An international, multicenter, randomized, double-blind, placebocontrolled 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

Phase 3

Completed

Conditions: peripheral vascular disease
reduced blood flow due to narrowed arteries
10035534
10003184
10014523

Registration Number: NL-OMON42582

Lead Sponsor: Bayer Healthcare AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 96

Inclusion Criteria

age *50,
* documented moderate to severe symptomatic lower extremity
peripheral artery occlusive disease as evidenced by ALL of the
following:
a. clinically, by functional limitations in walking activity, ischemic
rest pain or ischemic ulceration,
b. anatomically, by imaging evidence of arterial occlusive disease
below the inguinal ligament within 6 months prior to or at the
time of the qualifying revascularization,
AND
c. hemodynamically (within 6 months prior to, or at the time of, the
qualifying revascularization) by:
* an ABI * 0.80 or TBI * 0.60 of the index leg (in the event of
non-compressible ankle arteries) for patients without a prior
history of limb revascularization on the index leg,
OR
* an ABI * 0.85 or TBI * 0.65 of the index leg (in the event of
non-compressible ankle arteries) for patients with a prior
history of limb revascularization on the index leg.

Exclusion Criteria

- patients undergoing revascularization for asymptomatic PAD, 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 (DAPT) use for the qualifying
revascularization procedure of clopidogrel in addition to ASA for
>30 days after the qualifying revascularization procedure
- Planned DAPT use for any other indication(s) with any P2Y12
antagonists in addition to ASA after the qualifying revascularization
procedure

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy outcome variable will be a composite endpoint<br /><br>consisting of the time from randomization to the first occurrence of any of the<br /><br>following major thrombotic vascular events: MI, ischemic stroke, CV death,<br /><br>ALI, and major amputation due to a vascular etiology.<br /><br><br /><br>The primary safety outcome will be major bleeding events according to the<br /><br>Thrombolysis in Myocardial Infarction (TIMI) classification.</p><br>

Secondary Outcome Measures