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

Primary Purpose

Coronary Heart Disease

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Clopidogrel 75mg

Clopidogrel 150mg

Aspirin 100mg

Cilostazol 100mg

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring PCI, platelet function monitoring, Thrombelastography, clopidogrel, cilostazol, in-stent thrombosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fuwai Cardiovascular Hospital
Fuwai Cardiovascular Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Clopidogrel + Aspirit

Clopidogrel + Aspirin

Clopidogrel + Aspirin + Cilostazol

Arm Description

A Standard antiplatelet therapy control group： Clopidogrel 75mg Qd + Aspirin 100mg Qd

B Double-dosage Clopidogrel group： Clopidogrel 150mg Qd + Aspirin 100mg Qd

C triple antiplatelet therapy group： Cilostazol 100mg Bid + Aspirin 100mg Qd + Clopidogrel 75mg Qd

Outcomes

Primary Outcome Measures

Major adverse cardiac and cerebrovascular events

MACCE, including cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular events

Secondary Outcome Measures

Secondary endpoint

Occurrence of stent thrombosis

bleeding

Major bleeding and minor bleeding

quality of life of patient

to evaluate with Seattle Angina Scale

Full Information

NCT ID

NCT01779401

First Posted

January 15, 2013

Last Updated

July 18, 2017

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborators

Beijing Municipal Health Bureau, Haemonetics Corporation, Zhejiang Otsuka Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01779401

Brief Title

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

Acronym

CREATIVE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborators

Beijing Municipal Health Bureau, Haemonetics Corporation, Zhejiang Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Heart Disease

Keywords

PCI, platelet function monitoring, Thrombelastography, clopidogrel, cilostazol, in-stent thrombosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1078 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clopidogrel + Aspirit

Arm Type

Active Comparator

Arm Description

A Standard antiplatelet therapy control group： Clopidogrel 75mg Qd + Aspirin 100mg Qd

Arm Title

Clopidogrel + Aspirin

Arm Type

Active Comparator

Arm Description

B Double-dosage Clopidogrel group： Clopidogrel 150mg Qd + Aspirin 100mg Qd

Arm Title

Clopidogrel + Aspirin + Cilostazol

Arm Type

Active Comparator

Arm Description

C triple antiplatelet therapy group： Cilostazol 100mg Bid + Aspirin 100mg Qd + Clopidogrel 75mg Qd

Intervention Type

Drug

Intervention Name(s)

Clopidogrel 75mg

Intervention Type

Drug

Intervention Name(s)

Clopidogrel 150mg

Intervention Type

Drug

Intervention Name(s)

Aspirin 100mg

Intervention Type

Drug

Intervention Name(s)

Cilostazol 100mg

Primary Outcome Measure Information:

Title

Major adverse cardiac and cerebrovascular events

Description

MACCE, including cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular events

Time Frame

within 1.5years of patient enrolled

Secondary Outcome Measure Information:

Title

Secondary endpoint

Description

Occurrence of stent thrombosis

Time Frame

within 1.5 years of patients enrolled

Title

bleeding

Description

Major bleeding and minor bleeding

Time Frame

within 1.5 years of patients' enrolled

Title

quality of life of patient

Description

to evaluate with Seattle Angina Scale

Time Frame

within 1.5 years of patients' enrolled

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuejin Yang, PHD

Organizational Affiliation

Fuwai Hospital, CAMS & PUMC

Official's Role

Study Chair

Facility Information:

Facility Name

Fuwai Cardiovascular Hospital

City

Beijing

ZIP/Postal Code

100037

Country

China

Facility Name

Fuwai Cardiovascular Hospital

City

Beijing

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

29420189

Citation

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.

Results Reference

derived

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

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