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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01442792
First received: August 18, 2011
Last updated: April 1, 2014
Last verified: April 2014
  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.


Condition Intervention Phase
Cardiovascular Disease, Coronary Artery Disease
Drug: UFH
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Drug: Rivaroxaban (Xarelto, BAY59-7939) and UFH
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • The percentage of subjects who experience an angiographic flow limiting thrombotic event [ Time Frame: During the index Percutaneous Coronary Intervention procedure ] [ Designated as safety issue: No ]
  • The percentage of subjects who experience thrombus formation on the Percutaneous Coronary Intervention equipment [ Time Frame: During the index Percutaneous Coronary Intervention procedure ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: October 2011
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 Drug: UFH
Unfractionated Heparin: 70-100 IU/Kg bolus and adjusted upon activated coagulation time (ACT) 250 300 seconds
Experimental: Arm 2 Drug: Rivaroxaban (Xarelto, BAY59-7939)
10 mg single dose Rivaroxaban (per os)
Experimental: Arm 3 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442792

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
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01442792     History of Changes
Other Study ID Numbers: 15572, 2011-001094-58
Study First Received: August 18, 2011
Last Updated: April 1, 2014
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Bayer:
Angioplasty, Balloon, Coronary

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Rivaroxaban
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014