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

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ClinicalTrials.gov Identifier: NCT01991795
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE November 18, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE February 10, 2014
Actual Primary Completion Date January 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
Time from randomisation to first occurrence of any event from the composite of CV death, MI or stroke [ Time Frame: Up to 58 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
Time from randomisation to first occurrence of any event from the composite of CV death, MI or stroke [ Time Frame: Up to 35 months ]
Change History Complete list of historical versions of study NCT01991795 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
  • Prevention of CV death. The efficacy variable is time from randomisation to death of CV cause [ Time Frame: Up to 58 months ]
  • Prevention of MI. The efficacy variable is time from randomisation to first occurrence of MI [ Time Frame: Up to 58 months ]
  • Prevention of ischaemic stroke. The efficacy variable is time from randomisation to first occurrence of ischaemic stroke [ Time Frame: Up to 58 months ]
  • Prevention of all-cause death. The efficacy variable is time from randomisation to death of any cause [ Time Frame: Up to 58 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
  • Time from randomisation to first occurrence of any event from the composite of all-cause death, MI or stroke [ Time Frame: Up to 35 months ]
  • Time from randomisation to death of CV cause [ Time Frame: Up to 35 months ]
  • Time from randomisation to death of any cause [ Time Frame: Up to 35 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus
Official Title  ICMJE 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)
Brief Summary The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Ticagrelor 60 mg
    Ticagrelor 60 mg bd taken orally as tablets
    Other Name: Brilinta/Brilique
  • Drug: Ticagrelor placebo
    Ticagrelor placebo bd taken orally as tablets
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Ticagrelor 60 mg
  • 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.
    Intervention: Drug: Ticagrelor placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2019)
19271
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2013)
17000
Actual Study Completion Date  ICMJE January 25, 2019
Actual Primary Completion Date January 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile,   Russian Federation,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   Colombia,   Czechia,   Denmark,   Finland,   France,   Germany,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Peru,   Philippines,   Poland,   Puerto Rico,   Romania,   Saudi Arabia,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States,   Vietnam
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01991795
Other Study ID Numbers  ICMJE D513BC00001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account AstraZeneca
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP