Status:
COMPLETED
Safety of "Ticagrelor+ Warfarin"in Comparison With "Clopidogrel+Aspirin+Warfarin"
Lead Sponsor:
Genshan Ma
Collaborating Sponsors:
Zhongda Hospital
Conditions:
Atrial Fibrillation
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 wi...
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 r...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 19 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2019
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT02206815
Start Date
September 19 2014
End Date
February 20 2019
Last Update
April 14 2023
Active Locations (3)
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1
Zhongda Hospital
Nanjing, Jiangsu, China, 210009
2
The forth hospital of Xuzhou
Xuzhou, Jiangsu, China, 0516
3
Jiangbin hospital
Zhenjiang, Jiangsu, China, 0511