cardiovascular risk diabetes
Conditions
Interventions
Patient will receive either ticagrelor bd orally or corresponding placebo.
Sponsors
Astra Zeneca
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Signed Informed Cosnent 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 MI (with the exception of definite secondary MI [e.g., due to coronary revascularization procedure, profound hypotension, hypertensive emergency, tachycardia, or profound anaemia]) 2. Previous stroke (transient ischaemic attacks [TIA] is not included in the stroke definition) 3. Planned use of ADP receptor antagonists (e.g., clopidogrel, ticlopidine, prasugrel), dipyridamole, or cilostazol. Planned 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 (CYP3A4) inhibitors or CYP3A4 substrates with narrow therapeutic indices that cannot be stopped for the course of the study; * Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir.; * CYP3A4 substrates with narrow therapeutic index: quinidine, simvastatin at doses >40 mg daily or lovastatin at doses >40 mg daily; 6. Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin (at venous thrombosis treatment not prophylaxis doses); 7. Patients with known bleeding diathesis or coagulation disorder, or with uncontrolled hypertension (defined as a systolic BP *180 mmHg and/or diastolic BP *100 mmHg); 8. History of previous intracerebral bleed at any time, gastrointestinal (GI) bleed within the past 6 months, or major surgery within 30 days; 9. Increased risk of bradycardic events (e.g., known sick sinus syndrome, second or third degree AV block or previous documented syncope suspected to be due to bradycardia) unless treated with a pacemaker; 10. Known severe liver disease (e.g., ascites and/or clinical signs of coagulopathy); 11. Renal failure requiring dialysis;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable is time from randomisation to first occurrence of any event from the composite of CV death, MI or stroke (ischaemic, haemorrhagic or unknown etiology). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of the study (presented in hierarchical order) are to compare the effect of long-term treatment with ticagrelor vs. placebo for: 1. Prevention of the composite of all-cause death, MI or stroke. The efficacy variable is time from randomisation to first occurrence of any event from the composite of all-cause death, MI or stroke 2. Prevention of CV death. The efficacy variable is time from randomisation to death of CV cause 3. Prevention of all-cause death. The efficacy variable is time from randomisation to death of any cause. | — |
Countries
Netherlands
Outcome results
None listed