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.

Phase 1

• Conditions: Peripheral artery disease; MedDRA version: 18.1Level: LLTClassification code 10053375Term: Peripheral revascularizationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-005569-58-RO
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-16
• Study Completion: 2020-01-09
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6564

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified