## Protocol Section
### Identification Module
**NCT ID:** NCT06428110

**Brief Title:** A Prospective Cohort Study on Warfarin Personalized Medication

**Official Title:** Personalized Medication Research of Warfarin Based on Vascular Aging Assessment

#### Organization Study ID Info
**ID:** 2020081
#### Organization
**Class:** OTHER
**Full Name:** Shanghai 5th People's Hospital
### Status Module
#### Completion Date
**Date:** 2023-12-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-12

**Type:** ACTUAL

#### Start Date
**Date:** 2021-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Haobin Li

#### Responsible Party

**Investigator Affiliation:** Shanghai 5th People's Hospital

**Investigator Full Name:** Haobin Li

**Investigator Title:** Principal Investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Analyze the impact of the degree of blood vessel aging on the anticoagulant effect and bleeding risk of warfarin. Evaluating the possibility of using the degree of blood vessel aging to guide individualized use of the anticoagulant drug warfarin.

### Conditions Module

**Conditions:**

- Warfarin Sodium Causing Adverse Effects in Therapeutic Use

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 272

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Label:** Patients taking warfarin with vascular aging group

#### Arm Group 2

**Label:** Patients taking warfarin with normal vascular group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients taking warfarin with normal vascular group

- Patients taking warfarin with vascular aging group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Numbers of patients with bleeding events during warfarin treatment

**Measure:** Numbers of patients with bleeding events

**Time Frame:** 1 year during the follow-up

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients aged 65 years and older, taking warfarin, with or without premature vascular aging, regardless of gender.

  * Patients who have not concurrently or intermittently used anticoagulant drugs, including antiplatelet drugs, heparin, low molecular weight heparin, and non-vitamin K-dependent oral anticoagulants, such as dabigatran and apixaban.

    * Signing an informed consent form before blood sample collection.

Exclusion Criteria:

* Patients who are allergic to warfarin or lactose.

  * Patients who are receiving immunosuppressive agents or low molecular weight heparin anticoagulants.

    * Patients with bleeding tendencies, blood disorders with platelet counts \> 400 × 10\^9 /L or \< 100 × 10\^9 /L, hemoglobin \> 169 or \< 100 g/L.

      * History of peptic ulcer disease.

        * Malignant tumors, severe multi-organ dysfunction or failure such as heart, liver, and kidney.

          * Neurological disorders such as epilepsy.

**Maximum Age:** 100 Years

**Minimum Age:** 65 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

**Study Population:** Patients taking warfarin

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Shanghai

**Country:** China

**Facility:** The Fifth People's Hospital of Shanghai

**State:** Shanghai

**Zip:** 200240

#### Overall Officials

**Official 1:**

**Affiliation:** The Fifth People's Hospital of Shanghai

**Name:** Guangchun Sun

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: AnCoag

- Name: Anticoagulants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17602

- Name: Warfarin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
