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Safety of "Ticagrelor+ Warfarin"in Comparison With "Clopidogrel+Aspirin+Warfarin"

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ClinicalTrials.gov Identifier: NCT02206815
Recruitment Status : Unknown
Verified May 2016 by Genshan Ma, Southeast University, China.
Recruitment status was:  Recruiting
First Posted : August 1, 2014
Last Update Posted : May 17, 2016
Sponsor:
Collaborator:
Zhongda Hospital
Information provided by (Responsible Party):
Genshan Ma, Southeast University, China

Brief Summary:
The aim of this study was to assess safety of antithrombotic drug ticagrelor plus oral anticoagulation adopted in persistent or permanent AF(Atrial fibrillation) patients(CHA2DS2VASc≥2) after PCI-S with specially regard to the occurrence of major bleeding complications. We hypothesized that baseline characteristics (ie age, anemia, previous major bleeding) and type of antithrombotic regimen could influence any bleeding events and the time of bleeding occurrence. We will test this hypothesis by comparing those AF patients who subsequently received double antithrombotic therapy (Ticagrelor + Warfarin) vs. triple antithrombotic therapy (Clopidogrel + Aspirin + Warfarin) after undergoing PCI-S.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Coronary Artery Disease Drug: Ticagrelor+Warfarin Drug: Clopidogrel+Aspirin+Warfarin Phase 4

Detailed Description:
Currently, the optimal antithrombotic treatment of AF patients with indication for long-term oral anticoagulation undergoing PCI-S is unknown. The randomized trials to assess the best antithrombotic regimen in this setting and the management of this population are challenging. It poses imperative demands for future prospective randomized studies to define the optimal antithrombotic regimen in patients requiring chronic anticoagulation undergoing coronary stenting. Additionally, the vast majority of current clinical studies about antithrombotic therapy for atrial fibrillation together with PCI were retrospectively analysis to date ,whereas the prospective studies are rare and urgently needed

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Ticagrelor Plus Warfarin Versus Clopidogrel+Aspirin+Warfarin in Patients With Persistent or Permanent Atrial Fibrillation and Undergoing PCI-S: A Randomized, Open, Controlled, Parallel Group, Multi-center Trial
Study Start Date : August 2014
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
Active Comparator: Ticagrelor+Warfarin
Ticagrelor:Plain, round, yellow, film-coated tablet, 90mg; Warfarin:Plain, round, white, film-coated tablet, 2.5mg
Drug: Ticagrelor+Warfarin
Ticagrelor 90mg/bid + Warfarin (maintain INR 2.0-2.5)
Other Name: Double antithrombotic therapy

Active Comparator: Clopidogrel+Aspirin+Warfarin
Clopidogrel:Light red bisulfate tablets, containing one 75mg; Aspirin:Plain, round, white, film-coated tablet, 100mg; Warfarin:Plain, round, white, film-coated tablet, 2.5mg
Drug: Clopidogrel+Aspirin+Warfarin
Clopidogrel 75mg/day + Aspirin 100mg/day + Warfarin(maintain INR 2.0-2.5)
Other Name: Triple antithrombotic therapy




Primary Outcome Measures :
  1. Overall bleeding events [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Major bleeding events [ Time Frame: 18 months ]


Information from the National Library of Medicine

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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:

  • Volunteered to participate in this study and signed an informed consent form;
  • Men or non-pregnant women ≥ 18 and ≤75 years of age;
  • Lesion is located in a coronary artery and the need for coronary drug-eluting stent implantation;
  • Patients with persistent or permanent atrial fibrillation;
  • Score of CHA2DS2VASc≥2.

Exclusion Criteria:

  • Severe liver and kidney diseases (GFR<60 ml/min/1.73m2 or CTP≥6 score);
  • Moderate to severe hypertension (after standard antihypertensive therapy, blood pressure higher than 160/100mmHg);
  • Patients with hemodynamic or electrical instability (including shock);
  • Coagulation disorders associated with significant bleeding tendency (eg, hypersensitivity, active bleeding, moderate or severe liver disease, history of previous intracranial bleed, GI bleed within the past 6 months, major surgery within 30 days);
  • Patients with ischemic stroke within one week;
  • Patients with Bronchial asthma, Chronic obstructive pulmonary disease (COPD), and patients with diseases related to dyspnoea;
  • Any contraindication against the use of ticagrelor and other study drugs;
  • Platelet count less than 100 x 109/L;
  • Haemoglobin (Hb) level less than 100 g/L;
  • Researchers involved in the study and / or immediate family members;
  • Participation in another investigation drug or device study in the past 30 days before enrollment;
  • Involvement in the planning and conduct of the study (applies to staffs at study sites);
  • Suffering from other serious disorders and the life expectancy less than half year;
  • Increased risk of bradycardic events (e.g. no pacemaker and known sick sinus syndrome, second degree A-V block, third degree A-V block or previous documented syncope suspected to be due to bradycardia). The Sponsor will review the Holter data in this study to assess the need to continue with this exclusion;
  • Pregnancy or lactation or females of child-bearing potential with the plan of pregnancy in one year;
  • Concomitant oral or intravenous therapy (see examples below) with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers which cannot be stopped for the course of the study (Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir; Substrates with narrow therapeutic index: cyclosporine, quinidine;Strong inducers: rifampin/rifampicin, phenytoin, carbamazepine).

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): NCT02206815


Contacts
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Contact: Wenbin Lu, MD. 025-83262395 zdyyxnk@163.com

Locations
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China, Jiangsu
Zhongda Hospital Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Wenbin Lu, MD.    025-83262395    zdyyxnk@163.com   
The forth hospital of Xuzhou Recruiting
Xuzhou, Jiangsu, China, 0516
Contact: Lulu Sun, MD.    008613813848211    89145990@qq.com   
Jiangbin hospital Recruiting
Zhenjiang, Jiangsu, China, 0511
Contact: Yu Wang, MD.    008613813920978    wangyu757141@sina.com   
Sponsors and Collaborators
Genshan Ma
Zhongda Hospital
Investigators
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Study Director: Genshan Ma, PhD. Southeast University
Principal Investigator: Yu Wang, MD. Southeast University
Principal Investigator: Yuyu Yao, Ph.D Southeast University
Principal Investigator: Wenbin Lu, MD. Southeast University
Principal Investigator: Cong Fu, MD. Southeast University
Principal Investigator: LIjuan Chen, PhD. Southeast University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Genshan Ma, Genshan Ma, MD, PhD, Director of Cardiovascular Institute, Southeast University, Southeast University, China
ClinicalTrials.gov Identifier: NCT02206815     History of Changes
Other Study ID Numbers: ISSBRIL0256
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Warfarin
Atrial Fibrillation
Coronary Artery Disease
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Clopidogrel
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics