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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
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).
Secondary ID [1] 0 0
D513BC00001
Universal Trial Number (UTN)
Trial acronym
THEMIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of Cardiovascular (CV) Death, MI or Stroke
Timepoint [1] 0 0
From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
Secondary outcome [1] 0 0
CV Death
Timepoint [1] 0 0
From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
Secondary outcome [2] 0 0
MI
Timepoint [2] 0 0
From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
Secondary outcome [3] 0 0
Ischaemic Stroke
Timepoint [3] 0 0
From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
Secondary outcome [4] 0 0
All-cause Death
Timepoint [4] 0 0
From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.

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.

Key
Minimum age
50 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/01/2019
Sample size
Target
Accrual to date
Final
19271
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Ashford
Recruitment hospital [3] 0 0
Research Site - Coffs Harbour
Recruitment hospital [4] 0 0
Research Site - Fitzroy
Recruitment hospital [5] 0 0
Research Site - Fullarton
Recruitment hospital [6] 0 0
Research Site - Geelong
Recruitment hospital [7] 0 0
Research Site - Heidelberg West
Recruitment hospital [8] 0 0
Research Site - Herston
Recruitment hospital [9] 0 0
Research Site - Joondalup
Recruitment hospital [10] 0 0
Research Site - Maroubra
Recruitment hospital [11] 0 0
Research Site - Melbourne
Recruitment hospital [12] 0 0
Research Site - Merewether
Recruitment hospital [13] 0 0
Research Site - Milton
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5035 - Ashford
Recruitment postcode(s) [3] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
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
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
2291 - Merewether
Recruitment postcode(s) [13] 0 0
4064 - Milton
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.
Trial website
https://clinicaltrials.gov/study/NCT01991795
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Philippe Gabriel Steg, MD
Address 0 0
Hôpital Bichat-Claude Bernard 46 Rue Henri Huchard, Paris
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01991795