NCT01442792

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_2

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 29, 2011

Completed
13 days until next milestone

Study Start

First participant enrolled

October 12, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2013

Completed
Last Updated

June 23, 2022

Status Verified

June 1, 2022

Enrollment Period

1.3 years

First QC Date

August 18, 2011

Last Update Submit

June 20, 2022

Conditions

Cardiovascular DiseaseCoronary Artery Disease

Keywords

Angioplasty, Balloon, Coronary

Outcome Measures

Primary Outcomes (4)

  • The percentage of subjects who require bail-out anticoagulant therapy in the context of an ischemic coronary event

    During the index Percutaneous Coronary Intervention procedure

  • The percentage of subjects who experience an angiographic flow limiting thrombotic event

    During the index Percutaneous Coronary Intervention procedure

  • The percentage of subjects who experience thrombus formation on the Percutaneous Coronary Intervention equipment

    During the index Percutaneous Coronary Intervention procedure

  • The percentage of subjects who experience an Myocardial Infarction due to the Percutaneous Coronary Intervention equipment procedure

    During the index Percutaneous Coronary Intervention procedure

Secondary Outcomes (10)

  • Bleeding (Thrombolysis in Myocardial Infarction major, minor and Bleeding academic research consortium type 2, 3 and 5)

    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

    Up to 30 days post index Percutaneous coronary intervention procedure

  • Coagulation profile of Rivaroxaban (Activated Partial Thromboplastin Time)

    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)

    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)

    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)

  • +5 more secondary outcomes

Study Arms (4)

Arm 1

ACTIVE COMPARATOR
Drug: UFH

Arm 2

EXPERIMENTAL
Drug: Rivaroxaban (Xarelto, BAY59-7939)

Arm 3

EXPERIMENTAL
Drug: Rivaroxaban (Xarelto, BAY59-7939)

Arm 4

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

Interventions

UFHDRUG

Unfractionated Heparin: 70-100 IU/Kg bolus and adjusted upon activated coagulation time (ACT) 250 300 seconds

Arm 1
Rivaroxaban (Xarelto, BAY59-7939)DRUG

10 mg single dose Rivaroxaban (per os)

Arm 2
Rivaroxaban (Xarelto, BAY59-7939) and UFHDRUG

10 mg single dose Rivaroxaban (per os) followed by bolus 50 IU/Kg unfractionated heparin (UFH)

Arm 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Hasselt, 3500, Belgium

Location

Unknown Facility

Liège, 4000, Belgium

Location

Unknown Facility

Roeselare, 8800, Belgium

Location

Unknown Facility

Amsterdam, 1091 AC, Netherlands

Location

Unknown Facility

Amsterdam, 1105 AZ, Netherlands

Location

Unknown Facility

Eindhoven, 5623 EJ, Netherlands

Location

Unknown Facility

Zwolle, 8011 JW, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 25925992RESULT

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary Artery Disease

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2011

First Posted

September 29, 2011

Study Start

October 12, 2011

Primary Completion

January 29, 2013

Study Completion

March 4, 2013

Last Updated

June 23, 2022

Record last verified: 2022-06

Locations

BE(3)NL(4)