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

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ClinicalTrials.gov Identifier: NCT02658838
Recruitment Status : Unknown
Verified August 2015 by Zhao Jing Ye, Beijing Anzhen Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Zhao Jing Ye, Beijing Anzhen Hospital

Tracking Information
First Submitted Date  ICMJE January 13, 2016
First Posted Date  ICMJE January 20, 2016
Last Update Posted Date January 20, 2016
Study Start Date  ICMJE April 2015
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2016)
all cause mortality [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2016)
  • Nonfatal myocardial infarction [ Time Frame: one year ]
    Patients occur acute myocardial infarction in a year,but it could not lead to die.
  • Non-fatal stroke [ Time Frame: one year ]
    Patients occur stroke in a year,but it could not lead to die.
  • Revascularization again [ Time Frame: 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 [ Time Frame: one year ]
    Patients are hospitalized again because of ACS or heart failure in a year.
  • Bleeding events [ Time Frame: one year ]
    assessing the bleeding events according the TIMI grade.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Application of Ticagrelor Combined With Low Molecular Weight Heparin During PCI
Official Title  ICMJE The Application of Ticagrelor Combined With Low Molecular Weight Heparin During PCI
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE LOVASTATIN/TICAGRELOR [VA Drug Interaction]
Intervention  ICMJE
  • Drug: Ticagrelor
    Patients were treated with full amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.
    Other Name: 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 Name: Full amount enoxaparin
  • 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 Name: Half amount enoxaparin
  • 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 Name: No enoxaparin
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Ticagrelor
    • Drug: full amount low molecular weight heparin
  • 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.
    Interventions:
    • Drug: Ticagrelor
    • Drug: half amount low molecular weight heparin
  • 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.
    Interventions:
    • Drug: Ticagrelor
    • Drug: No low molecular weight heparin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 19, 2016)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2017
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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);
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02658838
Other Study ID Numbers  ICMJE TLPCI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhao Jing Ye, Beijing Anzhen Hospital
Study Sponsor  ICMJE Beijing Anzhen Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: jinghua Liu Beijing Anzhen hosipital
PRS Account Beijing Anzhen Hospital
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP