Phase 4
N=20
Ticagrelor Versus Clopidogrel in Type 2 Diabetic Patients
Type-2 Diabetes Mellitus · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01823510 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Thrombus Formation — 66.9; 84.4; 59.9; 79.8 percentage of baseline size
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ticagrelor + Aspirin (Drug); Clopidogrel + Aspirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Juan J Badimon
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Thrombus Formation |
66.9; 84.4; 59.9; 79.8; 68.9; 82.6 | — |
| SECONDARY Platelet Reactivity |
20.5; 54.5; 20.6; 43.6; 24.2; 45.5 | — |
| SECONDARY P2Y12 Reaction Unit (PRU) |
14.8; 77.8; 8.2; 66.8; 14.5; 62.7 | — |
| SECONDARY Platelet Reactivity Index (PRI) |
21.8; 85.8; 17.8; 82.5; 17.2; 68.4 | — |
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 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.
Eligibility Criteria
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 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).
Data sourced from ClinicalTrials.gov (NCT01823510). 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.