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

NCT01779401 | Completed DMC

• 1 other identifier: 2011-4003-03
• Study Type: interventional
• Target: 1,078
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Heart Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac and cerebrovascular events

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

  within 1.5years of patient enrolled

Secondary Outcomes (3)

• Secondary endpoint

  within 1.5 years of patients enrolled

• bleeding

  within 1.5 years of patients' enrolled

• quality of life of patient

  within 1.5 years of patients' enrolled

Study Arms (3)

Clopidogrel + Aspirit

ACTIVE COMPARATOR

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

Drug: Clopidogrel 75mg; Drug: Aspirin 100mg

Clopidogrel + Aspirin

ACTIVE COMPARATOR

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

Drug: Clopidogrel 150mg; Drug: Aspirin 100mg

Clopidogrel + Aspirin + Cilostazol

ACTIVE COMPARATOR

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

Drug: Clopidogrel 75mg; Drug: Aspirin 100mg; Drug: Cilostazol 100mg

Interventions

Clopidogrel 75mg DRUG

Clopidogrel + Aspirin + Cilostazol; Clopidogrel + Aspirit

Clopidogrel 150mg DRUG

Clopidogrel + Aspirin

Aspirin 100mg DRUG

Clopidogrel + Aspirin; Clopidogrel + Aspirin + Cilostazol; Clopidogrel + Aspirit

Cilostazol 100mg DRUG

Clopidogrel + Aspirin + Cilostazol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead
• Beijing Municipal Health Bureau: collaborator
• Haemonetics Corporation: collaborator
• Zhejiang Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

Fuwai Cardiovascular Hospital

Beijing, 100037, China

Location

Fuwai Cardiovascular Hospital

Beijing, China

Location

Related Publications (1)

• 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.

  PMID: 29420189 DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

Clopidogrel; Aspirin; Cilostazol

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Tetrazoles; Azoles; Quinolines

Study Officials

• Yuejin Yang, PHD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 30, 2013
• Study Start: September 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

CN (2)