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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 January 2021
• Main ID: NCT02504216
• Date of registration: 20/07/2015
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: 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 VOYAGER PAD
• Scientific 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
• Date of first enrolment: August 18, 2015
• Target sample size: 6564
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02504216
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Czechia, Denmark, Estonia, Finland, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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.



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Artery Disease

Intervention(s)

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Drug: Rivaroxaban-Placebo

Primary Outcome(s)

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 [Time Frame: 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.]

Primary Safety Outcome: Number of Participants With TIMI (Thrombolysis in Myocardial Infarction) Major Bleeding [Time Frame: 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 Outcome(s)

Number of Participants With Composite of MI, All-cause Stroke, Cardiovascular (CV) Death, Acute Limb Ischemia (ALI), and Major Amputation of a Vascular Etiology [Time Frame: 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]

Secondary Safety Outcome: Number of Participants With BARC (Bleeding Academic Research Consortium) Type 3b and Above Bleeding Events [Time Frame: 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)]

Number of Participants With Composite of MI, Ischemic Stroke, Coronary Heart Disease (CHD) Death, ALI, and Major Amputation of a Vascular Etiology [Time Frame: 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.]

Number of Participants With Composite of MI, Ischemic Stroke, All-cause Mortality (ACM), ALI, and Major Amputation of a Vascular Etiology [Time Frame: 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]

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) [Time Frame: 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.]

Number of Participants With Hospitalization for a Coronary or Peripheral Cause (Either Lower Limb) of a Thrombotic Nature [Time Frame: 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]

Number of Participants With Venous Thromboembolic (VTE) Events [Time Frame: 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]

Secondary Safety Outcome: Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeding [Time Frame: 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).]

Number of Mortality (All-cause) [Time Frame: 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]

Secondary ID(s)

2014-005569-58

17454

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Janssen Research & Development, LLC

Colorado Prevention Center

Results

• Results available: Yes
• Date Posted: 08/12/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02504216