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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
LOVASTATIN/TICAGRELOR [VA Drug Interaction] Drug: Ticagrelor Drug: full amount low molecular weight heparin Drug: half amount low molecular weight heparin Drug: No low molecular weight heparin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Application of Ticagrelor Combined With Low Molecular Weight Heparin During PCI
Study Start Date : April 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


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 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

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 Name: 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 Name: 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 Name: 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 Name: No enoxaparin




Primary Outcome Measures :
  1. all cause mortality [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Nonfatal myocardial infarction [ Time Frame: one year ]
    Patients occur acute myocardial infarction in a year,but it could not lead to die.

  2. Non-fatal stroke [ Time Frame: one year ]
    Patients occur stroke in a year,but it could not lead to die.

  3. Revascularization again [ Time Frame: one year ]
    Coronary arteries occur stenosis again in a year,the patients are treated with revascularization,including PCI and CABG.

  4. Rehospitalization for ACS or heart failure [ Time Frame: one year ]
    Patients are hospitalized again because of ACS or heart failure in a year.

  5. Bleeding events [ Time Frame: one year ]
    assessing the bleeding events according the TIMI grade.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658838


Locations
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China, Beijing
Beijing Anzhen Hosipital
Beijing, Beijing, China, 100000
Sponsors and Collaborators
Beijing Anzhen Hospital
Investigators
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Study Director: jinghua Liu Beijing Anzhen hosipital
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Responsible Party: Zhao Jing Ye, Principal Investigator, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT02658838    
Other Study ID Numbers: TLPCI
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: August 2015
Additional relevant MeSH terms:
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Heparin
Calcium heparin
Enoxaparin
Heparin, Low-Molecular-Weight
Tinzaparin
Dalteparin
Ticagrelor
Platelet Aggregation Inhibitors
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs