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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

Tracking Information
First Submitted Date  ICMJE July 30, 2014
First Posted Date  ICMJE August 1, 2014
Last Update Posted Date May 17, 2016
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2014)
Overall bleeding events [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02206815 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2014)
Major bleeding events [ Time Frame: 18 months ]
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 Safety of "Ticagrelor+ Warfarin"in Comparison With "Clopidogrel+Aspirin+Warfarin"
Official Title  ICMJE 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
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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Coronary Artery Disease
Intervention  ICMJE
  • Drug: Ticagrelor+Warfarin
    Ticagrelor 90mg/bid + Warfarin (maintain INR 2.0-2.5)
    Other Name: Double antithrombotic therapy
  • Drug: Clopidogrel+Aspirin+Warfarin
    Clopidogrel 75mg/day + Aspirin 100mg/day + Warfarin(maintain INR 2.0-2.5)
    Other Name: Triple antithrombotic therapy
Study Arms  ICMJE
  • Active Comparator: Ticagrelor+Warfarin
    Ticagrelor:Plain, round, yellow, film-coated tablet, 90mg; Warfarin:Plain, round, white, film-coated tablet, 2.5mg
    Intervention: Drug: Ticagrelor+Warfarin
  • 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
    Intervention: Drug: Clopidogrel+Aspirin+Warfarin
Publications * Lu W, Chen L, Wang Y, Yao Y, Fu C, Zuo P, Ma G. Rationale and design of MANJUSRI trial: a randomized, open-label, active-controlled multicenter study to evaluate the safety of combined therapy with ticagrelor and warfarin in AF subjects after PCI-eS. Contemp Clin Trials. 2015 Jan;40:166-71. doi: 10.1016/j.cct.2014.12.002. Epub 2014 Dec 13.

*   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: July 30, 2014)
296
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2018
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
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 NCT02206815
Other Study ID Numbers  ICMJE ISSBRIL0256
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Genshan Ma, Southeast University, China
Study Sponsor  ICMJE Genshan Ma
Collaborators  ICMJE Zhongda Hospital
Investigators  ICMJE
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
PRS Account Southeast University, China
Verification Date May 2016

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