Thalidomide fOr the Prevention of Restenosis After Coronary ArtERy Stent Implantation (TOP RACER)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01638078
First received: July 6, 2012
Last updated: March 6, 2013
Last verified: March 2013

July 6, 2012
March 6, 2013
January 2014
June 2015   (final data collection date for primary outcome measure)
Occurrence of binary restenosis 6 months after PCI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
6-month angiographic evidence of binary restenosis (defined as an in-stent stenosis _50% at follow-up coronary angiography)
Same as current
Complete list of historical versions of study NCT01638078 on ClinicalTrials.gov Archive Site
Major adverse cardiac events 6 months after PCI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
6-month incidence of major adverse cardiac events (MACE—death, myocardial infarction, target vessel revascularization)
Same as current
Not Provided
Not Provided
 
Thalidomide fOr the Prevention of Restenosis After Coronary ArtERy Stent Implantation
Thalidomide fOr the Prevention of Restenosis After Coronary ArtERy Stent Implantation - The TOP RACER Trial

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Coronary Artery Disease
  • Drug: Thalidomide
    Thalidomide, pill, 50 mg, once p.d., 6 weeks
    Other Name: Thalidomide Celgene
  • Drug: Placebo
    Placebo, pill, once p.d., 6 weeks
    Other Name: Placebo
  • Active Comparator: Thalidomide
    Thalidomide
    Intervention: Drug: Thalidomide
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
December 2017
June 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Francesco Pelliccia, MD +39064997 ext 123 f.pelliccia@mclink.it
Not Provided
 
NCT01638078
429/2012/D
Yes
Francesco Pelliccia, University of Roma La Sapienza
University of Roma La Sapienza
Not Provided
Not Provided
University of Roma La Sapienza
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP