WOEST ( What is the Optimal antiplatElet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary StenTing) (WOEST)
Primary Purpose
Anticoagulants, Platelet Aggregation Inhibitors, Stents
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
PCI (percutaneous coronary intervention)
Sponsored by
About this trial
This is an interventional treatment trial for Anticoagulants focused on measuring Atrial fibrillation, Percutaneous coronary stenting, Bleeding complications, Triple therapy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- significant thrombocytopenia (platelet count < 50x10 9/L).
- major bleeding according to timi criteria within the past 12 months
- age > 80 years
Sites / Locations
- OLV Aalst
- UZ Antwerpen
- ZOL
- Maria Middelares
- UZ KU Leuven
- MCA Alkmaar
- Academisch Medisch Centrum Amsterdam
- OLVG
- Amphia Ziekenhuis
- Catharina Ziekenhuis
- UMCG
- Sint Antonius Ziekenhuis
- Zuiderziekenhuis
- Twee Steden Ziekenhuis
- Isala klinieken
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Aspirin + clopidogrel + oral anticoagulation
Oral anticoagulants + clopidogrel
Arm Description
Outcomes
Primary Outcome Measures
The combined end point of minor, moderate or major bleeding complications during the initial hospitalization & one year follow-up. (TIMI & GUSTO criteria).
Secondary Outcome Measures
The combined event of death, myocardial infarction, stroke, systemic embolization & target vessel revascularisation and the individual components of the composite primary and secondary endpoints.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00769938
Brief Title
WOEST ( What is the Optimal antiplatElet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary StenTing)
Acronym
WOEST
Official Title
What is the Optimal antiplatElet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary StenTing
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
R&D Cardiologie
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anticoagulants, Platelet Aggregation Inhibitors, Stents, Atrial Fibrillation
Keywords
Atrial fibrillation, Percutaneous coronary stenting, Bleeding complications, Triple therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
573 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aspirin + clopidogrel + oral anticoagulation
Arm Type
Active Comparator
Arm Title
Oral anticoagulants + clopidogrel
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
PCI (percutaneous coronary intervention)
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
significant thrombocytopenia (platelet count < 50x10 9/L).
major bleeding according to timi criteria within the past 12 months
age > 80 years
Facility Information:
Facility Name
OLV Aalst
City
Aalst
Country
Belgium
Facility Name
UZ Antwerpen
City
Antwerpen
Country
Belgium
Facility Name
ZOL
City
Genk
Country
Belgium
Facility Name
Maria Middelares
City
Gent
Country
Belgium
Facility Name
UZ KU Leuven
City
Leuven
Country
Belgium
Facility Name
MCA Alkmaar
City
ALkmaar
Country
Netherlands
Facility Name
Academisch Medisch Centrum Amsterdam
City
Amsterdam
Country
Netherlands
Facility Name
OLVG
City
Amsterdam
Country
Netherlands
Facility Name
Amphia Ziekenhuis
City
Breda
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
UMCG
City
Groningen
Country
Netherlands
Facility Name
Sint Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Zuiderziekenhuis
City
Rotterdam
Country
Netherlands
Facility Name
Twee Steden Ziekenhuis
City
Tlibrug
Country
Netherlands
Facility Name
Isala klinieken
City
Zwolle
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
24970794
Citation
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.
Results Reference
derived
PubMed Identifier
23415013
Citation
Dewilde 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.
Results Reference
derived
PubMed Identifier
19853687
Citation
Dewilde 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.
Results Reference
derived
Learn more about this trial
WOEST ( What is the Optimal antiplatElet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary StenTing)
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