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

Phase 4

• Conditions: LOVASTATIN/TICAGRELOR [VA Drug Interaction]
• Interventions: Drug: Ticagrelor; Drug: half amount low molecular weight heparin; Drug: full amount low molecular weight heparin; Drug: No low molecular weight heparin

• Registration Number: NCT02658838
• Lead Sponsor: Beijing Anzhen Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-04
• Status Verified: 2015-08
• Study First Submitted: 2016-01-13
• Study First Submitted QC: 2016-01-19
• Last Update Submitted: 2016-01-19
• Study First Posted: 2016-01-20
• Last Update Posted: 2016-01-20
• Primary Completion: 2016-08
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
half amount low molecular weight heparin	half amount low molecular weight heparin	Patients were treated with ticagrelor one year，After PCI， the patients are treated with half amount low molecular weight heparin until they leave hospital.
No low molecular weight heparin	Ticagrelor	Patients were treated with ticagrelor one year，After PCI， the patients are treated with no low molecular weight heparin.
full amount low molecular weight heparin	full amount low molecular weight heparin	Patients were treated with ticagrelor one year，After PCI， the patients are treated with full amount low molecular weight heparin until they leave hospital.
No low molecular weight heparin	No low molecular weight heparin	Patients were treated with ticagrelor one year，After PCI， the patients are treated with no low molecular weight heparin.
full amount low molecular weight heparin	Ticagrelor	Patients were treated with ticagrelor one year，After PCI， the patients are treated with full amount low molecular weight heparin until they leave hospital.
half amount low molecular weight heparin	Ticagrelor	Patients were treated with ticagrelor one year，After PCI， the patients are treated with half amount low molecular weight heparin until they leave hospital.

Primary Outcome Measures

Name	Time	Method
all cause mortality	one year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Anzhen Hosipital; 🇨🇳 Beijing, Beijing, China