Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation (POPular-TAVI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02247128
Recruitment Status : Active, not recruiting
First Posted : September 23, 2014
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
J.M. ten Berg, St. Antonius Hospital

Brief Summary:

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
Aortic Valve Disease Myocardial Infarction Stroke Bleeding Drug: Aspirin + clopidogrel Drug: Aspirin monotherapy Drug: OAC + clopicogrel Drug: OAC monotherapy Phase 4

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 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
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
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.
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.
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.
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.
Drug: OAC monotherapy



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. Pharmacoeconomics endpoint [ Time Frame: 1 year ]
    Outcome measure is quality-adjusted life years



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cohort A

    1. Patient has provided written informed consent.

  • Cohort B

    1. Need for long-term oral anticoagulation;
    2. Patient has provided written informed consent.

Exclusion Criteria:

  • Cohort A

    1. Need for long-term oral anticoagulation;
    2. Drug-eluting stent implantation within 3 months prior to TAVI procedure;
    3. Bare-metal stent implantation within 1 month prior to TAVI procedure;
    4. Allergy or intolerance to aspirin or clopidogrel.
  • Cohort B

    1. Drug-eluting stent implantation within 3 months prior to TAVI procedure;
    2. Bare-metal stent implantation within 1 month prior to TAVI procedure;
    3. Allergy or intolerance to (N)OAC or clopidogrel.

Information from the National Library of Medicine

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


Locations
Layout table for location information
Belgium
Algemeen Stedelijk Ziekenhuis
Aalst, Belgium
Onze Lieve Vrouwe Ziekenhuis
Aalst, Belgium
Imelda Ziekenhuis
Bonheiden, Belgium
Algemeen Ziekenhuis Sint Jan
Brugge, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
Czechia
Charles university, Third Faculty of Medicine
Prague, Czechia
Luxembourg
National Institute Surgery Cardiaque Et De Cardiologie Interventionnelle
Luxembourg, Luxembourg
Netherlands
Academic Medical Centre (AMC)
Amsterdam, Noord Holland, Netherlands, 1105 AZ
Isala Clinics
Zwolle, Overijssel, Netherlands, 8011 JW
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3435CM
Haga Ziekenhuis
Den Haag, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
University Medical Center
Groningen, Netherlands, 9700 RB
Universitair Medisch Centrum Leiden
Leiden, Netherlands
Academic Hospital
Maastricht, Netherlands, 6229 HX
University Medical Center Utrecht (UMCU)
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
St. Antonius Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jurrien M ten Berg, PhD, MD St. Antonius Hospital
Principal Investigator: Pieter R Stella, MD, PhD University Medical Center Utrecht (UMCU)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: J.M. ten Berg, Prof. Dr., St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT02247128     History of Changes
Other Study ID Numbers: POPTAV006
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Keywords provided by J.M. ten Berg, St. Antonius Hospital:
Ischemic stroke
Myocardial Ischemia
Aspirin
Clopidogrel
Transcatheter Aortic Valve Implantation (TAVI)
Transcatheter Aortic Valve Replacement (TAVR)
Aortic Valve Disease
Aortic Stenosis
Myocardial Infarction
Bleeding
Thrombosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis
Prasugrel
Ticagrelor
Antithrombotic treatment
Oral anticoagulation
Warfarin
Platelet Aggregation Inhibitors
Genetic Testing
Cytochrome P450 2C19 (CYP2C19)
Prostaglandin-endoperoxide synthase 2(PTGS2)
Additional relevant MeSH terms:
Layout table for MeSH terms
Ischemia
Myocardial Ischemia
Aspirin
Clopidogrel
Myocardial Infarction
Infarction
Hemorrhage
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis
Heart Diseases
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
Purinergic P2 Receptor Antagonists
Purinergic Antagonists