MedPath

Vascular Outcomes studY of ASA alonG with rivaroxaban in Endovascular or surgical limb Revascularization for peripheral artery disease (PAD).

Phase 1
Conditions
Peripheral artery disease
MedDRA version: 21.1Level: LLTClassification code 10053375Term: Peripheral revascularizationSystem Organ Class: 100000004865
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Registration Number
EUCTR2014-005569-58-IT
Lead Sponsor
BAYER AG
Brief Summary

Not available

Detailed Description

Not available

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
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath