Thalidomide fOr the Prevention of Restenosis After Coronary ArtERy Stent Implantation (TOP RACER)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Thalidomide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary restenosis
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Thalidomide
Placebo
Arm Description
Thalidomide
Placebo
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Major adverse cardiac events 6 months after PCI
6-month incidence of major adverse cardiac events (MACE-death, myocardial infarction, target vessel revascularization)
Full Information
NCT ID
NCT01638078
First Posted
July 6, 2012
Last Updated
March 6, 2013
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT01638078
Brief Title
Thalidomide fOr the Prevention of Restenosis After Coronary ArtERy Stent Implantation
Acronym
TOP RACER
Official Title
Thalidomide fOr the Prevention of Restenosis After Coronary ArtERy Stent Implantation - The TOP RACER Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary restenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thalidomide
Arm Type
Active Comparator
Arm Description
Thalidomide
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Other Intervention Name(s)
Thalidomide Celgene
Intervention Description
Thalidomide, pill, 50 mg, once p.d., 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, pill, once p.d., 6 weeks
Primary Outcome Measure Information:
Title
Occurrence of binary restenosis 6 months after PCI
Description
6-month angiographic evidence of binary restenosis (defined as an in-stent stenosis _50% at follow-up coronary angiography)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Major adverse cardiac events 6 months after PCI
Description
6-month incidence of major adverse cardiac events (MACE-death, myocardial infarction, target vessel revascularization)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Pelliccia, MD
Phone
+39064997
Ext
123
Email
f.pelliccia@mclink.it
12. IPD Sharing Statement
Learn more about this trial
Thalidomide fOr the Prevention of Restenosis After Coronary ArtERy Stent Implantation
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