Coronary Artery Disease
Conditions
Keywords
coronary restenosis
Brief 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.
Detailed description
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.
Interventions
DRUGThalidomide
Thalidomide, pill, 50 mg, once p.d., 6 weeks
DRUGPlacebo
Placebo, pill, once p.d., 6 weeks
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A de novo native coronary artery lesions (reference vessel diameter:2.5-3.75 mm) * Class I indication to elective percutaneous coronary intervention * Stable conditions and no recent acute coronary syndromes * Normal baseline values of markers of myocardial damage (creatine kinase, creatine kinase-MB, myoglobin, and troponin I) * Able to understand and willing to sign the informed CF * Contraindications to DES Use (Clinical history difficult to obtain, Expected poor compliance with DAPT, Non-elective surgery required, Increased risk of bleeding * Allergy to ASA or clopidogrel/prasugrel/ticagrelor, Indication for long-term anticoagulation, Large Vessels, Focal Lesions)
Exclusion criteria
* Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT * Indications to DES Use (Small Vessels, Long Lesions Diabetes, In-Stent Restenosis, Complex lesions)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of binary restenosis 6 months after PCI | 6 months | 6-month angiographic evidence of binary restenosis (defined as an in-stent stenosis \_50% at follow-up coronary angiography) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac events 6 months after PCI | 6 months | 6-month incidence of major adverse cardiac events (MACE-death, myocardial infarction, target vessel revascularization) |
Contacts
Primary ContactFrancesco Pelliccia, MD
Outcome results
None listed