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Safety of "Ticagrelor+ Warf" in compairation with "Clopi+Aspirin+Warf"

Safetyof Ticagrelor plus Warfarin versus Traditional Triple Antithrombotic Therpay Regimen in Patients with Persistent or Permanent Atrial Fibrillation and undergoing PCI-S: A Randomized, Open, Controlled, Parallel Group, Multi-center Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004992
Enrollment
Unknown
Registered
2014-05-04
Start date
2014-08-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent or Permanent Atrial Fibrillation and Coronary artery disease

Interventions

Control:Clopidogrel + Aspirin + Warfarin
experimental:Ticagrelor + Warfarin

Sponsors

ZhongDa Hospital affiliated to Southeast University China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Volunteered to participate in this study and signed an informed consent form; 2. Men or non-pregnant women aged from 18 to 75 years of age; 3. Lesion is located in a coronary artery and the need for coronary drug-eluting stent implantation; 4. Patients with persistent or permanent atrial fibrillation; 5. Score of CHA2DS2VASc more than 2.

Exclusion criteria

Exclusion criteria: 1. Severe liver and kidney diseases (GFR less than 60 ml/min/1.73m^2 or CTP more than 6 score); 2. Moderate to severe hypertension (after standard antihypertensive therapy, blood pressure higher than 160/100mmHg); 3. Patients with hemodynamic or electrical instability (including shock); 4. 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); 5. Patients with ischemic stroke within one week; 6. Patients with Bronchial asthma, Chronic obstructive pulmonary disease (COPD), and patients with diseases related to dyspnoea; 7. Any contraindication against the use of ticagrelor and other study drugs; 8. Platelet count less than 100*10^9/L; 9. Haemoglobin (Hb) level less than 100 g/L; 10. Researchers involved in the study and / or immediate family members; 11. Participation in another investigation drug or device study in the past 30 days before enrollment; 12. Involvement in the planning and conduct of the study (applies to staffs at study sites); 13. Suffering from other serious disorders and the life expectancy less than half year; 14. 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; 15. Pregnancy or lactation or females of child-bearing potential with the plan of pregnancy in one year; 16. 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).

Design outcomes

Primary

MeasureTime frame
Overall Bleeding;

Secondary

MeasureTime frame
Major Bleeding;

Countries

China

Contacts

Public ContactGenshan Ma
magenshan@hotmail.com+86 13002580569

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026