Aspirin in the Prevention of Cardiovascular Events in Hemodialysis Patients

Buddhist Tzu Chi Medical Foundation

Status and phase: Withdrawn; Phase 4

Conditions: End-Stage Renal Disease

Treatments: Drug: aspirin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01198379

BTCGHTN01

Details and patient eligibility

About

The study is prospectively initiated to: (1) evaluate the alterations in platelet function to aspirin therapy and the prevalence of aspirin resistance in patients with chronic kidney disease undergoing hemodialysis, and (2) compare the incidence of vascular events (myocardial infarction, cardiac death, stroke, vascular access thrombosis, or revascularization procedure) and the safety profile among placebo-treated, aspirin-resistant and aspirin-sensitive patients.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with end-stage renal disease who are undergoing long-term hemodialysis.

Exclusion criteria

Patients will be excluded if there is evidence of

• a recent history of acute uremia,
• previous adverse reaction to a aspirin or history of aspirin hypersensitivity (eg, aspirin-induced asthma or angioedema),
• concurrent treatment with other antiplatelet agent (clopidogrel or ticlopidine), steroidal drugs, or nonsteroidal anti-inflammatory drugs,
• high immediate risk for bleeding (eg, active peptic ulceration, recent injury, or hemophilia), or
• life-threatening condition other than end-stage renal disease or vascular disease (eg, non-skin cancer).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Aspirin

Experimental group

Treatment:

Drug: aspirin

Sugar pills

Placebo Comparator group

Description:

Hemodialysis (HD) patients receive placebo not containing aspirin in this study.

Treatment:

Drug: Placebo