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Completed

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Cardiovascular Hospital, Beijing, China

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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 75mg

Drug

Clopidogrel 150mg

Drug

Aspirin 100mg

Drug

Cilostazol 100mg

Drug

Primary outcomes

  1. 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

  1. Secondary endpoint

    Time frame: within 1.5 years of patients enrolled

    Occurrence of stent thrombosis

  2. bleeding

    Time frame: within 1.5 years of patients' enrolled

    Major bleeding and minor bleeding

  3. 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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