NCT02723981

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

Prospective, Multi-centre, Randomized, Parallel Comparison to Evaluate the Safety and Efficacy of the Abluminal Sirolimus Coated Bio-engineered Stent (COMBO Stent) in Association With Short-term Single Antiplatelet Therapy in Patients With Coronary Artery Disease With an Indication for Chronic Oral Anticoagulant Therapy as Compared to a Guidelines-based Strategy

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: IHF GmbH - Institut für Herzinfarktforschung · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The COSTA trials are investigator-initiated studies aimed at comparing the clinical outcome after percutaneous coronary intervention (PCI) using a COMBO-stent based strategy associated with short-term antiplatelet therapy with a guidelines-based therapy in patients with an indication for chronic oral anticoagulation. The study is organized as a national, multi-centre prospective, randomized trial. The duration of the follow-up is 15 months.

Conditions

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-05-01
• Completion: 2018-12-01
• First posted: 2016-03-31
• Last updated: 2017-02-20

Locations

10 sites across 1 country: Germany