check_circleStudy Completed

Cardiovascular Disease, Coronary Artery Disease

Bayer Identifier:

15572

ClinicalTrials.gov Identifier:

NCT01442792

EudraCT Number:

2011-001094-58

EU CT Number:

Not Available
Exploring the efficacy and safety of Rivaroxaban to support elective percutaneous coronary intervention

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
108
Trial Dates
October 2011 - March 2013
Phase
Phase 2
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
LIEGE, 4000, Belgium
Completed
HASSELT, 3500, Belgium
Completed
AMSTERDAM, 1091 AC, Netherlands
Completed
EINDHOVEN, 5623 EJ, Netherlands
Completed
ZWOLLE, 8011 JW, Netherlands
Completed
AMSTERDAM, 1105 AZ, Netherlands
Completed
ROESELARE, 8800, Belgium

Primary Outcome

  • The percentage of subjects who require bail-out anticoagulant therapy in the context of an ischemic coronary event
    date_rangeTime Frame:
    During the index Percutaneous Coronary Intervention procedure
    enhanced_encryption
    Safety Issue:
    No
  • The percentage of subjects who experience an angiographic flow limiting thrombotic event
    date_rangeTime Frame:
    During the index Percutaneous Coronary Intervention procedure
    enhanced_encryption
    Safety Issue:
    No
  • The percentage of subjects who experience thrombus formation on the Percutaneous Coronary Intervention equipment
    date_rangeTime Frame:
    During the index Percutaneous Coronary Intervention procedure
    enhanced_encryption
    Safety Issue:
    No
  • The percentage of subjects who experience an Myocardial Infarction due to the Percutaneous Coronary Intervention equipment procedure
    date_rangeTime Frame:
    During the index Percutaneous Coronary Intervention procedure
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Bleeding (Thrombolysis in Myocardial Infarction major, minor and Bleeding academic research consortium type 2, 3 and 5)
    date_rangeTime Frame:
    Up to 30 days post index Percutaneous coronary intervention procedure
    enhanced_encryption
    Safety Issue:
    Yes
  • Composite of clinical ischemic events (all death, non-fatal Myocardial Infarction, non-fatal stroke and target lesion revascularization
    date_rangeTime Frame:
    Up to 30 days post index Percutaneous coronary intervention procedure
    enhanced_encryption
    Safety Issue:
    Yes
  • Coagulation profile of Rivaroxaban (Activated Partial Thromboplastin Time)
    date_rangeTime 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)
    enhanced_encryption
    Safety Issue:
    No
  • Coagulation profile of Rivaroxaban (Prothrombin time)
    date_rangeTime 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)
    enhanced_encryption
    Safety Issue:
    No
  • Coagulation profile of Rivaroxaban (Thrombin Time)
    date_rangeTime 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)
    enhanced_encryption
    Safety Issue:
    No
  • Coagulation profile of Rivaroxaban (Prothrombin Fragment 1+2)
    date_rangeTime 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)
    enhanced_encryption
    Safety Issue:
    No
  • Coagulation profile of Rivaroxaban (Thrombin Anti-thrombin III Complexes)
    date_rangeTime 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)
    enhanced_encryption
    Safety Issue:
    No
  • Coagulation profile of Rivaroxaban (Anti-Xa Activity)
    date_rangeTime 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)
    enhanced_encryption
    Safety Issue:
    No
  • Coagulation profile of Rivaroxaban (endogenous thrombin potential)
    date_rangeTime 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)
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Rivaroxaban
    date_rangeTime Frame:
    The day of percutaneous coronary intervention (PCI) (from 2 to 4 hours before to 6-8 hours after PCI)
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

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