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

Primary Purpose

Atrial Fibrillation, Coronary Artery Disease

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Ticagrelor+Warfarin

Clopidogrel+Aspirin+Warfarin

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Zhongda Hospital
The forth hospital of Xuzhou
Jiangbin hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Ticagrelor+Warfarin

Clopidogrel+Aspirin+Warfarin

Arm Description

Ticagrelor:Plain, round, yellow, film-coated tablet, 90mg; Warfarin:Plain, round, white, film-coated tablet, 2.5mg

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

Outcomes

Primary Outcome Measures

Overall bleeding events

Secondary Outcome Measures

Major bleeding events

Full Information

NCT ID

NCT02206815

First Posted

July 30, 2014

Last Updated

April 12, 2023

Sponsor

Genshan Ma

Collaborators

Zhongda Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02206815

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

September 19, 2014 (Actual)

Primary Completion Date

February 20, 2019 (Actual)

Study Completion Date

February 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Genshan Ma

Collaborators

Zhongda Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

296 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ticagrelor+Warfarin

Arm Type

Active Comparator

Arm Description

Ticagrelor:Plain, round, yellow, film-coated tablet, 90mg; Warfarin:Plain, round, white, film-coated tablet, 2.5mg

Arm Title

Clopidogrel+Aspirin+Warfarin

Arm Type

Active Comparator

Arm Description

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 Type

Drug

Intervention Name(s)

Ticagrelor+Warfarin

Other Intervention Name(s)

Double antithrombotic therapy

Intervention Description

Ticagrelor 90mg/bid + Warfarin (maintain INR 2.0-2.5)

Intervention Type

Drug

Intervention Name(s)

Clopidogrel+Aspirin+Warfarin

Other Intervention Name(s)

Triple antithrombotic therapy

Intervention Description

Clopidogrel 75mg/day + Aspirin 100mg/day + Warfarin(maintain INR 2.0-2.5)

Primary Outcome Measure Information:

Title

Overall bleeding events

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Major bleeding events

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials: