## Protocol Section
### Identification Module
**NCT ID:** NCT01198379

**Brief Title:** Aspirin in the Prevention of Cardiovascular Events in Hemodialysis Patients

**Official Title:** Efficacy of Monitoring of Aspirin Responsiveness in the Prevention of Cardiovascular Events and Decrease in Bleeding Complications in Patients With End-Stage Kidney Disease Undergoing Hemodialysis

#### Organization Study ID Info
**ID:** BTCGHTN01
#### Organization
**Class:** OTHER
**Full Name:** Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
### Status Module
#### Completion Date
**Date:** 2018-01-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-01-17

**Type:** ACTUAL

**Last Update Submit Date:** 2019-01-15

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2018-01-15

**Type:** ACTUAL

#### Start Date
**Date:** 2010-02

**Type:** ESTIMATED

**Status Verified Date:** 2018-01

#### Study First Post Date
**Date:** 2010-09-10
**Type:** ESTIMATED
**Study First Submit Date:** 2010-08-24
**Study First Submit QC Date:** 2010-09-08
**Why Stopped:** No participants enrolled
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Taipei Veterans General Hospital, Taiwan

#### Lead Sponsor

**Class:** OTHER

**Name:** Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- End-Stage Renal Disease

**Keywords:**

- aspirin

- aspirin resistance

- hemodialysis

- cardiovascular

- Prevalence of aspirin resistance, cardiovascular events, and safety profile

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: aspirin

**Label:** Aspirin

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Drug: Placebo

**Label:** Sugar pills

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Aspirin

**Description:** aspirin 100 mg qd for 3 years

**Name:** aspirin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Sugar pills

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** the prevalence of aspirin resistance

**Time Frame:** 3 years

#### Secondary Outcomes

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

**Time Frame:** 3 years

### Eligibility Module

**Eligibility Criteria:** 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).

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Taipei

**Country:** Taiwan

**Facility:** Taipei Veterans General Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Taipei Veterans General Hospital, Taiwan

**Name:** Der-Cherng Tarng, MD, PhD

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** 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 Section

### Condition Browse Module - Ancestors

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000051436

- Term: Renal Insufficiency, Chronic

- ID: D000051437

- Term: Renal Insufficiency

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: LOW

- As Found: Unknown

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10699

- Name: Kidney Failure, Chronic

- Relevance: HIGH

- As Found: End Stage Renal Disease

- ID: M26718

- Name: Renal Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007676

- Term: Kidney Failure, Chronic

### Intervention Browse Module - Ancestors

- ID: D000000894

- Term: Anti-Inflammatory Agents, Non-Steroidal

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000005343

- Term: Fibrinolytic Agents

- ID: D000050299

- Term: Fibrin Modulating Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000010975

- Term: Platelet Aggregation Inhibitors

- ID: D000016861

- Term: Cyclooxygenase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000058633

- Term: Antipyretics

### Intervention Browse Module - Browse Branches

- Abbrev: Antipy

- Name: Antipyretics

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: FiAg

- Name: Fibrinolytic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: PlAggInh

- Name: Platelet Aggregation Inhibitors

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4548

- Name: Aspirin

- Relevance: HIGH

- As Found: Progression

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4218

- Name: Anti-Inflammatory Agents, Non-Steroidal

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M8473

- Name: Fibrinolytic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M13865

- Name: Platelet Aggregation Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M19209

- Name: Cyclooxygenase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M29176

- Name: Antipyretics

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000001241

- Term: Aspirin

### Misc Info Module

- Version Holder: 2024-05-24
