Global Leaders Study V1.0
Research type
Research Study
Full title
GLOBAL LEADERS: Comparative effectiveness of 1 month of ticagrelor plus aspirin followed by ticagrelor monotherapy versus a current-day intensive dual antiplatelet therapy in all-comers patients undergoing percutaneous coronary intervention with bivalirudin and BioMatrix family drug-eluting stent use.
IRAS ID
125941
Contact name
Rodney Stables
Contact email
Sponsor organisation
European Cardiovascular Research Institute
Eudract number
2012-003515-58
Research summary
The study aims to determine whether treatment with 1 month of ticagrelor and aspirin followed by 23 months of a drug called ticagrelor on its own is superior to treatment with 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin in reducing patient death and patients having heart attacks.
This study is looking at patients with a narrowing of their coronary artery (coronary artery stenoses), resulting in a poor blood flow to the heart (Stenoses is a narrowing or blockage of a blood vessel).
The study will recruit patients who are at least 18 years old, have one or more coronary artery stenoses which is 50% or more blocked that is suitable for coronary stent implantation (A stent is a metallic scaffold that is expanded and “plastered” against the blood vessel wall to keep it open) and they are able to provide informed consent and are willing to participate in 2 year follow-up period. The patients cannot have an intolerance to any of the drugs they will receive or have any major bleeding, major surgery a stroke 30 days prior to starting the trial, be pregnant or be involved in another clinical trial.
The study will be conducted in hospitals in the UK.
The study is 2 years long from the point when the patient has the first stent put in place.
Throughout the patients hospital stay, patients will be monitored. Data will be collected about the patient’s medical status. Also at discharge, an electrocardiogram (ECG/EKG) will be recorded. After being discharged from the hospital, patients will be asked to return to the hospital for a follow-up at 1 month, 3 months, 6 months, 1 year, 1.5 years and 2 years. During the 3month and 2 year visits, ECG’s/EKG’s will be recorded.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0283
Date of REC Opinion
10 Jun 2013
REC opinion
Further Information Favourable Opinion