Coronary Disease, NSTEMI, Stable Angina, STEMI, Unstable Angina
Conditions
Keywords
Stent , COMBO Stent, anticoagulation
Brief 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.
Interventions
DEVICECOMBO-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.
DRUGClopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran
Anticoagulant medication after stent Implantation: (N)OAC and clopidogrel for 3 months followed by (N)OAC
DEVICEAny 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
DRUGASA, Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran
A combination of antiplatelet and anticoagulant therapy according to ESC guidelines (2014)
Sponsors
OrbusNeich
IHF GmbH - Institut für Herzinfarktforschung
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 and older; * Willingness to comply with the study protocol; subject or a legally authorized representative must provide written informed consent prior to any study related procedure, in accordance with International Conference on harmonization of Good Clinical Practice (ICH-GCP) guidelines and per site requirements. * Patients on anticoagulant therapy or treatment-naive pa-tients with an indication to chronic anticoagulant therapy. Indications to oral anticoagulation may include atrial fibrillation, prosthetic valve disease, peripheral by-pass surgery, lung embolism or deep vein thrombosis or any other indication according to the Investigator´s opinion. * Single or multiple de novo lesion in a native coronary artery, all amenable to treatment with the COMBO stent;
Exclusion criteria
* Patients who, in the Investigator's opinion, should not be treated with (N)OAC. These may include, for instance: history of BARC 3-5 bleeding \<12 months; patients with a haemorrhagic disorder or bleeding diathesis (e.g. von Willebrand disease, haemophilia A or B or other hereditary bleeding disorder, history of spontaneous intra-articular bleeding, history of prolonged bleeding after surgery/intervention); patients with recent major surgery; history of intraocular, spinal, retroperitoneal, intra-articular or recent gastrointestinal bleeding unless the causative factor has been permanently eliminated or repaired; (reduction in the haemoglobin level of at least 2g/dL, transfusion of at least two units of blood, or symptomatic bleeding in a critical area or organ) including life-threatening bleeding episode (symptomatic intracranial bleeding, bleeding with a decrease in the haemoglobin level of at least 5g/dL or bleeding requiring transfusion of at least 4 units of blood or inotropic agents or necessitating surgery); Anaemia (haemoglobin \<10g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count \<100E9/L) at screening; * Pregnant or nursing patients. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test; * Other medical illness with a life expectancy \<2 years (e.g. known malignancy) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol or confound the data in-terpretation or is associated with a limited life expectancy; * Patient has received an organ transplant or is on a wait-ing list for an organ transplant; * Known hypersensitivity or contraindication to antiplate-let or anticoagulant agents that does not allow guide-lines-compliant therapy and that cannot be adequately pre-medicated; * Previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies (HAMA); * Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study; * Current participation in another investigational drug or device study except for non-interventional registries; * Patients not willing or able to comply with the protocol requirements or considered unreliable by the Investigator concerning the requirements for follow up during the study and/or compliance with study drug administration; Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with bleedings | 6 weeks | any BARC (bleeding academic research consortium) bleeding at 6 weeks - superiority. |
| Number of patients with safety events | 15 months | Strategy oriented composite safety endpoint, including death (unless proven not to be connected to the other endpoints), any MI, stroke or systemic embolism, definite or probable stent thrombosis, BARC 3-4 bleeding at 15 months post PCI - non-inferiority with reflex to superiority testing. Hierarchical testing: Endpoint II is only tested if null hypothesis of no difference in bleeding incidence can be rejected at final analysis. |
Countries
Germany
Outcome results
None listed