Rivaroxaban - 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

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-03-01

Brief Summary

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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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Detailed Description

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Conditions

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Coronary Artery Disease Atrial Fibrillation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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control group

five healthy adults

In vitro heparin

Intervention Type DRUG

In vitro heparin and in vitro LMWH

Study group

Twenty-five patients using the direct oral factor Xa inhibitor rivaroxaban

In vitro heparin

Intervention Type DRUG

In vitro heparin and in vitro LMWH

Interventions

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In vitro heparin

In vitro heparin and in vitro LMWH

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No