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

Primary Purpose

Cardiovascular Disease, Coronary Artery Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
UFH
Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban (Xarelto, BAY59-7939) and UFH
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Disease focused on measuring Angioplasty, Balloon, Coronary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

Outcomes

Primary Outcome Measures

The percentage of subjects who require bail-out anticoagulant therapy in the context of an ischemic coronary event
The percentage of subjects who experience an angiographic flow limiting thrombotic event
The percentage of subjects who experience thrombus formation on the Percutaneous Coronary Intervention equipment
The percentage of subjects who experience an Myocardial Infarction due to the Percutaneous Coronary Intervention equipment procedure

Secondary Outcome Measures

Bleeding (Thrombolysis in Myocardial Infarction major, minor and Bleeding academic research consortium type 2, 3 and 5)
Composite of clinical ischemic events (all death, non-fatal Myocardial Infarction, non-fatal stroke and target lesion revascularization
Coagulation profile of Rivaroxaban (Activated Partial Thromboplastin Time)
Coagulation profile of Rivaroxaban (Prothrombin time)
Coagulation profile of Rivaroxaban (Thrombin Time)
Coagulation profile of Rivaroxaban (Prothrombin Fragment 1+2)
Coagulation profile of Rivaroxaban (Thrombin Anti-thrombin III Complexes)
Coagulation profile of Rivaroxaban (Anti-Xa Activity)
Coagulation profile of Rivaroxaban (endogenous thrombin potential)
Plasma concentration of Rivaroxaban

Full Information

First Posted
August 18, 2011
Last Updated
June 20, 2022
Sponsor
Bayer
Collaborators
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01442792
Brief Title
Exploring the Efficacy and Safety of Rivaroxaban to Support Elective Percutaneous Coronary Intervention
Acronym
X-PLORER
Official Title
Prospective, Multi-center, Randomized, Heparin-controlled Dose-finding Trial to Evaluate the Efficacy and Safety of Rivaroxaban, a Direct Factor Xa Inhibitor, on the Background of Standard Dual Antiplatelet Therapy to Support Elective Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 12, 2011 (Actual)
Primary Completion Date
January 29, 2013 (Actual)
Study Completion Date
March 4, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Coronary Artery Disease
Keywords
Angioplasty, Balloon, Coronary

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Experimental
Arm Title
Arm 4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
UFH
Intervention Description
Unfractionated Heparin: 70-100 IU/Kg bolus and adjusted upon activated coagulation time (ACT) 250 300 seconds
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban (Xarelto, BAY59-7939)
Intervention Description
10 mg single dose Rivaroxaban (per os)
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban (Xarelto, BAY59-7939)
Intervention Description
20 mg single dose Rivaroxaban (per os)
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban (Xarelto, BAY59-7939) and UFH
Intervention Description
10 mg single dose Rivaroxaban (per os) followed by bolus 50 IU/Kg unfractionated heparin (UFH)
Primary Outcome Measure Information:
Title
The percentage of subjects who require bail-out anticoagulant therapy in the context of an ischemic coronary event
Time Frame
During the index Percutaneous Coronary Intervention procedure
Title
The percentage of subjects who experience an angiographic flow limiting thrombotic event
Time Frame
During the index Percutaneous Coronary Intervention procedure
Title
The percentage of subjects who experience thrombus formation on the Percutaneous Coronary Intervention equipment
Time Frame
During the index Percutaneous Coronary Intervention procedure
Title
The percentage of subjects who experience an Myocardial Infarction due to the Percutaneous Coronary Intervention equipment procedure
Time Frame
During the index Percutaneous Coronary Intervention procedure
Secondary Outcome Measure Information:
Title
Bleeding (Thrombolysis in Myocardial Infarction major, minor and Bleeding academic research consortium type 2, 3 and 5)
Time Frame
Up to 30 days post index Percutaneous coronary intervention procedure
Title
Composite of clinical ischemic events (all death, non-fatal Myocardial Infarction, non-fatal stroke and target lesion revascularization
Time Frame
Up to 30 days post index Percutaneous coronary intervention procedure
Title
Coagulation profile of Rivaroxaban (Activated Partial Thromboplastin Time)
Time Frame
1 to 5 days prior percutaneous coronary intervention (PCI) and the day of PCI (from 2-4 h pre PCI until 48h post PCI or discharge of patient if earlier)
Title
Coagulation profile of Rivaroxaban (Prothrombin time)
Time Frame
1 to 5 days prior percutaneous coronary intervention (PCI) and the day of PCI (from 2-4 h pre PCI until 48h post PCI or discharge of patient if earlier)
Title
Coagulation profile of Rivaroxaban (Thrombin Time)
Time Frame
1 to 5 days prior percutaneous coronary intervention (PCI) and the day of PCI (from 2-4 h pre PCI until 48h post PCI or discharge of patient if earlier)
Title
Coagulation profile of Rivaroxaban (Prothrombin Fragment 1+2)
Time Frame
1 to 5 days prior percutaneous coronary intervention (PCI) and the day of PCI (from 2-4 h pre PCI until 48h post PCI or discharge of patient if earlier)
Title
Coagulation profile of Rivaroxaban (Thrombin Anti-thrombin III Complexes)
Time Frame
1 to 5 days prior percutaneous coronary intervention (PCI) and the day of PCI (from 2-4 h pre PCI until 48h post PCI or discharge of patient if earlier)
Title
Coagulation profile of Rivaroxaban (Anti-Xa Activity)
Time Frame
1 to 5 days prior percutaneous coronary intervention (PCI) and the day of PCI (from 2-4 h pre PCI until 48h post PCI or discharge of patient if earlier)
Title
Coagulation profile of Rivaroxaban (endogenous thrombin potential)
Time Frame
1 to 5 days prior percutaneous coronary intervention (PCI) and the day of PCI (from 2-4 h pre PCI until 48h post PCI or discharge of patient if earlier)
Title
Plasma concentration of Rivaroxaban
Time Frame
The day of percutaneous coronary intervention (PCI) (from 2 to 4 hours before to 6-8 hours after PCI)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
City
Liege
ZIP/Postal Code
4000
Country
Belgium
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
City
Zwolle
ZIP/Postal Code
8011 JW
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
25925992
Citation
Vranckx P, Leebeek FW, Tijssen JG, Koolen J, Stammen F, Herman JP, de Winter RJ, van T Hof AW, Backx B, Lindeboom W, Kim SY, Kirsch B, van Eickels M, Misselwitz F, Verheugt FW. Peri-procedural use of rivaroxaban in elective percutaneous coronary intervention to treat stable coronary artery disease. The X-PLORER trial. Thromb Haemost. 2015 Aug;114(2):258-67. doi: 10.1160/TH15-01-0061. Epub 2015 Apr 30.
Results Reference
result
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
URL
https://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products

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Exploring the Efficacy and Safety of Rivaroxaban to Support Elective Percutaneous Coronary Intervention

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