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Completed

NCT Number: 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

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.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bahía Blanca, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

2.5 mg, twice daily, orally, tablet

Rivaroxaban-Placebo

Drug

matching placebo, twice daily, orally, tablet

Primary outcomes

  1. 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.

    Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.

  2. 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).

    Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.

Secondary outcomes

  1. 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.

    Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.

  2. 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.

    Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.

  3. 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

    Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.

  4. 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

    Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.

  5. 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

    Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.

  6. 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

  7. 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

    Venous thromboembolic events were reported by investigator only.

  8. 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).

    Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.

  9. 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)

    Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Colorado Prevention Center
  • Janssen Research & Development, LLC

Registry information

Official study 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

Acronym: VOYAGER PAD

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Jul 21, 2015
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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