Multicenter Trial to evaluate if Ticagrelor is effective in preventing the occurrence of heart attack, stroke and/or death due to cardiovascular events in patients who have type 2 diabetes ( THEMIS) and if so how it compares with placebo with a background of Aspirin therapy

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: effect of Ticagrelor on Health outcomes in diabEtes Mellitus patients Intervention Study] - THEMIS

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/01/006480

Enrollment

17000

Registered

2016-01-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Men and women equal - greater than 50 years old with T2DM at high risk of CV events, but without a medical history of previous MI or stroke. Health Condition 2: E118- Type 2 diabetes mellitus with unspecified complications

Interventions

Intervention1: Ticagrelor: one tablet bd given orally Control Intervention1: Placebo OD: one tablet bd given orally

Eligibility

Inclusion criteria

Inclusion criteria: • Provision of informed consent prior to any study specific procedures • Female or male aged equal - greater than 50 years old • Diagnosed with Type 2 Diabetes with High Risk for Cardiovascular events with defined as history of percutaneous coronary intervention or coronary artery bypass graft or angiographic evidence of equal - greater than 50% lumen stenosis of at least 1 coronary artery.

Exclusion criteria

Exclusion criteria: • Previous MI • Previous Stroke • Known severe liver disease (e.g., ascites and/or clinical signs of coagulopathy) • Women of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopause) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomisation OR women who are breast-feeding

Design outcomes

Primary

Measure	Time frame
Time to first event included in the composite endpoint of CV death, MI or ischemic strokeTimepoint: Time to first event included in the composite endpoint of CV death, MI or ischemic stroke	—

Secondary

Measure	Time frame
Time to Prevention of the composite of all-cause death, MI or stroke. Time to Prevention of CV death Time to Prevention of all-cause death Timepoint: Time to Prevention of the composite of all-cause death, MI or stroke. Time to Prevention of CV death Time to Prevention of all-cause death	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Republic of Korea, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States of America, Viet Nam

Contacts

Public ContactMr Tapankumar Shah

AstraZeneca Pharma India Ltd.

tapankumar.shah@astrazeneca.com9535104975

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026