None listed
Conditions
Interventions
Ticagrelor 90 mg bd given orally and corresponding placebo.
Men and women ≥
50 years of age with T2DM at high risk of CV events, but without a medical history of previous MI or stroke.
Sponsors
ASTRAZENECA - PERU,
Eligibility
Sex/Gender
All
Age
50 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures. 2. Men or women ≥50 years of age. 3. Diagnosed with T2DM defined by ongoing glucose lowering drug treatment prescribed by a physician for treatment of T2DM since at least 6 months prior to Visit 1. 4. At high risk of CV events, defined as history of percutaneous coronary intervention or coronary artery bypass graft or angiographic evidence of ≥ 50% lumen stenosis of at least 1 coronary artery.
Exclusion criteria
Exclusion criteria: 1. Previous Miocardial Infarction. 2. Previous stroke. 3. Planned use of ADP receptor antagonists and/or use of ASA treatment at doses >150 mg od. 4. Planned coronary, cerebrovascular, or peripheral arterial revascularization 5. Anticipated concomitant oral or intravenous therapy with strong cytochrome P450 3A4 nhibitors or CYP3A4 substrates that cannot be stopped for the course of the study. 6. Need for chronic oral anticoagulant therapy or low-molecular-weight heparin. 7. Patients with known bleeding diathesis or coagulation disorder, or with uncontrolled hypertension. 8. History of previous intracerebral bleed, gastrointestinal bleed within the past 6 months prior to randomisation, or major surgery within 30 days prior to randomisation. 9. Increased risk of bradycardic events unless treated with a pacemaker. 10. Known severe liver disease. 11. Renal failure requiring dialysis. 12. Women of child-bearing potential who are not willing to use a accepted method of contraception OR women who have a positive pregnancy test at enrolment OR women who are breast-feeding. 13. Inability of the patient to understand and/or comply with study procedures. 14. Any condition which in the opinion of the investigator would make it unsafe for the patient to participate in this study. 15. Participation in another clinical study with an investigational product within 28 days prior to enrolment. 16. Involvement in the planning and/or conduct of the study.
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, Korea South, Mexico, Netherlands, Peru, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kindgdom, United States, Vietnam
Contacts
Public ContactCarlos Alonso Arbulu
ASTRAZENECA PERU S.A.
Outcome results
None listed