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Safety and efficacy of antiplatelet combined with rivaroxaban therapy vs dual-antiplatelet therapy in patients after percutaneous pulmonary angioplasty: a randomized multicenter, open-label trial.

Safety and efficacy of antiplatelet combined with rivaroxaban therapy vs dual-antiplatelet therapy in patients after percutaneous pulmonary angioplasty: a randomized multicenter, open-label trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086188
Enrollment
Unknown
Registered
2024-06-26
Start date
2024-07-15
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

pulmonary artery stenosis/pulmonary vein stenosis

Interventions

dual-antiplatelet therapy group:dual-antiplatelet
antiplatelet combined with rivaroxaban group:antiplatelet combined with rivaroxaban

Sponsors

Gansu Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age =18 years or =75 years; 2.Performed percutaneous pulmonary angioplasty; 3.Subjects without known contraindication to dual antiplatelet therapy for at least 30 months after enrollment and stent implantation; 4.The subject had consented to participate and had authorized the collection and release of his medical information by signing the "Patient Informed Consent Form". The informed consent was valid for the duration of the trial or until the subject withdrew.

Exclusion criteria

Exclusion criteria: 1.Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy. 2.Planned surgery necessitating discontinuation of antiplatelet therapy (>14 days) within the 30 months following enrollment. 3.Patients with abnormal coagulation function or previously diagnosed hematological disorders. 4.Concurrent medical condition with a life expectancy of less than 2 years. 5.Participating in other clinical trials. 6.Estimated glomerular filtration rate <15 mL/min. 7.Any known hepatic disease associated with coagulopathy. 8.History of intracranial hemorrhage or subdural hematoma. 9.Routine use of oral non-steroidal anti-inflammatory drugs (NSAID).

Design outcomes

Primary

MeasureTime frame
survival;Incidence of bleeding events;Cardio-cerebrovascular accident;in-stent stenosis;

Secondary

MeasureTime frame
in-stent thrombosis;

Countries

China

Contacts

Public ContactYunshan Cao

Gansu Provincial Hospital

yunshancao@126.com+86 136 6930 6699

Outcome results

None listed

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