drugset / Trial / NCT02505399

TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement

NCT02505399 ↗

Phase 4 Completed 180 enrolled University Hospital, Toulouse
RandomizedParallel-groupDouble-blindPrevention

Summary

Rotational atherectomy (RA) prior to angioplasty is the reference treatment for highly calcified atherosclerotic coronary lesions. It aims at fragmenting calcium deposits into microscopic particulates to allow less hazardous coronary revascularization and stenting. The main drawback associated with the procedure is the subsequent enhancement of platelet aggregation which promotes the distal embolization of micro-thrombi and atherosclerotic fragments. In order to limit these complications, a double antiplatelet therapy is required (generally Clopidogrel + Aspirin) when RA procedures are performed. Clopidogrel inhibits the protein P2Y12 which is a cornerstone in platelet aggregation. Ticagrelor is a new antiplatelet agent that provides faster and greater P2Y12 inhibition than Clopidogrel. It is currently indicated to reduce risk of cardiovascular events in patients hospitalized for coronary revascularization after an acute coronary syndrome. Ticagrelor has never been evaluated so far in stable coronary patients treated with rotational atherectomy prior to angioplasty.

Timeline

Start
2015-11
Primary completion
2018-05-24
Completion
2018-05-30

Outcome

Missed primary endpoint

paper Troponin release did not differ among treatment arms. PMID 36835980 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clopidogrel Small molecule 75 mg Oral
Subject Ticagrelor Small molecule 90 mg Oral

Indications