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

NCT ID: NCT02658838

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-09-30

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.

Conditions

LOVASTATIN/TICAGRELOR [VA Drug Interaction]

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ticagrelor

Intervention Type: DRUG

Patients were treated with full amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.

full amount low molecular weight heparin

Intervention Type: DRUG

Patients were treated with half amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.

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.

Group Type: EXPERIMENTAL

Ticagrelor

Intervention Type: DRUG

Patients were treated with full amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.

half amount low molecular weight heparin

Intervention Type: DRUG

Patients were treated with half amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.

No low molecular weight heparin

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

Group Type: EXPERIMENTAL

Ticagrelor

Intervention Type: DRUG

Patients were treated with full amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.

No low molecular weight heparin

Intervention Type: DRUG

Patients were treated with no low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.

Interventions

Ticagrelor

Patients were treated with full amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.

Intervention Type: DRUG

full amount low molecular weight heparin

Patients were treated with half amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.

Intervention Type: DRUG

half amount low molecular weight heparin

Patients were treated with half amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.

Intervention Type: DRUG

No low molecular weight heparin

Patients were treated with no low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.

Intervention Type: DRUG

Other Intervention Names

Antiplatelet drugs; Full amount enoxaparin; Half amount enoxaparin; No enoxaparin

Eligibility Criteria

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);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Jing Ye

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

jinghua Liu

Role: STUDY_DIRECTOR

Beijing Anzhen hosipital

Locations

Beijing Anzhen Hosipital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

TLPCI

Identifier Type: -

Identifier Source: org_study_id