Efficacy and Safety Study of Aspirin for the Prevention of Renal Artery Stenosis in Renal Transplantation Recipients
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 368
- Locations
- 1
- Primary Endpoint
- Incidence of Renal Artery Stenosis
Study Overview
Brief Summary
The anastomotic and peripheral stenosis of the transplanted kidney artery is one of the most important causes of graft failure in renal transplantation. The injury of vascular intima and the formation of microthrombosis may play a significant role in the stenosis of transplanted renal artery of recipients. Inhibiting this process with aspirin may protects against the stenosis of transplanted renal artery.
This is a prospective, randomized, controlled, clinical trial to investigate the efficacy and safety of prevention of renal artery stenosis in recipients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patients with the first renal transplantation were stable;
- •Age ≥ 18 years old;
- •Other anticoagulants and non steroidal anti-inflammatory drugs were not taken at the same time;
- •In the past 3 months, there was no acute cardiovascular and cerebrovascular disease or infection;
- •The rejection of acute and chronic renal transplantation was excluded;
- •The thrombus formation of transplanted kidney was excluded.
Exclusion Criteria
- •Allergic or intolerable to aspirin;
- •Previous transplant history;
- •Take other anticoagulants or non steroidal anti-inflammatory drugs at the same time;
- •History of active gastrointestinal bleeding or severe peptic ulcer;
- •Patients with bleeding tendency or severe liver disease;
- •Cerebral hemorrhage, cerebral infarction or acute infection occurred within 3 months;
- •Acute and chronic rejection;
- •Thrombus formation of transplanted renal vessels;
- •Any condition that increases the risk of adverse events or discontinuation.
Arms & Interventions
Aspirin
Intervention: Aspirin 100mg (Drug)
Placebo (sugar pill)
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Incidence of Renal Artery Stenosis
Time Frame: 2 years
Renal artery stenosis is defined as the presence of post-transplant renal artery stenosis in recipients evaluated by ultrasonography or renal arteriography.
Secondary Outcomes
- Renal Allograft Function(2 years)
- Incidence of Graft Loss(2 years)