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

Coronary Heart Disease Clinical Trial

— CREATIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779401
• Other study ID #: 2011-4003-03
• Status: Completed
• Phase: N/A
• First received: January 15, 2013
• Last updated: July 18, 2017
• Start date: September 2012
• Est. completion date: September 2016

Study information

• Verified date: July 2017
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1078
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18 - 75, male or non-pregnant female;

2. Stable or unstable angina with evidence of myocardial ischemia, or patient with myocardial infarction;

3. Coronary angiography reveals stenosis lesions;

4. 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);

5. Is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form.

Exclusion Criteria:

1. Those who have participated in other drug or therapy equipment clinical trials but did not reach the main study endpoint time limit;

2. Symptoms of severe heart failure (NYHA Class III and above) or left ventricular ejection fraction < 40% (ultrasound or left ventricle ngiography);

3. Pregnant or lactating women;

4. severely impaired renal function before surgery: serum creatinine > 2.0mg/dl;

5. Impaired liver function before surgery: Serum GPT > 120U/L;

6. 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;

7. Patients who are unable to withstand dual antiplatelet therapy due to allergy to Aspirin, Clopidogrel or ticlopidine, heparin, contrast agent, paclitaxel and metals;

8. Leucocyte < 3.5 x 109; and/or platelet < 100,000/mm3 or > 750,000/mm3;

9. Patient's life expectancy is less than 12 months;

10. Patients who plan to undergo coronary artery bypass grafting or other surgery within 1 year;

11. Those waiting for heart transplant;

12. Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• Clopidogrel 75mg

• Clopidogrel 150mg

• Aspirin 100mg

• Cilostazol 100mg

Locations

Country	Name	City	State
China	Fuwai Cardiovascular Hospital	Beijing
China	Fuwai Cardiovascular Hospital	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital	Beijing Municipal Health Bureau, Haemonetics Corporation, Zhejiang Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac and cerebrovascular events	MACCE, including cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular events	within 1.5years of patient enrolled
Secondary	Secondary endpoint	Occurrence of stent thrombosis	within 1.5 years of patients enrolled
Secondary	bleeding	Major bleeding and minor bleeding	within 1.5 years of patients' enrolled
Secondary	quality of life of patient	to evaluate with Seattle Angina Scale	within 1.5 years of patients' enrolled