Long-term MOno-Antiplatelet Drug Strategy After PerCutanEous CoronAry InterveNtion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-15

Study Completion Date

2019-11-30

Brief Summary

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The OCEAN (long-term mOn-antiplatelet drug strategy after perCutanEous coronANy intervention) study is the largest prospective multicenter data base to investigate the long-term incidence and prognosis of the use of agents for antiplatelet-induced GI injury symptoms (AI-GIS) or GI hemorrhage among patients undergoing PCI. The OCEAN study will provide evidence of the long-term incidence and prognosis of use of agents for AI-GIS among patients undergoing PCI. It has the potential to provide an optimal long-term mono-antiplatelet strategy.

Detailed Description

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This is a multicenter prospective observational study that will collect data on \>1000 alive patients who have undergone PCI between 1 and 1.5 years prior at 9 hospitals from October 2018. Adult patients (aged ≥18 years) undergoing PCI and prescribed mono-antiplatelet agents (such as aspirin, dihydroxyaluminum aminoacetate-heavy magnesium carbonate-aspirin, and clopidogrel) are eligible for enrollment. In phase 1, patients will be investigated in a cross-sectional manner for the withdrawal rate of dual antiplatelet agents within 1 year after stent implantation. In phase 2, patients will be followed up at 1, 3, and 6 months for AI-GIS and other outcomes. The primary endpoint is AI-GIS (according to the Gastrointestinal Symptom Rating Scale score) or gastrointestinal hemorrhage. Secondary outcomes will include bleeding, antiplatelet replacement/discontinuation, health economic cost, utilization ratio of gastrointestinal-protective drugs, and MACE.

Conditions

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Antiplatelet Drug-related Gastrointestinal Injury

Keywords

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coronary heart disease mono-antiplatelet drug antiplatelet-induced gastrointestinal injury symptom medication adherence prospective observational study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aspirin

Patients(aged ≥18 years) who have undergone PCI between 1 and 1.5 years, currently alive and is using aspirin for mono-antiplatelet therapy.

No interventions assigned to this group

Clopidogrel

Patients(aged ≥18 years) who have undergone PCI between 1 and 1.5 years, currently alive and is using clopidogrel for mono-antiplatelet therapy.

No interventions assigned to this group

ASIDE

Patients(aged ≥18 years) who have undergone PCI between 1 and 1.5 years, currently alive and is using ASIDE for mono-antiplatelet therapy.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years
2. Currently alive at 1-1.5 years after PCI
3. Considered by the physician to be suitable for long-term treatment with mono-antiplatelet agents and is currently using a mono-antiplatelet drug (aspirin, clopidogrel, or dihydroxyaluminum aminoacetate-heavy magnesium carbonate-aspirin \[ASIDE\])
4. Provided written informed consent for this study.

Exclusion Criteria

1. Refusal to sign the informed consent form
2. Acute coronary syndromes
3. Cerebral thrombosis within 1 month or cerebral hemorrhage within 1 year
4. Hematopathy or non-GI bleeding tendency
5. Allergy to aspirin
6. Severe uncontrolled hypertension (\>180/110 mmHg)
7. Pregnancy or lactation
8. Drug or alcohol abuse
9. Malignant tumor or \<1-year life expectancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Liu yong

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yong Liu, MD,PhD

Role: STUDY_DIRECTOR

Guangdong Cardiovascular Institute,Guangdong General Hospital

Shiqun Chen, MS

Role: STUDY_DIRECTOR

Guangdong Cardiovascular Institute,Guangdong General Hospital

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GDREC2018419H

Identifier Type: -

Identifier Source: org_study_id

Long-term MOno-Antiplatelet Drug Strategy After PerCutanEous CoronAry InterveNtion

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Aspirin

Clopidogrel

ASIDE

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou Panyu Central Hospital

First People's Hospital, Shunde China

Second People's Hospital of Foshan City

The First People's Hospital of Qingyuan

Zhongshan People's Hospital, Guangdong, China

Huadu District People's Hospital of Guangzhou

Guangdong Provincial People's Hospital

Responsible Party

Liu yong

Principal Investigators

Yong Liu, MD,PhD

Shiqun Chen, MS

Locations

The First People's Hospital of Shunde

The Second People's Hospital of Foshan

Guangdong General Hospital

Guangzhou Panyu Central Hospital

Huadu District People's Hospital of Guangzhou

The First Affiliated Hospital of Clinical Medicine of Guangdong Pharmaceutical University

Guangdong General Hospital

Qingyuan People's Hospital

Countries

Other Identifiers

GDREC2018419H