Type-2 Diabetes Mellitus | Ticagrelor Versus Clopidogrel in Type 2 Diabetic Patients
Type-2 Diabetes Mellitus research study
What is the primary objective of this study?
The purpose of this study is to determine whether treatment with ticagrelor + aspirin is more effective than treatment with clopidogrel + aspirin in patients with type-2 diabetes. Both treatments will be given (separately) to all subjects as a one-time loading dose (i.e. higher than a normal daily dose), followed by daily dose for the next 5 to 7 days. Effectiveness of treatment will be measured with specialized blood tests before the loading dose, at two time-points after the loading dose, and once after the last daily dose.
Who is eligible to participate?
Inclusion Criteria: - Diagnosed with type-2 diabetes being treated with oral or parenteral hypoglycemic therapy or both. - Have not had thienopyridine therapy for at least 30 days before the study. - Are of legal age (at least 18 years of age but less than 75 years of age) and competent mental condition to provide written informed consent. - For women of child-bearing potential only test negative for pregnancy at the time of enrollment. Exclusion Criteria: - Have a defined need for thienopyridine therapy. - Subjects within ≤30 days of coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI). - Known glycosylated hemoglobin (HbA1c) ≥10 mg/dL within last 3 months prior to study entry. - Have received fibrinolytic therapy <48 hours prior to randomization. - Have active internal bleeding or history of bleeding diathesis. - Have clinical findings that are, in the judgment of the investigator, associated with an increased risk of bleeding. - Have history of ischemic or hemorrhagic stroke, transient ischemic attack (TIA) or intracranial neoplasm, arteriovenous malformation, or aneurysm. - Have an International Normalized Ratio (INR) known to be >1.5 within 1 week of study entry. - Have a known platelet count of <100,000/mm3 within 1 week of study entry. - Have known anemia (hemoglobin [Hgb] <10 gm/dL) within 1 week of study entry. - Are receiving or will receive oral anticoagulation or other antiplatelet therapy (other than ASA) that cannot be safely discontinued for the duration of the trial. - Are receiving daily treatment with non-steroidal anti-inflammatory drugs (NSAIDS) that cannot be discontinued. - Have a concomitant medical illness that in the opinion of the investigator may interfere with or prevent completion in this study. - Have known severe hepatic dysfunction (e.g., cirrhosis or portal hypertension). - Have a history of intolerance or allergy to ASA or approved thienopyridines (ticlopidine or clopidogrel).
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Type-2 Diabetes Mellitus
Coronary Artery Disease
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Ticagrelor + AspirinSingle loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily).
Drug:Clopidogrel + AspirinSingle loading doses of Clopidogrel (600 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (clopidogrel 75 mg + ASA 81 mg once daily).
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Ticagrelor + AspirinLoading-dose plus daily-dosing for 5-7 days.
Clopidogrel + AspirinLoading-dose plus daily-dosing for 5-7 days.
Start Date: July 2013
Completed Date: May 10, 2016
Phase: Phase 4
Primary Outcome: Thrombus Formation
Secondary Outcome: Platelet Reactivity
Study sponsors, principal investigator, and references
Principal Investigator: Juan J Badimon, PhD
Lead Sponsor: Juan J Badimon