Overview

This trial is active, not recruiting.

Condition lovastatin/ticagrelor [va drug interaction]
Treatments ticagrelor, full amount low molecular weight heparin, half amount low molecular weight heparin, no low molecular weight heparin
Phase phase 4
Sponsor Beijing Anzhen Hospital
Start date April 2015
End date August 2016
Trial size 300 participants
Trial identifier NCT02658838, TLPCI

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Patients were treated with ticagrelor one year,After PCI, the patients are treated with full amount low molecular weight heparin until they leave hospital.
ticagrelor Antiplatelet drugs
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 Full amount enoxaparin
Patients were treated with half amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.
(Experimental)
Patients were treated with ticagrelor one year,After PCI, the patients are treated with half amount low molecular weight heparin until they leave hospital.
ticagrelor Antiplatelet drugs
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 Half amount enoxaparin
Patients were treated with half amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.
(Experimental)
Patients were treated with ticagrelor one year,After PCI, the patients are treated with no low molecular weight heparin.
ticagrelor Antiplatelet drugs
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 No enoxaparin
Patients were treated with no low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.

Primary Outcomes

Measure
all cause mortality
time frame: one year

Secondary Outcomes

Measure
Nonfatal myocardial infarction
time frame: one year
Non-fatal stroke
time frame: one year
Revascularization again
time frame: one year
Rehospitalization for ACS or heart failure
time frame: one year
Bleeding events
time frame: one year

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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);

Additional Information

Official title The Application of Ticagrelor Combined With Low Molecular Weight Heparin During PCI
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Beijing Anzhen Hospital.