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COMBO-Stent in Patients on Chronic Anticoagulant Therapy (COSTA) COSTA-Bleed and COSTA-Outcome Trials

NCT02723981 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-02-20

No results posted yet for this study

Summary

Prospective, multi-centre, randomized, open-label, parallel comparisons to evaluate

* the incidence of bleedings (COSTA-Bleed) and
* the incidence of ischemic and bleeding events (COSTA-Outcome) following a therapy with the abluminal sirolimus coated bio-engineered stent (COMBO stent) in association with short-term single antiplatelet therapy as compared to a guidelines-based strategy in patients with coronary artery disease with an indication for chronic oral anticoagulant therapy.

Conditions

  • Stable Angina
  • Unstable Angina
  • STEMI
  • NSTEMI
  • Coronary Disease

Interventions

DEVICE

COMBO-Stent

The OrbusNeich COMBO Bio-engineered Sirolimus Eluting Stent (COMBO Stent) consists of a 316L stainless steel alloy abluminally coated with a biocompatible, biodegradable poly-mer containing sirolimus. Covalently attached to the surface of the stent is a layer of murine, monoclonal, anti-human CD34 antibody. The antibody specifically targets circulatory CD34+ cells (endothelial progenitor cells) thus favoring endothelialization.

DRUG

Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran

Anticoagulant medication after stent Implantation: (N)OAC and clopidogrel for 3 months followed by (N)OAC

DEVICE

Any drug eluting stent oder bare metal sent

Implantation of traditional bare metal stents and/or drug eluting stents (any device approved on the market, implanted according to CE marking and IFU) and medication regimen in accordance with ESC Guidelines

DRUG

ASA, Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran

A combination of antiplatelet and anticoagulant therapy according to ESC guidelines (2014)

Sponsors & Collaborators

  • OrbusNeich

    collaborator INDUSTRY

  • IHF GmbH - Institut für Herzinfarktforschung

    lead OTHER

Principal Investigators

  • Tommasso Gori · Universitaetsmedizin Mainz

  • Ibrahim Akin · Universitaetsmedizin Mannheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-05-31
Completion
2018-12-31

Countries

  • Germany

Study Locations

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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 NCT02723981 on ClinicalTrials.gov