A Phase 4 interventional study of Thalidomide and Placebo in Coronary Artery Disease, sponsored by University of Roma La Sapienza. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-07.
Sponsored by University of Roma La Sapienza · Phase 4, Interventional, and Treatment
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.
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.
Indeed, experimental studies indicate a marked activation of inflammatory cells at the site of stent struts, which is likely to play a key role in the process of neointimal proliferation and restenosis. Indeed, tumor necrosis factor and interleukins 1 and 6 are powerful stimuli for smooth muscle cell proliferation.
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.
The primary objective of this study is to carry out a double-blind, randomized, placebo-controlled study to assess the effects of oral thalidomide on restenosis rate after successful stent implantation.
5,598 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's planned enrollment of 100 is below the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Thalidomide
Drug: Thalidomide
Placebo
Drug: Placebo
Thalidomide, pill, 50 mg, once p.d., 6 weeks
Also known as: Thalidomide Celgene
Placebo, pill, once p.d., 6 weeks
Occurrence of binary restenosis 6 months after PCI
6-month angiographic evidence of binary restenosis (defined as an in-stent stenosis _50% at follow-up coronary angiography)
Time frame: 6 months
Major adverse cardiac events 6 months after PCI
6-month incidence of major adverse cardiac events (MACE-death, myocardial infarction, target vessel revascularization)
Time frame: 6 months
No study locations are listed for this record.
This study is status unknown, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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University of Roma La Sapienza