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

June 20, 2022 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Hasselt, Belgium, 3500
      • Liege, Belgium, 4000
      • Roeselare, Belgium, 8800
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
      • Amsterdam, Netherlands, 1091 AC
      • Eindhoven, Netherlands, 5623 EJ
      • Zwolle, Netherlands, 8011 JW

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 2
Drug: Rivaroxaban (Xarelto, BAY59-7939)
10 mg single dose Rivaroxaban (per os)
Drug: Rivaroxaban (Xarelto, BAY59-7939)
20 mg single dose Rivaroxaban (per os)
Experimental: Arm 3
Drug: Rivaroxaban (Xarelto, BAY59-7939)
10 mg single dose Rivaroxaban (per os)
Drug: Rivaroxaban (Xarelto, BAY59-7939)
20 mg single dose Rivaroxaban (per os)
Experimental: Arm 4
Drug: Rivaroxaban (Xarelto, BAY59-7939) and UFH
10 mg single dose Rivaroxaban (per os) followed by bolus 50 IU/Kg unfractionated heparin (UFH)
Active Comparator: Arm 1
Drug: UFH
Unfractionated Heparin: 70-100 IU/Kg bolus and adjusted upon activated coagulation time (ACT) 250 300 seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
During the index Percutaneous Coronary Intervention procedure
The percentage of subjects who experience an angiographic flow limiting thrombotic event
Time Frame: During the index Percutaneous Coronary Intervention procedure
During the index Percutaneous Coronary Intervention procedure
The percentage of subjects who experience thrombus formation on the Percutaneous Coronary Intervention equipment
Time Frame: During the index Percutaneous Coronary Intervention procedure
During the index Percutaneous Coronary Intervention procedure
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
During the index Percutaneous Coronary Intervention procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Up to 30 days post index Percutaneous coronary intervention procedure
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
Up to 30 days post index Percutaneous coronary intervention procedure
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
The day of percutaneous coronary intervention (PCI) (from 2 to 4 hours before to 6-8 hours after PCI)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2011

Primary Completion (Actual)

January 29, 2013

Study Completion (Actual)

March 4, 2013

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (Estimate)

September 29, 2011

Study Record Updates

Last Update Posted (Actual)

June 23, 2022

Last Update Submitted That Met QC Criteria

June 20, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15572
  • 2011-001094-58 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on UFH

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe