Aspirin in the Prevention of Cardiovascular Events in Hemodialysis Patients

NCT01198379 | Withdrawn Phase 4 DMC

• 1 other identifier: BTCGHTN01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End-Stage Renal Disease

Keywords

aspirin; aspirin resistance; hemodialysis; cardiovascular; Prevalence of aspirin resistance, cardiovascular events, and safety profile

Outcome Measures

Primary Outcomes (1)

• the prevalence of aspirin resistance

  3 years

Secondary Outcomes (1)

• the incidence of vascular events (myocardial infarction, cardiac death, stroke, vascular access thrombosis, or revascularization procedure)

  3 years

Study Arms (2)

Aspirin

EXPERIMENTAL

Drug: aspirin

Sugar pills

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

aspirin DRUG

aspirin 100 mg qd for 3 years

Aspirin

Placebo DRUG

Sugar pills

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead
• Taipei Veterans General Hospital, Taiwan: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

  PMID: 35224730 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Der-Cherng Tarng, MD, PhD

  Taipei Veterans General Hospital, Taiwan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: September 10, 2010
• Study Start: February 1, 2010
• Primary Completion: January 15, 2018
• Study Completion: January 15, 2018
• Last Updated: January 17, 2019

Record last verified: 2018-01

Locations

TW (1)