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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)

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ClinicalTrials.gov Identifier: NCT02504216
Recruitment Status : Active, not recruiting
First Posted : July 21, 2015
Last Update Posted : October 10, 2019
Sponsor:
Collaborators:
Janssen Research & Development, LLC
Colorado Prevention Center
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE July 20, 2015
First Posted Date  ICMJE July 21, 2015
Last Update Posted Date October 10, 2019
Actual Study Start Date  ICMJE August 18, 2015
Estimated Primary Completion Date November 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
  • Time from randomization to the first occurrence of any of the following major thrombotic vascular events: MI (Myocardial infarction), ischemic stroke, CV (Cardiovascular) death, ALI (Acute limb ischemia), and major amputation [ Time Frame: Approximately 2 years ]
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.
  • Time from randomization to first occurrence of major bleeding events according to the Thrombolysis in Myocardial Infarction (TIMI) classification [ Time Frame: Approximately 2 years ]
    To evaluate the overall safety and tolerability.
Original Primary Outcome Measures  ICMJE
 (submitted: July 20, 2015)
  • Time from randomization to the first occurrence of any of the following major thrombotic vascular events: MI (Myocardial infarction), ischemic stroke, CV (Cardiovascular) death, ALI (Acute limb ischemia), and major amputation [ Time Frame: Approximately 2 years ]
  • Time from randomization to first occurrence of major bleeding events according to the Thrombolysis in Myocardial Infarction (TIMI) classification [ Time Frame: Approximately 2 years ]
Change History Complete list of historical versions of study NCT02504216 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
  • Time from randomization to first occurrence of myocardial infarction, ischemic stroke, coronary heart disease mortality, acute limb ischemia, and major amputation of a vascular etiology [ Time Frame: Approximately 2 years ]
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.
  • Time from randomization to first occurrence of an unplanned index limb revascularization for recurrent limb ischemia [ Time Frame: Approximately 2 years ]
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.
  • Time from randomization to first occurrence of hospitalization for a coronary or peripheral cause (either lower limb) of a thrombotic nature [ Time Frame: Approximately 2 years ]
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.
  • Time from randomization to the first occurrence of MI, ischemic stroke, all-cause mortality, acute limb ischemia, and major amputation of a vascular etiology [ Time Frame: Approximately 2 years ]
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.
  • Time from randomization to first occurrence of myocardial infarction, all-cause stroke, cardiovascular death, acute limb ischemia, and major amputation of a vascular etiology [ Time Frame: Approximately 2 years ]
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.
  • Time from randomization to first occurrence of all-cause mortality [ Time Frame: Approximately 2 years ]
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.
  • Time from randomization to first occurrence of venous thromboembolic (VTE) events [ Time Frame: Approximately 2 years ]
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2015)
  • Time from randomization to first occurrence of an index limb revascularization [ Time Frame: Approximately 2 years ]
  • Time from randomization to first occurrence of myocardial infarction, all-cause stroke, cardiovascular death, acute limb ischemia, and major amputation of a vascular etiology [ Time Frame: Approximately 2 years ]
  • Time from randomization to first occurrence of myocardial infarction, ischemic stroke, all-cause mortality,acute limb ischemia, and major amputation of a vascular etiology [ Time Frame: Approximately 2 years ]
  • Time from randomization to first occurrence of hospitalization for a coronary or peripheral cause (either lower limb) of a thrombotic nature [ Time Frame: Approximately 2 years ]
  • Time from randomization to first occurrence of venous thromboembolic (VTE) events [ Time Frame: Approximately 2 years ]
  • Time from randomization to all-cause mortality [ Time Frame: Approximately 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief Summary The purpose of study is to test whether rivaroxaban added to standard of care treatment, when compared to placebo, has 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Peripheral Artery Disease
Intervention  ICMJE
  • Drug: Rivaroxaban (Xarelto, BAY59-7939)
    2.5 mg, twice daily, orally, tablet
  • Drug: Rivaroxaban-Placebo
    matching placebo, twice daily, orally, tablet
Study Arms  ICMJE
  • Experimental: Rivaroxaban
    Rivaroxaban 2.5 mg orally twice daily (5 mg cumulative daily dose)
    Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)
  • Placebo Comparator: Placebo
    Rivaroxaban-placebo orally twice daily
    Intervention: Drug: Rivaroxaban-Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 9, 2018)
6564
Original Estimated Enrollment  ICMJE
 (submitted: July 20, 2015)
6500
Estimated Study Completion Date  ICMJE January 7, 2020
Estimated Primary Completion Date November 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   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
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02504216
Other Study ID Numbers  ICMJE 17454
2014-005569-58 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE
  • Janssen Research & Development, LLC
  • Colorado Prevention Center
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP