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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Beijing Anzhen Hosipital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Ticagrelor; Patients were treated with full amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.; Other Names: Antiplatelet drugs; 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.; Other Names: Full amount enoxaparin
EXPERIMENTAL: 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.	Drug: Ticagrelor; Patients were treated with full amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.; Other Names: Antiplatelet drugs; 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.; Other Names: Half amount enoxaparin
EXPERIMENTAL: No low molecular weight heparin; Patients were treated with ticagrelor one year，After PCI， the patients are treated with no low molecular weight heparin.	Drug: Ticagrelor; Patients were treated with full amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.; Other Names: Antiplatelet drugs; 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.; Other Names: No enoxaparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Investigators: Study Director: jinghua Liu, Beijing Anzhen Hosipital

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (ANTICIPATED): August 1, 2016
• Study Completion (ANTICIPATED): September 1, 2017

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: January 19, 2016
• First Posted (ESTIMATE): January 20, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): January 20, 2016
• Last Update Submitted That Met QC Criteria: January 19, 2016
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Anticoagulants; Ticagrelor; Heparin; Enoxaparin; Calcium heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Enoxaparin sodium; Platelet Aggregation Inhibitors
• Other Study ID Numbers: TLPCI