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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

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. Time from randomisation to first occurrence of any event from the composite of CV death, MI or stroke [ Time Frame: Up to 58 months ]

Secondary Outcome Measures :
  1. Prevention of CV death. The efficacy variable is time from randomisation to death of CV cause [ Time Frame: Up to 58 months ]
  2. Prevention of MI. The efficacy variable is time from randomisation to first occurrence of MI [ Time Frame: Up to 58 months ]
  3. Prevention of ischaemic stroke. The efficacy variable is time from randomisation to first occurrence of ischaemic stroke [ Time Frame: Up to 58 months ]
  4. Prevention of all-cause death. The efficacy variable is time from randomisation to death of any cause [ Time Frame: Up to 58 months ]

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
More Information
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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
Last Update Posted: February 15, 2019
Last Verified: February 2019
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