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
Overview
- Phase
- Phase 4
- Intervention
- COMBO-Stent
- Conditions
- Stable Angina
- Sponsor
- IHF GmbH - Institut für Herzinfarktforschung
- Locations
- 10
- Primary Endpoint
- Number of patients with bleedings
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
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.
Investigators
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:
Arms & Interventions
COMBO-Stent
Implantation of COMBO-Stent and medication with (N)OAC and clopidogrel for 3 months followed by (N)OAC alone
Intervention: COMBO-Stent
COMBO-Stent
Implantation of COMBO-Stent and medication with (N)OAC and clopidogrel for 3 months followed by (N)OAC alone
Intervention: Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran
Any Drug eluting or bare metal stent
Implantation of any drug eluting oder bare metal stent combined with anticoagulant medication according to ESC guidelines
Intervention: Any drug eluting stent oder bare metal sent
Any Drug eluting or bare metal stent
Implantation of any drug eluting oder bare metal stent combined with anticoagulant medication according to ESC guidelines
Intervention: ASA, Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran
Outcomes
Primary Outcomes
Number of patients with bleedings
Time Frame: 6 weeks
any BARC (bleeding academic research consortium) bleeding at 6 weeks - superiority.
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.