CompletedPhase 4

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

China296 participantsStarted 2014-09-19

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 oth…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall bleeding events

Timeframe: 18 months

Trial details

NCT IDNCT02206815

SponsorGenshan Ma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02-20

View on ClinicalTrials.gov More Atrial Fibrillation trials