Exploring the Efficacy and Safety of Rivaroxaban to Support Elective Percutaneous Coronary Intervention (X-PLORER)

Bayer

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease; Cardiovascular Disease

Treatments: Drug: Rivaroxaban (Xarelto, BAY59-7939) and UFH; Drug: UFH; Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01442792

2011-001094-58 (EudraCT Number)

15572

Details and patient eligibility

About

Balloon angioplasty (Percutaneous Coronary Intervention (PCI)) is commonly used to treat patients with obstructive coronary artery disease (CAD). Although PCI is highly effective for the management of CAD, it can potentiate an existing prothrombotic state around lesion areas. A certain level of anticoagulation is required to perform planned PCI safely and to minimize the periprocedural risk of thrombosis and its attendant complications, including myocardial ischemia and infarction (heart attack). Many different anti-thrombotic regimens have been investigated and are currently in use. The aim of this study is to explore whether Rivaroxaban, as compared to unfractionated heparin, on the background of standard dual antiplatelet therapy, can effectively suppress thrombosis and related adverse ischemic events, upon balloon inflation and stent expansion, during elective PCI, without increasing bleeding. The treatment assignment will be done in a semi-blinded design, eg, no blinding for randomization either to Rivaroxaban (one of the three arms) or the control (UFH) group. However, all will be blinded for the treatment dose of rivaroxaban (either 10mg or 20 mg).The 10 mg rivaroxaban plus 50 IU UFH arm will not be blinded.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subject aged 18 years or more with no upper age limit and willing to comply with the protocol
• Symptomatic coronary artery disease due to undergo an elective (non-emergent) Percutaneous Coronary Intervention (PCI) on one or two lesions in the native coronary vessel(s). Cardiac standard troponin at baseline is within the normal limits

Exclusion criteria

• Conditions that may increase the risk of the PCI procedure
• Conditions that may increase the risk of bleeding
• Significant valvular heart disease
• Calculated creatinine clearance ≤30 mL/min
• Current use of anticoagulant drugs including Vitamin K antagonist (VKA), factor IIa or factor XA inhibitors
• Chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs)
• Chronic treatment with aspirin > 100mg

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

108 participants in 4 patient groups

Arm 1

Active Comparator group

Treatment:

Drug: UFH

Arm 2

Experimental group

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Arm 3

Experimental group

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Arm 4

Experimental group

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939) and UFH