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Completed

NCT Number: NCT01991795

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

The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.

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Key information

Conditions

Diabetes Mellitus, Type 2 Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

50 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

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About this study

A multinational, randomised, double-blind, placebo-controlled phase IIIb 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor 60 mg

Drug

Ticagrelor 60 mg bd taken orally as tablets

Other names: Brilinta/Brilique

Ticagrelor Placebo

Drug

Ticagrelor placebo bd taken orally as tablets

Primary outcomes

  1. 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.

    Participants with Cardiovascular (CV) death, myocardial infarction (MI) or stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date.

Secondary outcomes

  1. CV Death

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

    Participants with Cardiovascular (CV) death. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date.

  2. MI

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

    Participants with myocardial infarction. If no event, censoring occurs at the earliest of primary analysis censoring date (PACD), last endpoint assessment date and death date

  3. Ischaemic Stroke

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

    Participants with ischaemic stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and death date.

  4. All-cause Death

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

    Participants with all-cause death. If no event, censoring occurs at the earliest of PACD and last endpoint assessment date. Includes deaths based on publically available vital status data in patients who have withdrawn consent.

Other outcomes

  1. TIMI Major Bleeding Event (Primary Safety Objective)

    Time frame: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

    Participants with TIMI major bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication

  2. TIMI Major or Minor Bleeding Event

    Time frame: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

    Participants with TIMI major or minor bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication

  3. PLATO Major Bleeding Event

    Time frame: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

    Participants with PLATO major bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication

  4. Permanent Discontinuation of Study Medication Due to Any Bleeding Event

    Time frame: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

    Participants with permanent discontinuation of study medication due to any bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and the date of last dose of study medication

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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).

Acronym: THEMIS

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Nov 25, 2013
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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