Trial Condition(s):

Cardiovascular Disease, Coronary artery disease

Exploring the efficacy and safety of Rivaroxaban to support elective percutaneous coronary intervention (X-PLORER)

Bayer Identifier:

15572

ClinicalTrials.gov Identifier:

NCT01442792

EudraCT Number:

2011-001094-58

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
108
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

LIEGE, Belgium, 4000

Status
Completed
 
Locations

Investigative Site

HASSELT, Belgium, 3500

Status
Completed
 
Locations

Investigative Site

AMSTERDAM, Netherlands, 1091 AC

Status
Completed
 
Locations

Investigative Site

EINDHOVEN, Netherlands, 5623 EJ

Status
Completed
 
Locations

Investigative Site

ZWOLLE, Netherlands, 8011 JW

Status
Completed
 
Locations

Investigative Site

AMSTERDAM, Netherlands, 1105 AZ

Status
Completed
 
Locations

Investigative Site

ROESELARE, Belgium, 8800

Status
Completed
 

Trial Design