- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02247128
Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation (POPular-TAVI)
At present, a variety of antithrombotic regimens are prescribed in the early postprocedure period after transcatheter aortic valve implantation (TAVI). Dual antiplatelet therapy (DAPT) using aspirin and a thienopyridine in the initial period after TAVI is the recommended strategy; however, mono antiplatelet therapy using aspirin is suggested not to be inferior. In patients with atrial fibrillation (AF) or another indication for oral anticoagulation (OAC), no recommendations on best treatment regimen currently exist although triple therapy (OAC + DAPT) is best avoided due to increased bleeding risk.
We hypothesise that the omission of clopidogrel in the first 3 months after TAVI is safer and not less beneficial than the addition of clopidogrel to aspirin (cohort A) or OAC (cohort B).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The trial consists of two cohorts:
- Cohort A, patients without an indication for OAC prior to TAVI.
- Cohort B, patients with an indication for OAC prior to TAVI (eg. atrial fibrillation, mechanic mitral valve prosthesis).
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Aalst, Belgium
- Algemeen Stedelijk Ziekenhuis
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Aalst, Belgium
- Onze Lieve Vrouwe Ziekenhuis
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Bonheiden, Belgium
- Imelda Ziekenhuis
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Brugge, Belgium
- Algemeen Ziekenhuis Sint Jan
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Genk, Belgium
- Ziekenhuis Oost-Limburg
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Leuven, Belgium
- Universitair Ziekenhuis Leuven
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Prague, Czechia
- Charles university, Third Faculty of Medicine
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Luxembourg, Luxembourg
- National Institute Surgery Cardiaque Et De Cardiologie Interventionnelle
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Den Haag, Netherlands
- HAGA ziekenhuis
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Enschede, Netherlands
- Medisch Spectrum Twente
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Groningen, Netherlands, 9700 RB
- University Medical Center
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Leiden, Netherlands
- Universitair Medisch Centrum Leiden
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Maastricht, Netherlands, 6229 HX
- Academic Hospital
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Utrecht, Netherlands, 3584 CX
- University Medical Center Utrecht (UMCU)
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Noord Holland
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Amsterdam, Noord Holland, Netherlands, 1105 AZ
- Academic Medical Centre (AMC)
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Overijssel
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Zwolle, Overijssel, Netherlands, 8011 JW
- Isala Clinics
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Utrecht
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Nieuwegein, Utrecht, Netherlands, 3435CM
- St. Antonius Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Cohort A
1. Patient has provided written informed consent.
Cohort B
- Need for long-term oral anticoagulation;
- Patient has provided written informed consent.
Exclusion Criteria:
Cohort A
- Need for long-term oral anticoagulation;
- Drug-eluting stent implantation within 3 months prior to TAVI procedure;
- Bare-metal stent implantation within 1 month prior to TAVI procedure;
- Allergy or intolerance to aspirin or clopidogrel.
Cohort B
- Drug-eluting stent implantation within 3 months prior to TAVI procedure;
- Bare-metal stent implantation within 1 month prior to TAVI procedure;
- Allergy or intolerance to (N)OAC or clopidogrel.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Aspirin + Clopicogrel (Cohort A)
Cohort A: patients will receive clopidogrel (75mg quaque die (qD), 3 months) on top of low-dose aspirin (≤100mg qD, at least 1 year but recommended lifelong).
When a patient in Cohort A doesn't already takes aspirin, a loading dose of 300mg will be given within 24 hours prior to TAVI.
The loading dose for clopidogrel is 300mg, and will be given within 24 hours prior to TAVI.
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Active Comparator: Aspirin monotherapy (Cohort A)
Cohort A: patients will receive low-dose aspirin (≤100mg qD, at least 1 year but recommended lifelong).
When a patients doesn't already takes aspirin, a loading dose of 300mg will be given within 24 hours prior to TAVI.
It is recommended to omit other antiplatelet therapy (e.g.
clopidogrel) at least 5 days prior to the TAVI procedure.
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Active Comparator: OAC + Clopicogrel (Cohort B)
Cohort B: patients will receive clopidogrel (75mg qD, 3 months) on top of OAC (according to its indication).
The loading dose for clopidogrel is 300mg, and will be given within 24 hours prior to TAVI.
It is recommended to omit other antiplatelet therapy (e.g.
aspirin) at least 5 days prior to the TAVI procedure.
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Active Comparator: OAC monotherapy (Cohort B)
Cohort B: patients will receive OAC according to its indication.
It is recommended to continue the OAC therapy peri-procedural (International Normalized Ratio aimed at 2.0).
It is recommended to omit antiplatelet therapy (e.g.
clopidogrel) at least 5 days prior to the TAVI procedure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety endpoint
Time Frame: 1 year
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The primary outcome is a safety endpoint, defined as freedom of all bleeding complications at 1 year after TAVI.
The co-primary outcome is the safety endpoint defined as freedom of non-procedure related bleeding complications at 1 year after TAVI.
For the classification of bleeding complications the Bleeding Academic Research Consortium Definition for Bleeding (BARC) bleeding classification is primarily used according to the Valve Academic Research Consortium (VARC).
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Net-clinical benefit endpoint
Time Frame: 1 year
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The secondary outcome is a net-clinical benefit endpoint, defined as freedom of the non-hierarchical composite of cardiovascular mortality, non-procedure related bleeding, stroke, or myocardial infarction at 1 year after TAVI.
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1 year
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Efficacy endpoint
Time Frame: 1 year
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The co-secondary outcome is an efficacy endpoint, defined as freedom of the non-hierarchical composite of cardiovascular mortality, ischemic stroke, or myocardial infarction at 1 year after TAVI.
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1 year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacoeconomics endpoint
Time Frame: 1 year
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Outcome measure is quality-adjusted life years
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jurrien M ten Berg, PhD, MD, St. Antonius Hospital
- Principal Investigator: Pieter R Stella, MD, PhD, University Medical Center Utrecht (UMCU)
Publications and helpful links
General Publications
- Brouwer J, Nijenhuis VJ, Delewi R, Hermanides RS, Holvoet W, Dubois CLF, Frambach P, De Bruyne B, van Houwelingen GK, Van Der Heyden JAS, Tousek P, van der Kley F, Buysschaert I, Schotborgh CE, Ferdinande B, van der Harst P, Roosen J, Peper J, Thielen FWF, Veenstra L, Chan Pin Yin DRPP, Swaans MJ, Rensing BJWM, van 't Hof AWJ, Timmers L, Kelder JC, Stella PR, Baan J, Ten Berg JM. Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation. N Engl J Med. 2020 Oct 8;383(15):1447-1457. doi: 10.1056/NEJMoa2017815. Epub 2020 Aug 30.
- Nijenhuis VJ, Brouwer J, Delewi R, Hermanides RS, Holvoet W, Dubois CLF, Frambach P, De Bruyne B, van Houwelingen GK, Van Der Heyden JAS, Tousek P, van der Kley F, Buysschaert I, Schotborgh CE, Ferdinande B, van der Harst P, Roosen J, Peper J, Thielen FWF, Veenstra L, Chan Pin Yin DRPP, Swaans MJ, Rensing BJWM, van 't Hof AWJ, Timmers L, Kelder JC, Stella PR, Baan J, Ten Berg JM. Anticoagulation with or without Clopidogrel after Transcatheter Aortic-Valve Implantation. N Engl J Med. 2020 Apr 30;382(18):1696-1707. doi: 10.1056/NEJMoa1915152. Epub 2020 Mar 29.
- Nijenhuis VJ, Bennaghmouch N, Hassell M, Baan J Jr, van Kuijk JP, Agostoni P, van 't Hof A, Kievit PC, Veenstra L, van der Harst P, van den Heuvel AF, den Heijer P, Kelder JC, Deneer VH, van der Kley F, Onorati F, Collet JP, Maisano F, Latib A, Huber K, Stella PR, Ten Berg JM. Rationale and design of POPular-TAVI: antiPlatelet therapy fOr Patients undergoing Transcatheter Aortic Valve Implantation. Am Heart J. 2016 Mar;173:77-85. doi: 10.1016/j.ahj.2015.11.008. Epub 2015 Dec 1.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Ticagrelor
- Aspirin
- Vascular Diseases
- Cardiovascular Diseases
- Prasugrel
- Aortic Stenosis
- Thrombosis
- Warfarin
- Bleeding
- Myocardial Infarction
- Genetic Testing
- Platelet Aggregation Inhibitors
- Clopidogrel
- Ischemic stroke
- Heart Diseases
- Oral anticoagulation
- Myocardial Ischemia
- Aortic Valve Disease
- Embolism and Thrombosis
- Transcatheter Aortic Valve Implantation (TAVI)
- Transcatheter Aortic Valve Replacement (TAVR)
- Antithrombotic treatment
- Cytochrome P450 2C19 (CYP2C19)
- Prostaglandin-endoperoxide synthase 2(PTGS2)
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Heart Valve Diseases
- Myocardial Infarction
- Infarction
- Hemorrhage
- Aortic Valve Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Aspirin
- Clopidogrel
Other Study ID Numbers
- POPTAV006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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