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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Cardiovascular Institute & Fuwai Hospital
Sponsor:
Collaborators:
Beijing Municipal Health Bureau
Haemonetics Corporation
Zhejiang Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Yi-Da Tang, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier:
NCT01779401
First received: January 15, 2013
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Coronary Heart Disease
Drug: Clopidogrel 75mg
Drug: Clopidogrel 150mg
Drug: Aspirin 100mg
Drug: Cilostazol 100mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigator Initiated Prospective Study to Investigate the Best Anti-platelet Treatment in High Thrombotic Risk PCI Patients.

Resource links provided by NLM:


Further study details as provided by Cardiovascular Institute & Fuwai Hospital:

Primary Outcome Measures:
  • Major adverse cardiac and cerebrovascular events [ Time Frame: within 1.5years of patient enrolled ] [ Designated as safety issue: Yes ]
    MACCE, including cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular events


Secondary Outcome Measures:
  • Secondary endpoint [ Time Frame: within 1.5 years of patients enrolled ] [ Designated as safety issue: Yes ]
    Occurrence of stent thrombosis

  • bleeding [ Time Frame: within 1.5 years of patients' enrolled ] [ Designated as safety issue: Yes ]
    Major bleeding and minor bleeding

  • quality of life of patient [ Time Frame: within 1.5 years of patients' enrolled ] [ Designated as safety issue: No ]
    to evaluate with Seattle Angina Scale


Estimated Enrollment: 1050
Study Start Date: September 2012
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clopidogrel + Aspirit
A Standard antiplatelet therapy control group: Clopidogrel 75mg Qd + Aspirin 100mg Qd
Drug: Clopidogrel 75mg Drug: Aspirin 100mg
Active Comparator: Clopidogrel + Aspirin
B Double-dosage Clopidogrel group: Clopidogrel 150mg Qd + Aspirin 100mg Qd
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
Drug: Clopidogrel 75mg Drug: Aspirin 100mg Drug: Cilostazol 100mg

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779401

Contacts
Contact: Yida Tang, PHD 86 113701018290 tangyida@gmail.com

Locations
China
Fuwai Cardiovascular Hospital Recruiting
Beijing, China, 100037
Contact: Min Yang, Master    86 18610433489    yangminfw@gmail.com   
Principal Investigator: Yida Tang, MDs         
Sponsors and Collaborators
Cardiovascular Institute & Fuwai Hospital
Beijing Municipal Health Bureau
Haemonetics Corporation
Zhejiang Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Chair: Yuejin Yang, PHD Fuwai Hospital, CAMS & PUMC
  More Information

No publications provided

Responsible Party: Yi-Da Tang, Professor, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier: NCT01779401     History of Changes
Other Study ID Numbers: 2011-4003-03
Study First Received: January 15, 2013
Last Updated: January 28, 2013
Health Authority: China: Ethics Committee

Keywords provided by Cardiovascular Institute & Fuwai Hospital:
PCI
platelet function monitoring
Thrombelastography
clopidogrel
cilostazol
in-stent thrombosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Cilostazol
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014