Rivaroxaban - Percutaneous Coronary Intervention

September 13, 2022 updated by: Hasan ARI, Bursa Postgraduate Hospital

In-Vitro Evaluation of Anticoagulant Therapy Management When Urgent Percutaneous Coronary Intervention is Required in Rivaroxaban-Treated Patients

We investigated in-vitro the management of intraprocedural anticoagulation in patients requiring immediate percutaneous coronary intervention(PCI) while using regular direct oral anticoagulants(DOACs). Twenty-five patients taking 20mg of rivaroxaban once daily comprised the study group, while five healthy volunteers included the control group. In study group, a beginning(24-hours after the last rivaroxaban dose) examination was performed. Then, the effects of basal and four different anticoagulant doses(50IU/kg unfractionated heparin(UFH), 100IU/kg UFH, 0.5mg/kg enoxaparin, and 1mg/kg enoxaparin) on coagulation parameters were investigated at the 4th and 12th hours following rivaroxaban intake. Anticoagulant activity was assessed mainly by anti-factor Xa(anti-Xa) levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey
        • Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with persistent or permanent AF had been using rivaroxaban 20 mg daily for at least one month

Description

Inclusion Criteria:

  • patients using the direct oral factor Xa inhibitor rivaroxaban
  • Atrial fibrillation

Exclusion Criteria:

  • malignancy,
  • coagulopathy,
  • heart valve disease,
  • active infection,
  • chronic systemic or inflammatory disease,
  • recent ACS or elective PCI,
  • uncontrolled hypertension and diabetes,
  • cerebrovascular accident,
  • thyroid disorder,
  • left ventricular systolic dysfunction (ejection fraction <50%),
  • glomerular filtration rate <50 mL/min/1.73 m2,
  • underweight and overweight (<60 kg and >100 kg),
  • age >75 years,
  • hyperbilirubinemia and hypertriglyceridemia (>350 mg/dl).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control group
five healthy adults
Drug: In vitro heparin
In vitro heparin and in vitro LMWH
Study group
Twenty-five patients using the direct oral factor Xa inhibitor rivaroxaban
Drug: In vitro heparin
In vitro heparin and in vitro LMWH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anticoagulation level
Time Frame: 4 - 12 hours
anti-factor Xa
4 - 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa Postgraduate Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2021

Primary Completion (ACTUAL)

January 1, 2022

Study Completion (ACTUAL)

March 1, 2022

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (ACTUAL)

September 15, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BYİEAH4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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