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

Capital Medical University

Status and phase: Unknown; Phase 4

Conditions: LOVASTATIN/TICAGRELOR [VA Drug Interaction]

Treatments: Drug: half amount low molecular weight heparin; Drug: No low molecular weight heparin; Drug: full amount low molecular weight heparin; Drug: Ticagrelor

Study type: Interventional

Funder types: Other

Identifiers

NCT02658838

TLPCI

Details and patient eligibility

About

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

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years old and ≤75 years ;
2. unstable angina, non-ST segment elevation acute myocardial infarction, old myocardial infarction, or confirm the presence of myocardial ischemia;
3. voluntary participation in clinical trials, and informed consent;

Exclusion criteria

1. acute ST segment elevation myocardial infarction, stable angina pectoris;
2. aspirin allergy or resistance;
3. consolidated stroke, chronic obstructive pulmonary disease and other ticagrelor contraindications;
4. patients have coagulopathy;
5. can not be continued for one year with aspirin and treatment of dual antiplatelet ticagrelor;
6. can not complete revascularization;
7. NYHA ≥Ⅲ level or left ventricular ejection fraction <40%;
8. 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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 3 patient groups

full amount low molecular weight heparin

Experimental group

Description:

Patients were treated with ticagrelor one year，After PCI， the patients are treated with full amount low molecular weight heparin until they leave hospital.

Treatment:

Drug: Ticagrelor

Drug: full amount low molecular weight heparin

half amount low molecular weight heparin

Experimental group

Description:

Patients were treated with ticagrelor one year，After PCI， the patients are treated with half amount low molecular weight heparin until they leave hospital.

Treatment:

Drug: Ticagrelor

Drug: half amount low molecular weight heparin

No low molecular weight heparin

Experimental group

Description:

Patients were treated with ticagrelor one year，After PCI， the patients are treated with no low molecular weight heparin.

Treatment:

Drug: Ticagrelor

Drug: No low molecular weight heparin