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

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ClinicalTrials.gov Identifier: NCT02723981
Recruitment Status : Withdrawn (Regulatory authority approval for the initial study design could not be obtained)
First Posted : March 31, 2016
Last Update Posted : February 20, 2017
Sponsor:
Collaborator:
OrbusNeich
Information provided by (Responsible Party):
IHF GmbH - Institut für Herzinfarktforschung

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.

Condition or disease Intervention/treatment Phase
Stable Angina Unstable Angina STEMI NSTEMI Coronary Disease Device: COMBO-Stent Drug: Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran Device: Any drug eluting stent oder bare metal sent Drug: ASA, Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: COMBO-Stent
Implantation of COMBO-Stent and medication with (N)OAC and clopidogrel for 3 months followed by (N)OAC alone
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
Other Name: Plavix, Marcumar, Xarelto, Pradaxa

Active Comparator: Any Drug eluting or bare metal stent
Implantation of any drug eluting oder bare metal stent combined with anticoagulant medication according to ESC guidelines
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
Other Name: Cypher, Taxus, CoStar, Janus, Endeavor, Xience, Promus, Multi Link, Coroflex, Veriflex, Integrity, Driver

Drug: ASA, Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran
A combination of antiplatelet and anticoagulant therapy according to ESC guidelines (2014)
Other Name: Anticoagulant medication according to ESC guidelines




Primary Outcome Measures :
  1. Number of patients with bleedings [ Time Frame: 6 weeks ]
    any BARC (bleeding academic research consortium) bleeding at 6 weeks - superiority.

  2. Number of patients with safety events [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723981


Locations
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Germany
MVZ am Kuechwald GmbH
Chemnitz, Germany
Elisabeth Krankenhaus
Essen, Germany
Universitaetsmedizin Mainz
Mainz, Germany
Theresienkrankenhaus und St. Hedwig GmbH
Mannheim, Germany
Universitaetsmedizin Mannheim
Mannheim, Germany
St. Franziskus, Kliniken Maria Hilf GmbH
Moenchengladbach, Germany
Evangelisches Krankenhuas Muehlheim a.d. Ruhr GmbH
Muehlheim an der Ruhr, Germany
Diakonissen-Stiftungs-Krankenhaus
Speyer, Germany
Herzklinik Ulm GbR
Ulm, Germany
Schwarzwald-Baar-Klinikum
Villingen-Schwenningen, Germany
Sponsors and Collaborators
IHF GmbH - Institut für Herzinfarktforschung
OrbusNeich
Investigators
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Principal Investigator: Tommasso Gori Universitaetsmedizin Mainz
Principal Investigator: Ibrahim Akin Universitaetsmedizin Mannheim

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Responsible Party: IHF GmbH - Institut für Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT02723981     History of Changes
Other Study ID Numbers: COSTA-MPG-001
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by IHF GmbH - Institut für Herzinfarktforschung:
Stent , COMBO Stent, anticoagulation

Additional relevant MeSH terms:
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Angina Pectoris
Coronary Disease
Coronary Artery Disease
Angina, Stable
Angina, Unstable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Vitamins
Vitamin K
Sirolimus
Rivaroxaban
Dabigatran
Clopidogrel
Anticoagulants
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists