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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01991795
Registration number
NCT01991795
Ethics application status
Date submitted
18/11/2013
Date registered
25/11/2013
Date last updated
18/03/2020
Titles & IDs
Public title
A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus
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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).
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Secondary ID [1]
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D513BC00001
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Universal Trial Number (UTN)
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Trial acronym
THEMIS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ticagrelor 60 mg
Treatment: Drugs - Ticagrelor placebo
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.
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.
Treatment: Drugs: Ticagrelor 60 mg
Ticagrelor 60 mg bd taken orally as tablets
Treatment: Drugs: Ticagrelor placebo
Ticagrelor placebo bd taken orally as tablets
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Composite of Cardiovascular (CV) Death, MI or Stroke
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Assessment method [1]
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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.
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Timepoint [1]
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From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
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Secondary outcome [1]
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CV Death
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Assessment method [1]
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Participants with Cardiovascular (CV) death. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date.
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Timepoint [1]
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From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
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Secondary outcome [2]
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MI
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Assessment method [2]
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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
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Timepoint [2]
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From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
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Secondary outcome [3]
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Ischaemic Stroke
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Assessment method [3]
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Participants with ischaemic stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and death date.
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Timepoint [3]
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From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
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Secondary outcome [4]
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All-cause Death
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Assessment method [4]
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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.
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Timepoint [4]
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From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
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Eligibility
Key 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.
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Minimum age
50
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Maximum age
130
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/02/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
25/01/2019
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Sample size
Target
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Final
19271
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Recruitment in Australia
Recruitment state(s)
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Research Site - Adelaide
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5000 - Adelaide
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5035 - Ashford
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2450 - Coffs Harbour
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3065 - Fitzroy
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5063 - Fullarton
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3220 - Geelong
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3081 - Heidelberg West
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4029 - Herston
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6027 - Joondalup
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2035 - Maroubra
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3004 - Melbourne
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2291 - Merewether
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Recruitment postcode(s) [13]
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4064 - Milton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT01991795
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Philippe Gabriel Steg, MD
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Address
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Hôpital Bichat-Claude Bernard 46 Rue Henri Huchard, Paris
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/95/NCT01991795/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/95/NCT01991795/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01991795
Download to PDF