Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation (POPular-TAVI)
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ClinicalTrials.gov Identifier: NCT02247128 |
Recruitment Status :
Completed
First Posted : September 23, 2014
Last Update Posted : April 30, 2020
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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).
Condition or disease | Intervention/treatment | Phase |
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Aortic Valve Disease Myocardial Infarction Stroke Bleeding | Drug: Aspirin + clopidogrel Drug: Aspirin monotherapy Drug: OAC + clopicogrel Drug: OAC monotherapy | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1016 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation |
Study Start Date : | January 2014 |
Actual Primary Completion Date : | March 2020 |
Actual Study Completion Date : | April 2020 |
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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Drug: Aspirin + clopidogrel |
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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Drug: Aspirin monotherapy |
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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Drug: OAC + clopicogrel |
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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Drug: OAC monotherapy |
- Safety endpoint [ Time Frame: 1 year ]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).
- Net-clinical benefit endpoint [ Time Frame: 1 year ]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.
- Efficacy endpoint [ Time Frame: 1 year ]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.
- Pharmacoeconomics endpoint [ Time Frame: 1 year ]Outcome measure is quality-adjusted life years

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Cohort A
1. Patient has provided written informed consent.
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Cohort B
- Need for long-term oral anticoagulation;
- Patient has provided written informed consent.
Exclusion Criteria:
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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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247128

Principal Investigator: | Jurrien M ten Berg, PhD, MD | St. Antonius Hospital | |
Principal Investigator: | Pieter R Stella, MD, PhD | University Medical Center Utrecht (UMCU) |
Responsible Party: | J.M. ten Berg, Prof. Dr., St. Antonius Hospital |
ClinicalTrials.gov Identifier: | NCT02247128 |
Other Study ID Numbers: |
POPTAV006 |
First Posted: | September 23, 2014 Key Record Dates |
Last Update Posted: | April 30, 2020 |
Last Verified: | April 2020 |
Transcatheter Aortic Valve Implantation (TAVI) Transcatheter Aortic Valve Replacement (TAVR) Aortic Valve Disease Aortic Stenosis Myocardial Infarction Ischemic stroke Bleeding Thrombosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
Embolism and Thrombosis Aspirin Clopidogrel Prasugrel Ticagrelor Antithrombotic treatment Oral anticoagulation Warfarin Platelet Aggregation Inhibitors Genetic Testing Cytochrome P450 2C19 (CYP2C19) Prostaglandin-endoperoxide synthase 2(PTGS2) |
Myocardial Infarction Aortic Valve Disease Infarction Hemorrhage Vascular Diseases Cardiovascular Diseases Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Heart Valve Diseases Aspirin Clopidogrel Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Purinergic P2Y Receptor Antagonists |