Vascular Outcomes studY of ASA alonG with rivaroxaban in Endovascular or surgical limb Revascularization for peripheral artery disease (PAD).
- Conditions
- Peripheral artery diseaseMedDRA version: 21.1Level: LLTClassification code 10053375Term: Peripheral revascularizationSystem Organ Class: 100000004865Therapeutic 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
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
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
Name Time Method
- Secondary Outcome Measures
Name Time Method