Apixaban vs. Enoxaparin bariatric surgery in obese patients

Comparison of Apixaban and Enoxaparin as prophylaxis of venous thromboembolism after one-anastomosis gastric bypass bariatric surgery: a preliminary randomized trial study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220530055031N7

Enrollment

Registered

2024-11-03

Start date

2024-12-21

Completion date

Unknown

Last updated

2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, One-anastomosis gastric bypass surgery. Overweight and obesity

Interventions

Intervention 1: Intervention group: They will receive oral apixaban 5-lepixa (manufactured by Actoverco) from day 2 to day 28 after surgery at a dose of 2.5 mg twice daily. The dosage will be adjusted

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients 18-year-old or older Patients who are a candidate for bariatric surgery with a BMI>40 or BMI>35 with a comorbidity, such as type-2 diabetes or hypertension.

Exclusion criteria

Exclusion criteria: Patients with a prior history of venous thromboembolism. Patients with a prior history of major hemorrhage. Patients who take an anticoagulant agent or NSAIDs, such as Aspirin. Patients with severe hypertension (systolic >200mmHg or diastolic >120 mmHg ). Patients with severe renal diseases (Creatine clearance 2 x normal range). Patients with diseases leading to a hypercoagulable state, i.e. anti-phospholipid ?syndrome, homozygotes for Factor V Leiden deficiency, antithrombin III deficiency, protein C deficiency, Protein S deficiency, hyperhomocystenemia, systemic lupus erythematous. Patients with a prior allergy history to enoxaparin or apixaban.

Design outcomes

Primary

Measure	Time frame
The incidence of venous thromboembolism. Timepoint: On day 12, 28, and 60 post operation. Method of measurement: Clinical examination with Doppler ultrasound, clinical examination with CT scan.;Plasma level of anti-Xa. Timepoint: On day 3-5 post surgery. Method of measurement: anti-Xa factor assay.	—

Secondary

Measure	Time frame
The incidence of major bleeding. Timepoint: day 12, 28, and 60 post operation. Method of measurement: It is measured according to the definition in clinical evaluations.;Patients' satisfaction and quality of life. Timepoint: day 12, 28, and 60 post operation. Method of measurement: SF-8 score questionnaire.;Compliance (number of days in which the patient took the medication). Timepoint: day 12, 28, and 60 post operation. Method of measurement: History and delivery of empty containers during visits.	—

Measure

Time frame

The incidence of major bleeding. Timepoint: day 12, 28, and 60 post operation. Method of measurement: It is measured according to the definition in clinical evaluations.;Patients' satisfaction and quality of life. Timepoint: day 12, 28, and 60 post operation. Method of measurement: SF-8 score questionnaire.;Compliance (number of days in which the patient took the medication). Timepoint: day 12, 28, and 60 post operation. Method of measurement: History and delivery of empty containers during visits.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Amir Miratashi Yazdi

Tehran University of Medical Sciences

amiratashi@tums.ac.ir+98 21 6634 8500

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026