major cardiovascular events in type 2 diabetes mellitus patients MedDRA version: 16.1 Level: LLT Classification code 10042244 Term: Stroke System Organ Class: 100000004852 MedDRA version: 16.1 Level: PT Classification code 10028596 Term: Myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: BRILIQUE
Product Name: Ticagrelor 90mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ticagrelor
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men or women > or = 50 years of age 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 At high risk of CV events, defined as history of percutaneous coronary intervention or coronary artery bypass graft or angiographic evidence of > or = 50% lumen stenosis of at least 1 coronary artery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8500
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 > or = 180 mmHg and/or diastolic BP > or = 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 |
|---|---|
| Primary end point(s): Time from randomisation to first occurrence of any event from the composite of CV death, MI or stroke (ischaemic, haemorrhagic or unknown etiology).;Timepoint(s) of evaluation of this end point: Up to approximately 35 months.; Main Objective: The primary objective of the study is to compare the effect of long-term treatment with ticagrelor 90 mg twice daily (bd) vs. placebo for the prevention of major cardiovascular (CV) events (composite of CV death, myocardial infarction [MI] or stroke) in patients with Type 2 Diabetes Mellitus (T2DM) at high risk for CV events, but without a previous medical history of MI or stroke. 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 Objective: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time from randomisation to first occurrence of any event from the composite of all-cause death, MI or stroke. Time from randomisation to death of CV cause. Time from randomisation to death of any cause. ;Timepoint(s) of evaluation of this end point: Up to approximately 35 months. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Vietnam
Contacts
Public ContactUnidad de Investigación Clínica
AstraZeneca Farmacéutica Spain, S.A.
Outcome results
None listed