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Completed

NCT Number: NCT01442792

Exploring the Efficacy and Safety of Rivaroxaban 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.

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Key information

Conditions

Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hasselt, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UFH

Drug

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

Rivaroxaban (Xarelto, BAY59-7939)

Drug

10 mg single dose Rivaroxaban (per os)

Rivaroxaban (Xarelto, BAY59-7939) and UFH

Drug

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

Primary outcomes

  1. 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

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

    Time frame: During the index Percutaneous Coronary Intervention procedure

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

    Time frame: During the index Percutaneous Coronary Intervention procedure

  4. 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 outcomes

  1. 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

  2. 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

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study 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

Acronym: X-PLORER

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 29, 2011
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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