A MULTINATIONAL, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFECT OF TICAGRELOR 90 MG TWICE DAILY ON THE INCIDENCE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION OR STROKE IN PATIENTS WITH TYPE 2 DIABETES MELLITUS (THEMIS)

Not Applicable

Completed

• Conditions: -E11 Non-insulin-dependent diabetes mellitus; Non-insulin-dependent diabetes mellitus; E11

• Registration Number: PER-089-13
• Lead Sponsor: ASTRAZENECA - PERU,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-11
• Study Completion: 2018-12-18
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 173

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified