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AzTrials

Cardiovascular DiseasePhase 2X-PLORERNCT01442792

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

A Phase 2 study testing UFH, Rivaroxaban (Xarelto, BAY59-7939) and Rivaroxaban (Xarelto, BAY59-7939) and UFH in people with Cardiovascular Disease and Coronary Artery Disease, run by Bayer at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
UFH, Rivaroxaban (Xarelto, BAY59-7939) and Rivaroxaban (Xarelto, BAY59-7939) and UFH
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
7 sitesin 2 countries
Study dates
12 Oct 2011to 4 Mar 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

Netherlands4 sites

  • Study site

    Amsterdam, 1091 AC

  • Study site

    Amsterdam, 1105 AZ

  • Study site

    Eindhoven, 5623 EJ

  • Study site

    Zwolle, 8011 JW

Other trials in Netherlands

Belgium3 sites

  • Study site

    Hasselt, 3500

  • Study site

    Liège, 4000

  • Study site

    Roeselare, 8800

Other trials in Belgium

About this study

Official 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

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.

Being tested
UFH, Rivaroxaban (Xarelto, BAY59-7939), Rivaroxaban (Xarelto, BAY59-7939) and UFH
Keywords
Angioplasty, Balloon, Coronary
Medical subject headings
Cardiovascular Diseases, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UFHDrug

    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)Drug

    20 mg single dose Rivaroxaban (per os)

  • Rivaroxaban (Xarelto, BAY59-7939) and UFHDrug

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

Study groups in NCT01442792
Study groupRoleWhat they receive
Arm 1Active comparatorNot described
Receives: Drug: UFH
Arm 2ExperimentalNot described
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Arm 3ExperimentalNot described
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Arm 4ExperimentalNot described
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) and UFH

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: During the index Percutaneous Coronary Intervention procedure

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

    Measured: During the index Percutaneous Coronary Intervention procedure

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

    Measured: 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

    Measured: During the index Percutaneous Coronary Intervention procedure

Secondary outcomes (10)

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

    Measured: 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

    Measured: Up to 30 days post index Percutaneous coronary intervention procedure

  3. Coagulation profile of Rivaroxaban (Activated Partial Thromboplastin Time)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: The day of percutaneous coronary intervention (PCI) (from 2 to 4 hours before to 6-8 hours after PCI)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2011 (estimated)
  2. Study start12 Oct 2011
  3. Primary completion29 Jan 2013
  4. Study completion4 Mar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01442792
Sponsor's protocol ID
15572
Other IDs
2011-001094-58
Acronym
X-PLORER
Status last verified
Jun 2022
First submitted
18 Aug 2011
Last updated
23 Jun 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25925992

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing UFH, Rivaroxaban (Xarelto, BAY59-7939) and Rivaroxaban (Xarelto, BAY59-7939) and UFH in people with Cardiovascular Disease and Coronary Artery Disease, run by Bayer at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01442792, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.

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