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Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor - Optimize Trial

NCT01113372 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3119

Last updated 2015-12-18

No results posted yet for this study

Summary

Prospective, multicenter, randomized (two-arm 1:1), non-inferiority clinical evaluation comparing 2 regimes of dual antiplatelet therapy (DAPT) with aspirin + clopidogrel following percutaneous coronary intervention (PCI) with Endeavor Zotarolimus eluting stent (ZES) to evaluate the impact of different regimes of DAPT on clinical outcomes in minimally selected patients from the "real-world" clinical practice receiving the Endeavor ZES for the treatment of coronary artery lesions. Patients undergoing percutaneous treatment with the Endeavor ZES will be randomized in a 1:1 ratio to 2 regimens of DAPT including oral clopidogrel 75mg/day for 3 months versus 12 months.

Conditions

Interventions

DRUG

Clopidogrel

Clopidogrel 75mg daily.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Cardiovascular Research Center, Brazil

    lead OTHER

Principal Investigators

  • Fausto Feres, PhD · Instituto Dante Pazzanese de Cardiologia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-02-28
Completion
2015-07-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01113372 on ClinicalTrials.gov