ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

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: NCT02504216
Recruitment Status : Active, not recruiting
First Posted : July 21, 2015
Last Update Posted : June 8, 2018
Sponsor:
Collaborators:
Janssen Research & Development, LLC
Colorado Prevention Center
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Rivaroxaban-Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : August 18, 2015
Estimated Primary Completion Date : January 15, 2019
Estimated Study Completion Date : January 15, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Experimental: Rivaroxaban
Rivaroxaban 2.5 mg orally twice daily (5 mg cumulative daily dose)
Drug: Rivaroxaban (Xarelto, BAY59-7939)
2.5 mg, twice daily, orally, tablet

Placebo Comparator: Placebo
Rivaroxaban-placebo orally twice daily
Drug: Rivaroxaban-Placebo
matching placebo, twice daily, orally, tablet




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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.


Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02504216


  Show 532 Study Locations
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Colorado Prevention Center
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02504216     History of Changes
Other Study ID Numbers: 17454
2014-005569-58 ( EudraCT Number )
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Rivaroxaban
Xarelto
Aspirin
Acetylic salicylic acid
Anticoagulant
Peripheral artery disease
Peripheral arterial disease
Revascularization
Acute limb ischemia
Amputation
Cardiovascular events

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants