## Protocol Section
### Identification Module
**NCT ID:** NCT03353779

**Brief Title:** The Impact Of Platelet Function on 1-year Outcome in Complex PCI Patients

**Official Title:** The Impact Of Platelet Function on 1-year Outcome in Complex PCI Patients

#### Organization Study ID Info
**ID:** 2017-901
#### Organization
**Class:** OTHER
**Full Name:** Chinese Academy of Medical Sciences, Fuwai Hospital
### Status Module
#### Completion Date
**Date:** 2021-07-29

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2018-01-25

**Type:** ACTUAL

**Last Update Submit Date:** 2018-01-24

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-07-29

**Type:** ESTIMATED

#### Start Date
**Date:** 2017-11-29

**Type:** ACTUAL

**Status Verified Date:** 2018-01

#### Study First Post Date
**Date:** 2017-11-27
**Type:** ACTUAL
**Study First Submit Date:** 2017-11-20
**Study First Submit QC Date:** 2017-11-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Chinese Academy of Medical Sciences, Fuwai Hospital

#### Responsible Party

**Investigator Affiliation:** Chinese Academy of Medical Sciences, Fuwai Hospital

**Investigator Full Name:** Yi-Da Tang

**Investigator Title:** Professor, Chief Physician

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** To identify the optimal cut-off values in different platelet function testing to predict MACCE at 12-months in complex PCI patients of China

**Detailed Description:** This study will observe the relationship between platelet function testing and clinical outcomes. Meanwhile we aim to identify optimal cut-off values in different platelet function testing, including IPF, TEG and VerifyNow, to predict MACCE during12-months in complex PCI patients.

### Conditions Module

**Conditions:**

- Percutaneous Coronary Intervention

- Coronary Artery Disease

**Keywords:**

- Percutaneous coronary intervention

- antiplatelet

- platelet function

- prognosis

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1440

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Optimal cut-off values in different platelet function testing to predict MACCE at 12-months in complex PCI patients of China

**Time Frame:** Within 12 months of patient enrolled

#### Secondary Outcomes

**Measure:** Effectiveness and sensitivity of predicting between different platelet function testing

**Time Frame:** Within 12 months of patient enrolled

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Documented undergoing complex PCI in 1 year prior to enrollment.

Exclusion Criteria:

* Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language where interpreter services are not reliably available, psychiatric disturbances, alcohol or drug abuse).
* Presence of serious/severe co-morbidities in the opinion of the investigator which may limit life expectancy (\<1 year).
* Current participation in a blinded randomized clinical trial.

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Patients with complex PCI were defined as having at least 1of the following features :3 vessels treated,≥3 stents implanted, ≥3 lesions treated,bifurcation with 2stents implanted ,total stent length \>60 mm or chronic total occlusion.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** chunlishao@126.com

**Name:** Chunli Shao, MD

**Phone:** +861088396171

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Name:** Chunli Shao, MD, PhD

- **Phone:** +861088396171

- **Role:** CONTACT

**Country:** China

**Facility:** Chinese Academy of Medical Sciences Fuwai Hospital

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100037

#### Overall Officials

**Official 1:**

**Affiliation:** Chinese Academy of Medical Sciences, Fuwai Hospital

**Name:** Yida Tang, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003327

- Term: Coronary Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6549

- Name: Coronary Disease

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery Disease

### Misc Info Module

- Version Holder: 2024-05-24
