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The Effects of Bindarit in Preventing Stent Restenosis

NCT01269242 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2016-08-05

No results posted yet for this study

Summary

The main study objective is to assess the efficacy and safety of different bindarit dosages compared to placebo in preventing restenosis, in patients submitted to coronary stenting and using a bare metal stent (Vision BMS, by Abbott).

Conditions

  • Coronary Restenosis

Interventions

DRUG

bindarit

300 mg bid, that is one 300 mg tablet twice a day for 6 months;

DRUG

bindarit

600 mg bid, that is two 300 mg tablets twice a day for 6 months

DRUG

placebo

bindarit-matching placebo tablets for 6 months.

Sponsors & Collaborators

  • Aziende Chimiche Riunite Angelini Francesco S.p.A

    lead INDUSTRY

Principal Investigators

  • Antonio Colombo, MD · Fondazione S.Raffaele del Monte Tabor - U.O Emodinamica e Cardiologia Interventistica

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-01-31
Completion
2011-04-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01269242 on ClinicalTrials.gov