The effect of Ticagrelor on the CV outcomes of patient with diabetes
Research type
Research Study
Full title
Study title: A Multinational, Randomised, DoubleBlind, PlaceboControlled Trial to Evaluate the Effect of Ticagrelor twice daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients with Type 2 Diabetes Mellitus
IRAS ID
144610
Contact name
Kausik Ray
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2013-003519-23
Clinicaltrials.gov Identifier
Research summary
Cardiovascular (CV) disease and serious CV related complications are common, and the leading cause of death in patients with type 2 diabetes This study evaluates ticagralor as compared to placebo for the prevention of Cardiovascular events (Cardiovascular death, Myocardial Infarction or Stroke) in patients with type 2 diabetes and established coronary artery disease.
The study will include 17000 patients in approximately 950 centres around the world. Patients with type 2 diabetes and relevant eligibility criteria will receive either ticagralor or placebo added onto their background medication.
Once randomised they will be seen for a study visit every 6 months to record any CV events and to check for safety, record changes to relevant medications, check compliance to the study medication, receive more study drug supply and talk to the site staff about dietary and lifestyle advise that could help their diabetes control and other CV risk factors. In addition, between visits, the site will contact the patient by telephone.
As the study is an Endpoint study, the study will finish when the required amount of Endpoints have been recorded. The anticipated duration of the study is up to approximately 3 years, with a recruitment period of approximately 15 months.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
14/WM/0027
Date of REC Opinion
17 Feb 2014
REC opinion
Further Information Favourable Opinion