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Evaluating the efficacy and safety of rivaroxaban comparing to warfarin in patients with chronic thromboembolic pulmonary hypertension (CTEPH) following endartrectomy surgery

Evaluating the efficacy and safety of rivaroxaban comparing to warfarin in patients with chronic thromboembolic pulmonary hypertension (CTEPH) following endartrectomy surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20151227025726N22
Enrollment
96
Registered
2020-10-07
Start date
2019-10-08
Completion date
Unknown
Last updated
2020-11-09

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

Conditions

Chronic Thrombo Embolic Pulmonary Hypertension(CTEPH). Chronic Thromboembolic Pulmonary Hypertension.

Interventions

Intervention 1: Intervention group: For the intervention group, rivaroxaban was prescribed at a dose of 15 mg twice a day for 21 days and then 20 mg once a day.In the study, Rivaoxaban made by Dr. Abi

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients undergoing endarterectomy following chronic thromboembolic pulmonary hypertension at Masih Daneshvari Hospital.

Exclusion criteria

Exclusion criteria: Any allergies to the prescribed medication Any bleeding includes active gastrointestinal, pulmonary, genitourinary bleeding Cerebral aneurysm Intracranial bleeding Aneurysm and aortic dissection A patient undergoing spinal puncture Blood dyscrasia Uncontrolled blood pressure (110/180 mmHg <pressure) Inflammation and pericardial effusion Bacterial endocarditis Pregnancy and lactation Liver disease(child pugh B&C) GFR<30 mL/min Any coagulation disorder If the patient has been prescribed strong Cyp450 and Pgp inhibitors such as ketoconazole, itraconazole, posaconazole and ritonavir.

Design outcomes

Primary

MeasureTime frame
Recurrence of thrombosis. Timepoint: Patients are evaluated at one, three and six months after surgery. Method of measurement: Medical record.;Incidence of ischemic and hemorrhagic stroke. Timepoint: Patients are evaluated at one, three and six months after surgery. Method of measurement: Medical record.

Secondary

MeasureTime frame
Incidence of bleeding. Timepoint: Patients are evaluated at intervals of one, three and six months after surgery. Method of measurement: Medical record.;Patient readmission. Timepoint: Patients are evaluated at intervals of one, three and six months after surgery. Method of measurement: Medical record.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Amini Ebrahimabad

Shahid Beheshti University of Medical Sciences

Hosseinamini96@yahoo.com+98 21 8820 0118

Outcome results

None listed

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