A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01991795 ↗Summary
Linked Publications (5)
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Ticagrelor in Patients with Stable Coronary Disease and Diabetes.
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Limb Outcomes With Ticagrelor Plus Aspirin in Patients With Diabetes Mellitus and Atherosclerosis.
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Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program.
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Assessment of The High risk and unmEt Need in patients with CAD and type 2 diabetes (ATHENA): US healthcare resource use, cost, and burden of illness in a commercially insured population.
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External applicability of the Effect of ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) trial: An analysis of patients with diabetes and coronary artery disease in the REduction of Atherothrombosis for Continued Health (REACH) registry.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite of Cardiovascular (CV) Death, MI or Stroke |
736; 818 | 0.0378 sig |
| SECONDARY CV Death |
364; 357 | 0.7883 |
| SECONDARY MI |
274; 328 | 0.0294 sig |
| SECONDARY Ischaemic Stroke |
152; 191 | 0.0375 sig |
| SECONDARY All-cause Death |
579; 592 | 0.6846 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01991795) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.