Coronary Disease Clinical Trial
— COSTAOfficial 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
Verified date | February 2017 |
Source | IHF GmbH - Institut für Herzinfarktforschung |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2018 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 InvestigatorĀ“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. |
Country | Name | City | State |
---|---|---|---|
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 |
Lead Sponsor | Collaborator |
---|---|
IHF GmbH - Institut für Herzinfarktforschung | OrbusNeich |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with bleedings | any BARC (bleeding academic research consortium) bleeding at 6 weeks - superiority. | 6 weeks | |
Primary | Number of patients with safety events | 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. | 15 months |
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