drugset / Trial / NCT01638078

Thalidomide fOr the Prevention of Restenosis After Coronary ArtERy Stent Implantation

NCT01638078

Phase 4 Unknown 100 enrolled University of Roma La Sapienza
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Percutaneous coronary intervention (PCI) with the use of bare metal stents is associated with restenosis in approximately 10% to 50% of cases. Stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to restenosis and atherosclerosis within the stented segments. The sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory and antioncogenic properties that could be of benefit in case of PCI with stenting.

Timeline

Start
2014-01
Primary completion
2015-06
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Thalidomide Other / unclassified 50 mg Oral