drugset / Trial / NCT02091921

Switch to Ticagrelor in Critical Limb Ischemia Anti-platelet Study

NCT02091921

Phase 1/2 Completed 53 enrolled University of Southern California
NaSingle-groupOpen-labelScreening

Summary

Critical Limb Ischemia (CLI) is defined as limb pain that occurs at rest, or impending limb loss that is caused by severe compromise of blood flow to the affected extremity. CLI is a major cause of death and disability (secondary to myocardial infarction, stroke and amputation). The mortality in patients with CLI approaches 13-25% and 50% at one and five years respectively. High on-treatment platelet reactivity (HPR) in patients treated with aspirin and clopidogrel is associated with increased risk of recurrent cardiovascular events after percutaneous coronary interventions and coronary syndromes. Preliminary studies suggest that the prevalence of HPR in patients with critical limb ischemia treated with aspirin and clopidogrel is as high a 78.5%. In patients with coronary artery disease ticagrelor overcomes non-responsiveness to clopidogrel. However, the antiplatelet effect of ticagrelor in patients with critical limb ischemia is unknown.

Timeline

Start
2014-02-16
Primary completion
2016-11-30
Completion
2016-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ticagrelor Small molecule 90 mg

Indications