The effect of rivaroxaban with aspirin on improving the vascular function in patients with lower extremity arterial disease.

DUAL pathway inhibition (low-dose rivaroxaban and aspirin) as compared to aspirin only to improve endothelial function in peripheral artery disease (PAD) - DUAL-PAD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003679-20-NL

Enrollment

330

Registered

2021-03-06

Start date

2020-03-11

Completion date

Unknown

Last updated

2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

symptomatic or stable pheripheral artery disease

Interventions

Trade Name: Xarelto Pharmaceutical Form: Tablet Trade Name: Aspirin Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Symptomatic or stable lower extremity peripheral artery disease patients (Rutherford stages 1-6) with an indication for single antiplatelet therapy according to international (ESC) guidelines - 18 years or older - Written informed consent 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 230

Exclusion criteria

Exclusion criteria: - Patients having or at risk of major bleeding - Patients with prosthetic valves - Patients with a history of asthma attacks caused by salicylates - Severe renal impairment (creatinine clearance 15 mg - Pregnant or lactating - Known hypersensitivity to aspirin or rivaroxaban

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the effectiveness of low-dose rivaroxaban + aspirin in improving endothelial function (i.e. CAR) in patients with (a) intermittent claudication Rutherford stages 1-3) and (b) critical limb ischemia (Rutherford stages 4-6). ;Secondary Objective: To study the effectiveness of low-dose rivaroxaban with acetylsalicylic acid in decreasing serum endothelin-1 levels in patients with (a) intermittent claudication (Fontaine stages 1-2) and (b) critical limb ischemia (Fontaine stages 3-4).;Primary end point(s): The primary parameter is the dichotomized carotid artery reactivity (CAR) after 3 months treatment. The change in the proportion of patients with CAR constriction from baseline (aspirin alone) to 3 months after adding low-dose rivaroxaban is the primary outcome.;Timepoint(s) of evaluation of this end point: 3 months after start rivaroxaban with aspirin combination treatment	—

Measure

Time frame

Main Objective: To study the effectiveness of low-dose rivaroxaban + aspirin in improving endothelial function (i.e. CAR) in patients with (a) intermittent claudication Rutherford stages 1-3) and (b) critical limb ischemia (Rutherford stages 4-6). ;Secondary Objective: To study the effectiveness of low-dose rivaroxaban with acetylsalicylic acid in decreasing serum endothelin-1 levels in patients with (a) intermittent claudication (Fontaine stages 1-2) and (b) critical limb ischemia (Fontaine stages 3-4).;Primary end point(s): The primary parameter is the dichotomized carotid artery reactivity (CAR) after 3 months treatment. The change in the proportion of patients with CAR constriction from baseline (aspirin alone) to 3 months after adding low-dose rivaroxaban is the primary outcome.;Timepoint(s) of evaluation of this end point: 3 months after start rivaroxaban with aspirin combination treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Exploratory outcomes are serum endothelin-1 levels, major adverse cardiovascular events, major adverse limb events, major bleeding complications and medication adherence.;Timepoint(s) of evaluation of this end point: 3 months after start rivaroxaban with aspirin combination treatment	—

Countries

Netherlands

Contacts

Public ContactVascular surgery

Radboudumc

Loes.H.Willems@radboudumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026