Clinical trial NCT02504216: Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities
Official title: An International, Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Thrombotic Vascular Events in Patients With Symptomatic Peripheral Artery Disease Undergoing Lower Extremity Revascularization Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Artery Disease
Keywords: Rivaroxaban
Xarelto
Aspirin
Acetylic salicylic acid
Anticoagulant
Peripheral artery disease
Peripheral arterial disease
Revascularization
Acute limb ischemia
Amputation
Cardiovascular events
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
name: Colorado Prevention Center
First posted: 2015-07-21
Enrollment: 6564
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the heart and brain (CV death, MI, or stroke) or the legs (acute limb ischemia or major amputation) in patients who had undergone recent procedure(s) to improve the blood flow of their legs.


Eligibility criteria: Inclusion Criteria:

* Age ≥50
* Documented moderate to severe symptomatic lower extremity atherosclerotic peripheral artery disease
* Technically successful peripheral revascularization distal to the external iliac artery for symptomatic PAD (Peripheral artery disease) within the last 10 days prior to randomization

Exclusion Criteria:

* Patients undergoing revascularization for asymptomatic PAD or mild claudication without functional limitation of the index leg.
* Patients undergoing revascularization of the index leg to treat an asymptomatic or minimally symptomatic restenosis of a bypass graft or target lesion restenosis.
* Prior revascularization on the index leg within 10 days of the qualifying revascularization.
* Planned dual antiplatelet therapy (DAPT) use for the qualifying revascularization procedure of clopidogrel in addition to Acetylic salicylic acid (ASA) for \>6 months after the qualifying revascularization procedure; it is strongly recommended that any course of clopidogrel is kept to the minimum necessary in accordance with local standard of care and international practice guidelines (typically 30 days, or up to 60 days for some drug-coated products or devices) and is only allowed for up to 6 months for complex procedures or devices in the investigator's opinion that require longer use.
* Planned use of any additional antiplatelet agent other than clopidogrel and ASA after the qualifying revascularization procedure.

Primary outcomes:
measure: Primary Efficacy Outcome: Number of Participants With Composite of Myocardial Infarction (MI), Ischemic Stroke, Cardiovascular Death, Acute Limb Ischemia (ALI) and Major Amputation Due to a Vascular Etiology
timeFrame: For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean time in follow-up survival time until ECOD that date was 1109.76 days.
measure: Primary Safety Outcome: Number of Participants With TIMI (Thrombolysis in Myocardial Infarction) Major Bleeding
timeFrame: For each participant, the first occurrence of the primary safety outcome after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo).
Secondary outcomes:
measure: Number of Participants With Composite of MI, Ischemic Stroke, Coronary Heart Disease (CHD) Death, ALI, and Major Amputation of a Vascular Etiology
timeFrame: For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1108.79 days.
measure: Number of Participants With an Unplanned Index Limb Revascularization for Recurrent Limb Ischemia (Subsequent Index Leg Revascularization That Was Not Planned or Considered as Part of the Initial Treatment Plan at the Time of Randomization)
timeFrame: For each participant, the first occurrence of the efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1062.48 days.
measure: Number of Participants With Hospitalization for a Coronary or Peripheral Cause (Either Lower Limb) of a Thrombotic Nature
timeFrame: For each participant, the first occurrence of the efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1154.04 days
measure: Number of Participants With Composite of MI, Ischemic Stroke, All-cause Mortality (ACM), ALI, and Major Amputation of a Vascular Etiology
timeFrame: For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1085.13 days
measure: Number of Participants With Composite of MI, All-cause Stroke, Cardiovascular (CV) Death, Acute Limb Ischemia (ALI), and Major Amputation of a Vascular Etiology
timeFrame: For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1108.29 days
measure: Number of Mortality (All-cause)
timeFrame: For each participant, the first occurrence of the outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1188.48 days
measure: Number of Participants With Venous Thromboembolic (VTE) Events
timeFrame: For each participant, the first occurrence of the outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1187.65 days
measure: Secondary Safety Outcome: Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeding
timeFrame: For each participant, the first occurrence of the major bleeding events according to the ISTH classification after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo).
measure: Secondary Safety Outcome: Number of Participants With BARC (Bleeding Academic Research Consortium) Type 3b and Above Bleeding Events
timeFrame: For each participant, the first occurrence of the type 3b and above bleeding events according to the BARC classification after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo)
Other outcomes:
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country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Daugavpils
country: Latvia
city: Liepaja
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
city: Panevezys
country: Lithuania
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
city: Den Bosch
country: Netherlands
city: Eindhoven
country: Netherlands
city: Enschede
country: Netherlands
city: Heerlen
country: Netherlands
city: Utrecht
country: Netherlands
city: Veldhoven
country: Netherlands
city: Zwolle
country: Netherlands
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Gdynia
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Almada
country: Portugal
state: Setúbal
city: Lisboa
country: Portugal
city: Ponta Delgada
country: Portugal
city: Porto
country: Portugal
city: Porto
country: Portugal
city: Vila Nova de Gaia
country: Portugal
city: Pitesti
country: Romania
state: Arges
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Cluj Napoca
country: Romania
city: Iasi
country: Romania
city: Oradea
country: Romania
city: Targu Mures
country: Romania
city: Timisoara
country: Romania
city: Kemerovo
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Rostov-on-Don
country: Russian Federation
city: Ryazan
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Tver
country: Russian Federation
city: Voronezh
country: Russian Federation
city: Belgrade
country: Serbia
city: Belgrade
country: Serbia
city: Belgrade
country: Serbia
city: Beograd
country: Serbia
city: Nis
country: Serbia
city: Bardejov
country: Slovakia
city: Bratislava 37
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Dunajska Streda
country: Slovakia
city: Kosice
country: Slovakia
city: Nitra
country: Slovakia
city: Nove Zamky
country: Slovakia
city: Trnava
country: Slovakia
city: Zilina
country: Slovakia
city: Cádiz
country: Spain
state: Andalucía
city: L'Hospitalet de Llobregat
country: Spain
state: Barcelona
city: Sabadell
country: Spain
state: Barcelona
city: A Coruña
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Ciudad Real
country: Spain
city: Granada
country: Spain
city: Madrid
country: Spain
city: Pamplona
country: Spain
city: Tarragona
country: Spain
city: Göteborg
country: Sweden
city: Linköping
country: Sweden
city: Malmö
country: Sweden
city: Solna
country: Sweden
city: Växjö
country: Sweden
city: Basel
country: Switzerland
state: Basel-Stadt
city: Chur
country: Switzerland
state: Graubünden
city: St. Gallen
country: Switzerland
state: Sankt Gallen
city: Baden
country: Switzerland
city: Bern
country: Switzerland
city: Fribourg
country: Switzerland
city: Genève
country: Switzerland
city: Luzern
country: Switzerland
city: Hsinchu City
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Khon Kaen
country: Thailand
city: Songkla
country: Thailand
city: Dnipro
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Zaporizhzhya
country: Ukraine
city: Carlisle
country: United Kingdom
state: Cumbria
city: Hull
country: United Kingdom
state: Humberside
city: Harrow
country: United Kingdom
state: London
city: Doncaster
country: United Kingdom
state: South Yorkshire
city: Newcastle Upon Tyne
country: United Kingdom
state: Tyne And Wear
city: Birmingham
country: United Kingdom
state: West Midlands
city: Leeds
country: United Kingdom
state: West Yorkshire
city: Worcester
country: United Kingdom
state: Worcestershire
city: Cambridge
country: United Kingdom
city: Cheltenham
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Manchester
country: United Kingdom
city: Sheffield
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Hess CN, Baumgartner I, Anand SS, Nehler MR, Patel MR, Debus ES, Szarek M, Capell W, Muehlhofer E, Berkowitz SD, Haskell LP, Bauersachs RM, Bonaca MP, Hsia J. Sex-Based Differences in Outcomes Following Peripheral Artery Revascularization: Insights From VOYAGER PAD. J Am Heart Assoc. 2022 Jun 21;11(12):e024655. doi: 10.1161/JAHA.121.024655. Epub 2022 Jun 14.
citation: Hogan SE, Nehler MR, Anand S, Patel MR, Debus S, Jackson MT, Buchanan C, King RW, Hess C, Muehlhofer E, Haskell LP, Bauersachs RM, Berkowitz SD, Hsia J, Bonaca MP. Improvement in walking impairment following surgical and endovascular revascularization: Insights from VOYAGER PAD. Vasc Med. 2022 Aug;27(4):343-349. doi: 10.1177/1358863X221085606. Epub 2022 Apr 25.
citation: Hess CN, Patel MR, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Fanelli F, Yeh RW, Secemsky EA, Beckman JA, Mauri L, Govsyeyev N, Capell WH, Brackin T, Berkowitz SD, Muehlhofer E, Haskell LP, Hiatt WR, Bonaca MP. Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD. J Am Coll Cardiol. 2021 Nov 2;78(18):1768-1778. doi: 10.1016/j.jacc.2021.08.052.
citation: Debus ES, Nehler MR, Govsyeyev N, Bauersachs RM, Anand SS, Patel MR, Fanelli F, Capell WH, Brackin T, Hinterreiter F, Krievins D, Nault P, Piffaretti G, Svetlikov A, Jaeger N, Hess CN, Sillesen HH, Conte M, Mills J, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR, Bonaca MP. Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial. Circulation. 2021 Oct 5;144(14):1104-1116. doi: 10.1161/CIRCULATIONAHA.121.054835. Epub 2021 Aug 12.
citation: Bauersachs RM, Szarek M, Brodmann M, Gudz I, Debus ES, Nehler MR, Anand SS, Patel MR, Hess CN, Capell WH, Rogers K, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR, Bonaca MP; VOYAGER PAD Committees and Investigators. Total Ischemic Event Reduction With Rivaroxaban After Peripheral Arterial Revascularization in the VOYAGER PAD Trial. J Am Coll Cardiol. 2021 Jul 27;78(4):317-326. doi: 10.1016/j.jacc.2021.05.003. Epub 2021 May 16.
citation: Hiatt WR, Bonaca MP, Patel MR, Nehler MR, Debus ES, Anand SS, Capell WH, Brackin T, Jaeger N, Hess CN, Pap AF, Berkowitz SD, Muehlhofer E, Haskell L, Brasil D, Madaric J, Sillesen H, Szalay D, Bauersachs R. Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization: Impact of Concomitant Clopidogrel on Efficacy and Safety. Circulation. 2020 Dec 8;142(23):2219-2230. doi: 10.1161/CIRCULATIONAHA.120.050465. Epub 2020 Nov 3.
citation: Bonaca MP, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Patel MR, Fanelli F, Capell WH, Diao L, Jaeger N, Hess CN, Pap AF, Kittelson JM, Gudz I, Matyas L, Krievins DK, Diaz R, Brodmann M, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR. Rivaroxaban in Peripheral Artery Disease after Revascularization. N Engl J Med. 2020 May 21;382(21):1994-2004. doi: 10.1056/NEJMoa2000052. Epub 2020 Mar 28.
citation: Capell WH, Bonaca MP, Nehler MR, Chen E, Kittelson JM, Anand SS, Berkowitz SD, Debus ES, Fanelli F, Haskell L, Patel MR, Bauersachs R, Hiatt WR. Rationale and design for the Vascular Outcomes study of ASA along with rivaroxaban in endovascular or surgical limb revascularization for peripheral artery disease (VOYAGER PAD). Am Heart J. 2018 May;199:83-91. doi: 10.1016/j.ahj.2018.01.011. Epub 2018 Feb 3.