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Completed

NCT Number: NCT05541757

Rivaroxaban - Percutaneous Coronary Intervention

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.

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Key information

Conditions

Coronary Artery Disease Arrhythmias, Cardiac Arterial Occlusive Diseases Arteriosclerosis Atrial Fibrillation Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

In vitro heparin

Drug

In vitro heparin and in vitro LMWH

Primary outcomes

  1. Anticoagulation level

    Time frame: 4 - 12 hours

    anti-factor Xa

Sponsors and collaborators

Lead sponsor

Bursa Postgraduate Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 15, 2022
Registry last updated
Sep 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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