A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01991795
• Date of registration: 18/11/2013
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus THEMIS
• Scientific title: A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor 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).
• Date of first enrolment: February 10, 2014
• Target sample size: 19271
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01991795
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Deepak L. Bhatt, MD
• Affiliation: Brigham and Women's Hospital75 Francis Street, Boston

• Name: Philippe Gabriel Steg, MD
• Affiliation: Hôpital Bichat-Claude Bernard 46 Rue Henri Huchard, Paris

Key inclusion & exclusion criteria

Inclusion Criteria:

Men or women =50 years of age with type 2 diabetes mellitus on treatment with a glucose
lowering medication since at least 6 months, and either documented coronary artery
occlusive disease or previous revascularization of a coronary artery.

Key Exclusion Criteria:

History of myocardial infarction or any stroke; planned treatment with agents inhibiting
blood clotting; planned use of ASA/Aspirin at doses above 150 mg daily; planned coronary,
cerebrovascular, or peripheral arterial revascularization; patients with known bleeding
disorders and patients who need chronic oral anticoagulant therapy or chronic
low-molecular-weight heparin; history of intracranial bleeding at any time, or a history of
bleeding from the gastrointestinal tract within the last 6 months or a major surgery within
the last 30 days; patients with known severe liver disease or with kidney failure requiring
dialysis



Age minimum: 50 Years
Age maximum: 130 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: Ticagrelor 60 mg

Drug: Ticagrelor placebo

Primary Outcome(s)

Composite of Cardiovascular (CV) Death, MI or Stroke [Time Frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.]

Secondary Outcome(s)

CV Death [Time Frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.]

Ischaemic Stroke [Time Frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.]

MI [Time Frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.]

All-cause Death [Time Frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.]

Secondary ID(s)

D513BC00001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/03/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01991795