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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01991795
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : March 18, 2020
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Ticagrelor 60 mg Drug: Ticagrelor placebo Phase 3

Detailed Description:
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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19271 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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).
Actual Study Start Date : February 10, 2014
Actual Primary Completion Date : January 25, 2019
Actual Study Completion Date : January 25, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ticagrelor 60 mg
Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
 Drug: Ticagrelor 60 mg
Ticagrelor 60 mg bd taken orally as tablets
Other Name: Brilinta/Brilique
Placebo Comparator: Ticagrelor placebo
Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
 Drug: Ticagrelor placebo
Ticagrelor placebo bd taken orally as tablets


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991795


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Philippe Gabriel Steg, MD Hôpital Bichat-Claude Bernard 46 Rue Henri Huchard, Paris
Principal Investigator: Deepak L. Bhatt, MD Brigham and Women's Hospital75 Francis Street, Boston
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Study Protocol  [PDF] February 7, 2017
Statistical Analysis Plan  [PDF] September 17, 2018

More Information
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Additional Information:
D513BC00001_CSP_redacted  This link exits the ClinicalTrials.gov site D513BC00001_SAP_redacted  This link exits the ClinicalTrials.gov site

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01991795    
Other Study ID Numbers: D513BC00001
First Posted: November 25, 2013    Key Record Dates
Results First Posted: March 18, 2020
Last Update Posted: March 18, 2020
Last Verified: March 2020
Keywords provided by AstraZeneca:
Diabetes
Coronary artery disease
Outcome
Prevention
Antiplatelet
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ticagrelor
Platelet Aggregation Inhibitors
 Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs