Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation

NCT ID: NCT02247128

Last Updated: 2020-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1016 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2020-04-30

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).

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).

Conditions

Aortic Valve Disease; Myocardial Infarction; Stroke; Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Aspirin + clopidogrel

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Aspirin monotherapy

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

OAC + clopicogrel

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

OAC monotherapy

Intervention Type: DRUG

Interventions

Aspirin + clopidogrel

Intervention Type: DRUG

Aspirin monotherapy

Intervention Type: DRUG

OAC + clopicogrel

Intervention Type: DRUG

OAC monotherapy

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Antonius Hospital

OTHER

Sponsor Role: lead

Responsible Party

J.M. ten Berg

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jurrien M ten Berg, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Pieter R Stella, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Utrecht (UMCU)

Locations

Algemeen Stedelijk Ziekenhuis

Aalst, , Belgium

Onze Lieve Vrouwe Ziekenhuis

Aalst, , Belgium

Imelda Ziekenhuis

Bonheiden, , Belgium

Algemeen Ziekenhuis Sint Jan

Bruges, , Belgium

Ziekenhuis Oost-Limburg

Genk, , Belgium

Universitair Ziekenhuis Leuven

Leuven, , Belgium

Charles university, Third Faculty of Medicine

Prague, , Czechia

National Institute Surgery Cardiaque Et De Cardiologie Interventionnelle

Luxembourg, , Luxembourg

Academic Medical Centre (AMC)

Amsterdam, North Holland, Netherlands

Isala Clinics

Zwolle, Overijssel, Netherlands

St. Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Medisch Spectrum Twente

Enschede, , Netherlands

University Medical Center

Groningen, , Netherlands

Universitair Medisch Centrum Leiden

Leiden, , Netherlands

Academic Hospital

Maastricht, , Netherlands

Haga Ziekenhuis

The Hague, , Netherlands

University Medical Center Utrecht (UMCU)

Utrecht, , Netherlands

Countries

Belgium; Czechia; Luxembourg; Netherlands

References

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.

Reference Type: DERIVED

PMID: 32865376 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32223116 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26920599 (View on PubMed)

Other Identifiers

POPTAV006

Identifier Type: -

Identifier Source: org_study_id