Status:
COMPLETED
Ticagrelor Versus Clopidogrel in Type 2 Diabetic Patients
Lead Sponsor:
Juan J Badimon
Collaborating Sponsors:
AstraZeneca
Conditions:
Type-2 Diabetes Mellitus
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
The rising prevalence of diabetes mellitus and its associated cardiovascular complications present a major burden to healthcare providers worldwide. Cardiovascular mortality is much higher among subje...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01823510
Start Date
July 1 2013
End Date
May 10 2016
Last Update
December 8 2017
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029