Synergy Between Stent and Drugs to Avoid Ischemic Recurrences After Percutaneous Coronary Intervention

NCT00611286 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1700

Last updated 2012-10-10

No results posted yet for this study

Summary

The duration of dual antiplatelet treatment (i.e. asprin and clopidogrel) after drug-eluting stent implantation is highly debated. This study will evaluate the value of extending such treatment up to 2 years after the procedure as compared to conventional treatment according to our national health institute guidelines (i.e. minimum 1 month after bare metal stent and 6 months after drug-eluting stent) on the composite endpoint of death, MI or stroke.

Conditions

Interventions

DRUG

clopidogrel treatment after bare metal stent implantation

extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of bare metal stent

DRUG

clopidogrel treatment after bare metal stent implantation

Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 1 month after BMS implantation.

DRUG

clopidogrel after zotarolimus-eluting stent implantation

extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of zotarolimus-eluting stent coronary implantation

DRUG

clopidogrel after paclitaxel-eluting stent implantation

extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of paclitaxel-eluting stent

DRUG

clopidogrel after everolimus-eluting stent implantation

extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of Everolimus-eluting stent

DRUG

clopidogrel after zotarolimus-eluting stent implantation

Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.

DRUG

clopidogrel after paclitaxel-eluting stent implantation

Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.

DRUG

clopidogrel after everolimus-eluting stent implantation

Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.

Sponsors & Collaborators

  • Marco Valgimigli

    lead OTHER

Principal Investigators

  • Marco Valgimigli, MD, PhD · University of Ferrara, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2010-12-31
Completion
2012-10-31

Countries

  • Italy

Study Locations

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Entities

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 NCT00611286 on ClinicalTrials.gov