Thalidomide fOr the Prevention of Restenosis After Coronary ArtERy Stent Implantation

NCT01638078 | Unknown Phase 4 DMC

• 1 other identifier: 429/2012/D
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Keywords

coronary restenosis

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months

Secondary Outcomes (1)

• Major adverse cardiac events 6 months after PCI

  6 months

Study Arms (2)

Thalidomide

ACTIVE COMPARATOR

Thalidomide

Drug: Thalidomide

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Thalidomide DRUG

Thalidomide, pill, 50 mg, once p.d., 6 weeks

Also known as: Thalidomide Celgene

Thalidomide

Placebo DRUG

Placebo, pill, once p.d., 6 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Roma La Sapienza: lead

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Restenosis

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Stenosis

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Francesco Pelliccia, MD

CONTACT

+39064997; f.pelliccia@mclink.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 11, 2012
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2017
• Last Updated: March 7, 2013

Record last verified: 2013-03