Exploring the Efficacy and Safety of Rivaroxaban to Support Elective Percutaneous Coronary Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-12

Study Completion Date

2013-03-04

Brief Summary

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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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Detailed Description

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Conditions

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Cardiovascular Disease Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type ACTIVE_COMPARATOR

UFH

Intervention Type DRUG

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

Arm 2

Group Type EXPERIMENTAL

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

10 mg single dose Rivaroxaban (per os)

Arm 3

Group Type EXPERIMENTAL

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

20 mg single dose Rivaroxaban (per os)

Arm 4

Group Type EXPERIMENTAL

Rivaroxaban (Xarelto, BAY59-7939) and UFH

Intervention Type DRUG

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

Interventions

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UFH

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

Intervention Type DRUG

Rivaroxaban (Xarelto, BAY59-7939)

10 mg single dose Rivaroxaban (per os)

Intervention Type DRUG

Rivaroxaban (Xarelto, BAY59-7939)

20 mg single dose Rivaroxaban (per os)

Intervention Type DRUG

Rivaroxaban (Xarelto, BAY59-7939) and UFH

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No