Last updated on February 2018

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Atrial Fibrillation | Coronary Artery Disease | Coronary heart disease
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

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 CHA2DS2VASc2.

Exclusion Criteria:

  • Severe liver and kidney diseases (GFR<60 ml/min/1.73m2 or CTP6 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, quinidineStrong inducers: rifampin/rifampicin, phenytoin, carbamazepine).

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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