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

• ClinicalTrials.gov Identifier: NCT02658838
• Recruitment Status: Unknown
• First Posted: January 20, 2016
• Last Update Posted: January 20, 2016
• Sponsor: Beijing Anzhen Hospital
• Information provided by (Responsible Party): Zhao Jing Ye, Beijing Anzhen Hospital

Tracking Information

• First Submitted Date: January 13, 2016
• First Posted Date: January 20, 2016
• Last Update Posted Date: January 20, 2016
• Study Start Date: April 2015
• Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 19, 2016): all cause mortality [ Time Frame: one year ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Application of Ticagrelor Combined With Low Molecular Weight Heparin During PCI
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: LOVASTATIN/TICAGRELOR [VA Drug Interaction]

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 19, 2016): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2017
• Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

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);

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02658838
• Other Study ID Numbers: TLPCI
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Zhao Jing Ye, Beijing Anzhen Hospital
• Study Sponsor: Beijing Anzhen Hospital
• Collaborators: Not Provided

Investigators

• Study Director: jinghua Liu; Beijing Anzhen hosipital

• PRS Account: Beijing Anzhen Hospital
• Verification Date: August 2015