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

Information source: Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Heart Disease

Intervention: Clopidogrel 75mg (Drug); Clopidogrel 150mg (Drug); Aspirin 100mg (Drug); Cilostazol 100mg (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Cardiovascular Institute & Fuwai Hospital

Official(s) and/or principal investigator(s):
Yuejin Yang, PHD, Study Chair, Affiliation: Fuwai Hospital, CAMS & PUMC

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Major adverse cardiac and cerebrovascular events

Secondary outcome:

Secondary endpoint

bleeding

quality of life of patient

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Fuwai Cardiovascular Hospital, Beijing 100037, China

Fuwai Cardiovascular Hospital, Beijing, China

Additional Information

Starting date: September 2012
Last updated: August 13, 2015

Page last updated: August 23, 2015

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