AnticoagulantsPhase 4WOESTNCT00769938
WOEST ( What is the Optimal antiplatElet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary StenTing)
A Phase 4 study testing PCI (percutaneous coronary intervention) in people with Anticoagulants and Platelet Aggregation Inhibitors, run by R&D Cardiologie at 15 sites in 2 countries.
Trial summary
The study will assess the hypothesis that the combination warfarin \& clopidogrel 75 mg/day is superior to triple therapy (warfarin + clopidogrel 75mg/day + aspirin 80mg/day) with respect to bleeding complications while equally safe with respect to the prevention of thrombotic complications in patients with both… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anticoagulants, Platelet Aggregation Inhibitors, Stents
- What is being tested?
- PCI (percutaneous coronary intervention)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 573 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Dec 2008to Aug 2012
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients is on oral anticoagulation therapy and this will be continued throughout the period of 1 year-and deployment of at least 1 coronary stent (bare metal stent (BMS) or drug eluting stent (DES)). -age of more than 18 years
Who cannot join
- cardiogenic shock,
- contra-indication for aspirin or clopidogrel
- allergy to aspirin or clopidogrel,
- documented peptic ulcer disease within the previous six months,
- pregnancy and
- previous intracerebral haemorrhage or
Show all 9Show fewer
- significant thrombocytopenia (platelet count < 50x10 9/L).
- major bleeding according to timi criteria within the past 12 months
- age > 80 years
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Netherlands10 sites
MCA Alkmaar
Alkmaar
Academisch Medisch Centrum Amsterdam
Amsterdam
OLVG
Amsterdam
Amphia Ziekenhuis
Breda
Catharina Ziekenhuis
Eindhoven
UMCG
Groningen
Sint Antonius Ziekenhuis
Nieuwegein, 3435 CM
Zuiderziekenhuis
Rotterdam
Twee Steden Ziekenhuis
Tlibrug
Isala klinieken
Zwolle
Belgium5 sites
OLV Aalst
Aalst
UZ Antwerpen
Antwerp
ZOL
Genk
Maria Middelares
Ghent
UZ KU Leuven
Leuven, Leuven
About this study
Official title: What is the Optimal antiplatElet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary StenTing
The study will assess the hypothesis that the combination warfarin \& clopidogrel 75 mg/day is superior to triple therapy (warfarin + clopidogrel 75mg/day + aspirin 80mg/day) with respect to bleeding complications while equally safe with respect to the prevention of thrombotic complications in patients with both indications for warfarin use and dual antiplatelet (clopidogrel 75mg/day + aspirin 80mg/day) treatment.
Read the detailed description
Chronic oral antithrombotic treatment is necessary in patients with mechanical heart valves and in the majority of patients with atrial fibrillation. When these patients have to undergo Percutaneous Coronary Intervention (PCI) with stenting, there is also an indication for treatment with aspirin and clopidogrel. However, triple therapy is known to augment the risk for bleeding complications.Unfortunately, no prospective data are available to solve this issue. Nevertheless, it all comes down to finding the ideal therapy in patients with both atrial fibrillation and percutaneous intervention to prevent thrombotic complications (e.g. stent thrombosis) without increasing the risk of bleeding. This prospective randomised study will assess the hypothesis that in patients on warfarin therapy and indication for elective percutaneous intervention, the combination warfarin \& clopidogrel 75 mg/day is superior to triple therapy treatment in reducing the risk of bleeds while equally safe with respect to the prevention of thrombotic complications
- Being tested
- PCI (percutaneous coronary intervention)
- Keywords
- Atrial fibrillation, Percutaneous coronary stenting, Bleeding complications, Triple therapy
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI (percutaneous coronary intervention)Device
only patients scheduled for PCI can be included tough this intervention would also take place without this study. What we want to study is the difference in outcome after a little change in the antithrombotic treatment
| Study group | Role | What they receive |
|---|---|---|
| Aspirin + clopidogrel + oral anticoagulation | Active comparator | Not described Receives: Device: PCI (percutaneous coronary intervention) |
| Oral anticoagulants + clopidogrel | Active comparator | Not described Receives: Device: PCI (percutaneous coronary intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The combined end point of minor, moderate or major bleeding complications during the initial hospitalization & one year follow-up. (TIMI & GUSTO criteria).
Measured: 1 year
Secondary outcomes (1)
The combined event of death, myocardial infarction, stroke, systemic embolization & target vessel revascularisation and the individual components of the composite primary and secondary endpoints.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnticoagulantsStudies 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
- 573 participants (actual)
Sponsor and investigators
- Lead sponsor
- R&D Cardiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, W. Dewilde, R&D Cardiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769938
- Sponsor's protocol ID
- RDC-2008-03
- Acronym
- WOEST
- Status last verified
- Jan 2013
- First submitted
- 8 Oct 2008
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dewilde WJ, Janssen PW, Kelder JC, Verheugt FW, De Smet BJ, Adriaenssens T, Vrolix M, Brueren GB, Van Mieghem C, Cornelis K, Vos J, Breet NJ, ten Berg JM. Uninterrupted oral anticoagulation versus bridging in patients with long-term oral anticoagulation during percutaneous coronary intervention: subgroup analysis from the WOEST trial. EuroIntervention. 2015 Aug;11(4):381-90. doi: 10.4244/EIJY14M06_07.
PubMed 24970794Dewilde WJ, Oirbans T, Verheugt FW, Kelder JC, De Smet BJ, Herrman JP, Adriaenssens T, Vrolix M, Heestermans AA, Vis MM, Tijsen JG, van 't Hof AW, ten Berg JM; WOEST study investigators. Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial. Lancet. 2013 Mar 30;381(9872):1107-15. doi: 10.1016/S0140-6736(12)62177-1. Epub 2013 Feb 13.
PubMed 23415013Dewilde W, Berg JT. Design and rationale of the WOEST trial: What is the Optimal antiplatElet and anticoagulant therapy in patients with oral anticoagulation and coronary StenTing (WOEST). Am Heart J. 2009 Nov;158(5):713-8. doi: 10.1016/j.ahj.2009.09.001.
PubMed 19853687
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Optimal antiplatElet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary StenTing
- ClinicalTrials.gov ID
- NCT00769938
- Acronym / sponsor ID
- WOEST / RDC-2008-03
- Keywords
- Atrial fibrillation, Percutaneous coronary stenting, Bleeding complications, Triple therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 573 participants (actual)
- Lead sponsor
- R&D CardiologieUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Oct 2008 (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.
The study will assess the hypothesis that the combination warfarin \& clopidogrel 75 mg/day is superior to triple therapy (warfarin + clopidogrel 75mg/day + aspirin 80mg/day) with respect to bleeding complications while equally safe with respect to the prevention of thrombotic complications in patients with both indications for warfarin use and dual antiplatelet (clopidogrel 75mg/day + aspirin 80mg/day) treatment.
Detailed description
Chronic oral antithrombotic treatment is necessary in patients with mechanical heart valves and in the majority of patients with atrial fibrillation. When these patients have to undergo Percutaneous Coronary Intervention (PCI) with stenting, there is also an indication for treatment with aspirin and clopidogrel. However, triple therapy is known to augment the risk for bleeding complications.Unfortunately, no prospective data are available to solve this issue. Nevertheless, it all comes down to finding the ideal therapy in patients with both atrial fibrillation and percutaneous intervention to prevent thrombotic complications (e.g. stent thrombosis) without increasing the risk of bleeding. This prospective randomised study will assess the hypothesis that in patients on warfarin therapy and indication for elective percutaneous intervention, the combination warfarin \& clopidogrel 75 mg/day is superior to triple therapy treatment in reducing the risk of bleeds while equally safe with respect to the prevention of thrombotic complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin + clopidogrel + oral anticoagulation | Active comparator | Device: PCI (percutaneous coronary intervention) |
| Oral anticoagulants + clopidogrel | Active comparator | Device: PCI (percutaneous coronary intervention) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients is on oral anticoagulation therapy and this will be continued throughout the period of 1 year-and deployment of at least 1 coronary stent (bare metal stent (BMS) or drug eluting stent (DES)). -age of more than 18 years
Key exclusion criteria (9 listed)
- cardiogenic shock,
- contra-indication for aspirin or clopidogrel
- allergy to aspirin or clopidogrel,
- documented peptic ulcer disease within the previous six months,
- pregnancy and
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 |
|---|---|---|
| PCI (percutaneous coronary intervention)only patients scheduled for PCI can be included tough this intervention would also take place without this study. What we want to study is the difference in outcome after a little change in the antithrombotic treatment | Device | Aspirin + clopidogrel + oral anticoagulation, Oral anticoagulants + clopidogrel |
Primary outcome
The combined end point of minor, moderate or major bleeding complications during the initial hospitalization & one year follow-up. (TIMI & GUSTO criteria).
Time frame: 1 year
1 secondary outcome
The combined event of death, myocardial infarction, stroke, systemic embolization & target vessel revascularisation and the individual components of the composite primary and secondary endpoints.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
- Derived from this study: PubMed 24970794Dewilde WJ, Janssen PW, Kelder JC, Verheugt FW, De Smet BJ, Adriaenssens T, Vrolix M, Brueren GB, Van Mieghem C, Cornelis K, Vos J, Breet NJ, ten Berg JM. Uninterrupted oral anticoagulation versus bridging in patients with long-term oral anticoagulation during percutaneous coronary intervention: subgroup analysis from the WOEST trial. EuroIntervention. 2015 Aug;11(4):381-90. doi: 10.4244/EIJY14M06_07.
- Derived from this study: PubMed 23415013Dewilde WJ, Oirbans T, Verheugt FW, Kelder JC, De Smet BJ, Herrman JP, Adriaenssens T, Vrolix M, Heestermans AA, Vis MM, Tijsen JG, van 't Hof AW, ten Berg JM; WOEST study investigators. Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial. Lancet. 2013 Mar 30;381(9872):1107-15. doi: 10.1016/S0140-6736(12)62177-1. Epub 2013 Feb 13.
- Derived from this study: PubMed 19853687Dewilde W, Berg JT. Design and rationale of the WOEST trial: What is the Optimal antiplatElet and anticoagulant therapy in patients with oral anticoagulation and coronary StenTing (WOEST). Am Heart J. 2009 Nov;158(5):713-8. doi: 10.1016/j.ahj.2009.09.001.
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PCI (percutaneous coronary intervention) in people with Anticoagulants and Platelet Aggregation Inhibitors, run by R&D Cardiologie at 15 sites in 2 countries.
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 1 inclusion and 9 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: finished, as of the sponsor's last update on 15 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Netherlands, Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The combined end point of minor, moderate or major bleeding complications during the initial hospitalization & one year follow-up. (TIMI & GUSTO criteria). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00769938, which also lists 3 linked publications.
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 15 Jan 2013.