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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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);

Contacts and Locations

Locations

China, Beijing

Beijing Anzhen Hosipital

Beijing, Beijing, China, 100000

Sponsors and Collaborators

Beijing Anzhen Hospital

Investigators

• Study Director: jinghua Liu; Beijing Anzhen hosipital

More Information

• Responsible Party: Zhao Jing Ye, Principal Investigator, Beijing Anzhen Hospital
• ClinicalTrials.gov Identifier: NCT02658838
• Other Study ID Numbers: TLPCI
• First Posted: January 20, 2016
• Last Update Posted: January 20, 2016
• Last Verified: August 2015

Additional relevant MeSH terms:

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