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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
108
Unfractionated Heparin: 70-100 IU/Kg bolus and adjusted upon activated coagulation time (ACT) 250 300 seconds
10 mg single dose Rivaroxaban (per os)
20 mg single dose Rivaroxaban (per os)
10 mg single dose Rivaroxaban (per os) followed by bolus 50 IU/Kg unfractionated heparin (UFH)
Unnamed facility
Hasselt, Belgium
Unnamed facility
Liège, Belgium
Unnamed facility
Roeselare, Belgium
Unnamed facility
Amsterdam, Netherlands
Unnamed facility
Amsterdam, Netherlands
Unnamed facility
Eindhoven, Netherlands
Unnamed facility
Zwolle, Netherlands
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
The percentage of subjects who experience an angiographic flow limiting thrombotic event
Time frame: 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
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
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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