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Trial record 49 of 282 for:    Best Disease

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

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ClinicalTrials.gov Identifier: NCT01779401
Recruitment Status : Completed
First Posted : January 30, 2013
Last Update Posted : July 19, 2017
Sponsor:
Collaborators:
Beijing Municipal Health Bureau
Haemonetics Corporation
Zhejiang Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Yi-Da Tang, Chinese Academy of Medical Sciences, Fuwai Hospital

Tracking Information
First Submitted Date  ICMJE January 15, 2013
First Posted Date  ICMJE January 30, 2013
Last Update Posted Date July 19, 2017
Study Start Date  ICMJE September 2012
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01779401 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients
Official Title  ICMJE Investigator Initiated Prospective Study to Investigate the Best Anti-platelet Treatment in High Thrombotic Risk PCI Patients.
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Heart Disease
Intervention  ICMJE
  • Drug: Clopidogrel 75mg
  • Drug: Clopidogrel 150mg
  • Drug: Aspirin 100mg
  • Drug: Cilostazol 100mg
Study Arms  ICMJE
  • Active Comparator: Clopidogrel + Aspirit
    A Standard antiplatelet therapy control group: Clopidogrel 75mg Qd + Aspirin 100mg Qd
    Interventions:
    • Drug: Clopidogrel 75mg
    • Drug: Aspirin 100mg
  • Active Comparator: Clopidogrel + Aspirin
    B Double-dosage Clopidogrel group: Clopidogrel 150mg Qd + Aspirin 100mg Qd
    Interventions:
    • Drug: Clopidogrel 150mg
    • Drug: Aspirin 100mg
  • Active Comparator: Clopidogrel + Aspirin + Cilostazol
    C triple antiplatelet therapy group: Cilostazol 100mg Bid + Aspirin 100mg Qd + Clopidogrel 75mg Qd
    Interventions:
    • Drug: Clopidogrel 75mg
    • Drug: Aspirin 100mg
    • Drug: Cilostazol 100mg
Publications * Tang YD, Wang W, Yang M, Zhang K, Chen J, Qiao S, Yan H, Wu Y, Huang X, Xu B, Gao R, Yang Y; CREATIVE Investigators. Randomized Comparisons of Double-Dose Clopidogrel or Adjunctive Cilostazol Versus Standard Dual Antiplatelet in Patients With High Posttreatment Platelet Reactivity: Results of the CREATIVE Trial. Circulation. 2018 May 22;137(21):2231-2245. doi: 10.1161/CIRCULATIONAHA.117.030190. Epub 2018 Feb 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2017)
1078
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2013)
1050
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01779401
Other Study ID Numbers  ICMJE 2011-4003-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yi-Da Tang, Chinese Academy of Medical Sciences, Fuwai Hospital
Study Sponsor  ICMJE Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborators  ICMJE
  • Beijing Municipal Health Bureau
  • Haemonetics Corporation
  • Zhejiang Otsuka Pharmaceutical Co., Ltd.
Investigators  ICMJE
Study Chair: Yuejin Yang, PHD Fuwai Hospital, CAMS & PUMC
PRS Account Chinese Academy of Medical Sciences, Fuwai Hospital
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP