Stable AnginaPhase 4COSTANCT02723981
COMBO-Stent in Patients on Chronic Anticoagulant Therapy (COSTA) COSTA-Bleed and COSTA-Outcome Trials
A Phase 4 study testing COMBO-Stent, Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran and Any drug eluting stent oder bare metal sent in people with Stable Angina and Unstable Angina, run by IHF GmbH - Institut für Herzinfarktforschung at 10 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina, Unstable Angina, STEMI
- What is being tested?
- COMBO-Stent, Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran and Any drug eluting stent oder bare metal sent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 10 sitesGermany
- Study dates
- Apr 2016to Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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);
Show all 13Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
MVZ am Kuechwald GmbH
Chemnitz
Elisabeth Krankenhaus
Essen
Universitaetsmedizin Mainz
Mainz
Theresienkrankenhaus und St. Hedwig GmbH
Mannheim
Universitaetsmedizin Mannheim
Mannheim
St. Franziskus, Kliniken Maria Hilf GmbH
Mönchengladbach
Evangelisches Krankenhuas Muehlheim a.d. Ruhr GmbH
Muehlheim An Der Ruhr
Diakonissen-Stiftungs-Krankenhaus
Speyer
Herzklinik Ulm GbR
Ulm
Schwarzwald-Baar-Klinikum
Villingen-Schwenningen
About this study
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
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.
Read the 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.
- Conditions
- Stable Angina, Unstable Angina, STEMI, NSTEMI, Coronary Disease
- Being tested
- COMBO-Stent, Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran, Any drug eluting stent oder bare metal sent, ASA, Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran
- Keywords
- Stent , COMBO Stent, anticoagulation
- Medical subject headings
- Angina, Stable, Angina, Unstable, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMBO-StentDevice
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.
Clopidogrel, Vitamin K Antagonist, Rivaroxaban, DabigatranDrug
Also called Plavix, Marcumar, Xarelto, Pradaxa
Anticoagulant medication after stent Implantation: (N)OAC and clopidogrel for 3 months followed by (N)OAC
Any drug eluting stent oder bare metal sentDevice
Also called Cypher, Taxus, CoStar, Janus, Endeavor, Xience, Promus, Multi Link, Coroflex, Veriflex, Integrity, Driver
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
ASA, Clopidogrel, Vitamin K Antagonist, Rivaroxaban, DabigatranDrug
Also called Anticoagulant medication according to ESC guidelines
A combination of antiplatelet and anticoagulant therapy according to ESC guidelines (2014)
| Study group | Role | What they receive |
|---|---|---|
| COMBO-Stent | Experimental | Implantation of COMBO-Stent and medication with (N)OAC and clopidogrel for 3 months followed by (N)OAC alone Receives: Device: COMBO-Stent; Drug: Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran |
| Any Drug eluting or bare metal stent | Active comparator | Implantation of any drug eluting oder bare metal stent combined with anticoagulant medication according to ESC guidelines Receives: Device: Any drug eluting stent oder bare metal sent; Drug: ASA, Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with bleedings
any BARC (bleeding academic research consortium) bleeding at 6 weeks - superiority.
Measured: 6 weeks
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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Regulatory authority approval for the initial study design could not be obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHF GmbH - Institut für Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Collaborators
- OrbusNeich
- Responsible party
- Sponsor
- Investigators
- Tommasso Gori, Principal investigator, Universitaetsmedizin MainzIbrahim Akin, Principal investigator, Universitaetsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723981
- Sponsor's protocol ID
- COSTA-MPG-001
- Acronym
- COSTA
- Status last verified
- Feb 2017
- First submitted
- 16 Mar 2016
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02723981
- Acronym / sponsor ID
- COSTA / COSTA-MPG-001
- Conditions
- Stable Angina, Unstable Angina, STEMI, NSTEMI, Coronary Disease
- Keywords
- Stent , COMBO Stent, anticoagulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Regulatory authority approval for the initial study design could not be obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IHF GmbH - Institut für HerzinfarktforschungUniversity, hospital or other
- Collaborators
- OrbusNeich
- Study start
- Apr 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COMBO-Stent | Experimental | Device: COMBO-Stent, Drug: Clopidogrel, Vitamin K Antagonist, Rivaroxaban, DabigatranImplantation of COMBO-Stent and medication with (N)OAC and clopidogrel for 3 months followed by (N)OAC alone |
| Any Drug eluting or bare metal stent | Active comparator | Device: Any drug eluting stent oder bare metal sent, Drug: ASA, Clopidogrel, Vitamin K Antagonist, Rivaroxaban, DabigatranImplantation of any drug eluting oder bare metal stent combined with anticoagulant medication according to ESC guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COMBO-StentThe 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. | Device | COMBO-Stent |
| Clopidogrel, Vitamin K Antagonist, Rivaroxaban, DabigatranAlso: Plavix, Marcumar, Xarelto, PradaxaAnticoagulant medication after stent Implantation: (N)OAC and clopidogrel for 3 months followed by (N)OAC | Drug | COMBO-Stent |
| Any drug eluting stent oder bare metal sentAlso: Cypher, Taxus, CoStar, Janus, Endeavor, Xience, Promus, Multi Link, Coroflex, Veriflex, Integrity, DriverImplantation 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 | Device | Any Drug eluting or bare metal stent |
| ASA, Clopidogrel, Vitamin K Antagonist, Rivaroxaban, DabigatranAlso: Anticoagulant medication according to ESC guidelinesA combination of antiplatelet and anticoagulant therapy according to ESC guidelines (2014) | Drug | Any Drug eluting or bare metal stent |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tommasso Gori principal investigator
Universitaetsmedizin Mainz
Ibrahim Akin principal investigator
Universitaetsmedizin Mannheim
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing COMBO-Stent, Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran and Any drug eluting stent oder bare metal sent in people with Stable Angina and Unstable Angina, run by IHF GmbH - Institut für Herzinfarktforschung at 10 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with bleedings (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2017.