in High Thrombotic Risk PCI Patients.
Acronym: CREATIVE
Important dates
- Study start
- 2012
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Jan 30, 2013
- Registry last updated
- Jul 19, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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