Clinical trial NCT02723981: COMBO-Stent in Patients on Chronic Anticoagulant Therapy (COSTA) COSTA-Bleed and COSTA-Outcome Trials
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Stable Angina
Unstable Angina
STEMI
NSTEMI
Coronary Disease
Keywords: Stent , COMBO Stent, anticoagulation
Lead sponsor: IHF GmbH - Institut für Herzinfarktforschung
Sponsor class: OTHER
Collaborators: name: OrbusNeich
First posted: 2016-03-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 exclusion criteria:

* Vessel diameter \<2 und \> 5mm;
* Target lesion with characteristics that make it unsuitable for stent delivery and deployment;
* Planned use of a stent or another coronary device in the same or another session (target vessel or non-target vessel), precluding a COMBO-only strategy.

Primary outcomes:
measure: Number of patients with bleedings
timeFrame: 6 weeks
measure: Number of patients with safety events
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chemnitz
country: Germany
facility: MVZ am Kuechwald GmbH
city: Essen
country: Germany
facility: Elisabeth Krankenhaus
city: Mainz
country: Germany
facility: Universitaetsmedizin Mainz
city: Mannheim
country: Germany
facility: Theresienkrankenhaus und St. Hedwig GmbH
city: Mannheim
country: Germany
facility: Universitaetsmedizin Mannheim
city: Moenchengladbach
country: Germany
facility: St. Franziskus, Kliniken Maria Hilf GmbH
city: Muehlheim an der Ruhr
country: Germany
facility: Evangelisches Krankenhuas Muehlheim a.d. Ruhr GmbH
city: Speyer
country: Germany
facility: Diakonissen-Stiftungs-Krankenhaus
city: Ulm
country: Germany
facility: Herzklinik Ulm GbR
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar-Klinikum
Study officials:
affiliation: Universitaetsmedizin Mainz
name: Tommasso Gori
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaetsmedizin Mannheim
name: Ibrahim Akin
role: PRINCIPAL_INVESTIGATOR
References: