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 |
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Recruitment Status :
Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : October 4, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus, Type 2 | Drug: Ticagrelor 60 mg Drug: Ticagrelor placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 19349 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 |
| Estimated Primary Completion Date : | December 28, 2018 |
| Estimated Study Completion Date : | December 28, 2018 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Ticagrelor 60 mg
Ticagrelor 60 mg bd taken orally as tablets
Other Name: Brilinta/Brilique |
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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.
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Drug: Ticagrelor placebo
Ticagrelor placebo bd taken orally as tablets |
- Time from randomisation to first occurrence of any event from the composite of CV death, MI or stroke [ Time Frame: Up to 58 months ]
- 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 ]
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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 |
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
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
Show 1244 Study Locations
| 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01991795 History of Changes |
| Other Study ID Numbers: |
D513BC00001 |
| First Posted: | November 25, 2013 Key Record Dates |
| Last Update Posted: | October 4, 2018 |
| Last Verified: | October 2018 |
Keywords provided by AstraZeneca:
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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 Adenosine Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Vasodilator Agents Purinergic P1 Receptor Agonists Purinergic Agonists |