Efficacy and safety of rivaroxaban in reducing the risk of major thrombotic vascular events in subjects with peripheral artery disease undergoing peripheral revascularization procedures of the lower extremities.

• Register: EUCTR
• Last refreshed on: 17 January 2022
• Main ID: EUCTR2014-005569-58-RO
• Date of registration: 16/02/2016
• Prospective Registration: No
• Primary sponsor: Bayer HealthCare AG
• Public title: Efficacy and safety of rivaroxaban in reducing the risk of major thrombotic vascular events in subjects with peripheral artery disease undergoing peripheral revascularization procedures of the lower extremities.
• 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 - VOYAGER PAD
• Date of first enrolment: 21/12/2015
• Target sample size: 6500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005569-58
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer HealthCare AG

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer HealthCare AG

Key inclusion & exclusion criteria

Inclusion criteria:
- Age =50

- Documented moderate to severe symptomatic lower extremity peripheral artery occlusive disease

- Technically successful peripheral infra-inguinal revascularization within the last 7 days prior to randomization
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4290

Exclusion criteria:
- Patients undergoing revascularization for asymptomatic peripherial artery disease, mild
claudication without functional limitation or major tissue loss (including severe ischemic ulcers or gangrene) 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 8 weeks of the qualifying revascularization

- Planned dual antiplatelet therapy use for the qualifying revascularization procedure of clopidogrel in addition to Aspirin for >30 days after the qualifying revascularization procedure

- Planned dual antiplatelet therapy use for any other indication(s) with any P2Y12 antagonists in addition to Aspirin after the qualifying revascularization procedure


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Peripheral artery disease
MedDRA version: 18.1 Level: LLT Classification code 10053375 Term: Peripheral revascularization System Organ Class: 100000004865

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Trade Name: Xarelto 2.5 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RIVAROXABAN
CAS Number: 366789-02-8
Current Sponsor code: BAY 59-7939
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: - To evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of index limb revascularization;
- To evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of MI, ischemic stroke, coronary heart disease mortality, ALI, and major amputation of a vascular etiology;
- To evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of MI, ischemic stroke, all-cause mortality, ALI, and major amputation of a vascular etiology;
- To evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of vascular hospitalizations for a coronary or peripheral event (either limb) of a thrombotic nature;
- To evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of MI, all-cause stroke, CV death, ALI, and major amputation of a vascular etiology;
- To evaluate the efficacy of rivaroxaban in reducing the risk of venous thromboembolic (VTE) events;

Main Objective: To evaluate whether rivaroxaban added to acetylsalicylic acid (ASA) is superior to ASA alone in reducing the risk of major thrombotic vascular events (defined as myocardial infarction (MI), ischemic stroke, cardiovascular (CV) death, acute limb ischemia (ALI), and
major amputation of a vascular etiology) in symptomatic PAD patients undergoing lower extremity revascularization procedure.

To evaluate the overall safety and tolerability of rivaroxaban added to
ASA compared to ASA alone.

Primary end point(s): 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

2. Time from randomization to first occurrence of major bleeding events according to the Thrombolysis in Myocardial Infarction (TIMI) classification

Timepoint(s) of evaluation of this end point: Approximately 2 years

Secondary Outcome(s)

Secondary end point(s): 1. Time from randomization to first occurrence of an index limb revascularization

2. 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

3. Time from randomization to first occurrence of myocardial infarction, ischemic stroke, all-cause mortality,acute limb
ischemia, and major amputation of a vascular etiology

4. Time from randomization to first occurrence of hospitalization for a coronary or peripheral cause (either lower limb) of a thrombotic nature

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

6. Time from randomization to first occurrence of venous thromboembolic (VTE) events

7. Time from randomization to all-cause mortality

Timepoint(s) of evaluation of this end point: Approximately 2 years

Secondary ID(s)

2014-005569-58-CZ

BAY59-7939/17454

Source(s) of Monetary Support

Janssen Research & Development, LLC

Bayer HealthCare AG

Ethics review

Status: Approved
Approval date: 12/11/2015
Contact:

Results

• Results available: Yes
• Date Posted: 26/11/2020
• Date Completed: 09/01/2020
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-005569-58/results