The Application of Ticagrelor Combined With Low Molecular Weight Heparin During PCI

Study Overview
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Brief Summary
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The purpose of this study is to determine ticagrelor combining with low molecular weight heparin is effective and safe during PCI or not.

Detailed Description
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Ticagrelor is a new drug compared with clopidogrel. It has a stronger antiplatelet capacity. After PCI，whether using low molecular weight heparin can make patients better prognosis or not, What's more，full amount or half amount low molecular weight heparin?, also investigators want to explore that whether it may lead to more bleeding events.

Official Title
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The Application of Ticagrelor Combined With Low Molecular Weight Heparin During PCI

Conditions
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LOVASTATIN/TICAGRELOR [VA Drug Interaction]

Intervention / Treatment
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* Drug: Ticagrelor
* Drug: full amount low molecular weight heparin
* Drug: half amount low molecular weight heparin
* Drug: No low molecular weight heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old and ≤75 years ; unstable angina, non-ST segment elevation acute myocardial infarction, old myocardial infarction, or confirm the presence of myocardial ischemia; voluntary participation in clinical trials, and informed consent; Exclusion Criteria: acute ST segment elevation myocardial infarction, stable angina pectoris; aspirin allergy or resistance; consolidated stroke, chronic obstructive pulmonary disease and other ticagrelor contraindications; patients have coagulopathy; can not be continued for one year with aspirin and treatment of dual antiplatelet ticagrelor; can not complete revascularization; NYHA ≥Ⅲ level or left ventricular ejection fraction <40%; severe liver and kidney dysfunction (ALT and AST were more than three times the upper limit of normal, creatinine clearance less than 30ml / min-1.1.72m-2);

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: full amount low molecular weight heparin<br>Patients were treated with ticagrelor one year，After PCI， the patients are treated with full amount low molecular weight heparin until they leave hospital. | Drug: Ticagrelor<br>* Patients were treated with full amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.<br>* Other names: Antiplatelet drugs;Drug: full amount low molecular weight heparin<br>* Patients were treated with half amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.<br>* Other names: Full amount enoxaparin;|
| Experimental: half amount low molecular weight heparin<br>Patients were treated with ticagrelor one year，After PCI， the patients are treated with half amount low molecular weight heparin until they leave hospital. | Drug: Ticagrelor<br>* Patients were treated with full amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.<br>* Other names: Antiplatelet drugs;Drug: half amount low molecular weight heparin<br>* Patients were treated with half amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.<br>* Other names: Half amount enoxaparin;|
| Experimental: No low molecular weight heparin<br>Patients were treated with ticagrelor one year，After PCI， the patients are treated with no low molecular weight heparin. | Drug: Ticagrelor<br>* Patients were treated with full amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.<br>* Other names: Antiplatelet drugs;Drug: No low molecular weight heparin<br>* Patients were treated with no low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.<br>* Other names: No enoxaparin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nonfatal myocardial infarction | Patients occur acute myocardial infarction in a year，but it could not lead to die. | one year | 
| Non-fatal stroke | Patients occur stroke in a year，but it could not lead to die. | one year | 
| Revascularization again | Coronary arteries occur stenosis again in a year，the patients are treated with revascularization，including PCI and CABG. | one year | 
| Rehospitalization for ACS or heart failure | Patients are hospitalized again because of ACS or heart failure in a year. | one year | 
| Bleeding events | assessing the bleeding events according the TIMI grade. | one year |