Clinical trial NCT03725800: Long-term MOno-Antiplatelet Drug Strategy After PerCutanEous CoronAry InterveNtion
Official title: Rationale and Design of the OCEAN Study (Long-term mOno-antiplatelet Drug Strategy After perCutanEous coronAry interveNtion), A Multicenter, Prospective, Registered Branch of the RESCIND Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antiplatelet Drug-related Gastrointestinal Injury
Keywords: coronary heart disease
mono-antiplatelet drug
antiplatelet-induced gastrointestinal injury symptom
medication adherence
prospective observational study
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: The First Affiliated Hospital of Guangdong Pharmaceutical University
name: Guangzhou Panyu Central Hospital
name: First People's Hospital, Shunde China
name: Second People's Hospital of Foshan City
name: The First People's Hospital of Qingyuan
name: Zhongshan People's Hospital, Guangdong, China
name: Huadu District People's Hospital of Guangzhou
First posted: 2018-10-31
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: OCEAN study is a multicenter, prospective, observational study. The study population will consist of 1000 patients. It will be conducted in 9 centers in China.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Antiplatelet-induced Gastrointestinal Injury Symptom(AI-GIS)
timeFrame: 1 year after PCI
Secondary outcomes:
measure: Bleeding Events
timeFrame: 1-1.5 years after PCI
measure: Conversion of Antiplatelet Drug
timeFrame: 1-1.5 years after PCI
measure: Discontinuation of Antiplatelet Drug
timeFrame: 1-1.5 years after PCI
measure: Health Economic Costs
timeFrame: 1-1.5 years after PCI
measure: Utilization Rate of GI Protection Drug
timeFrame: 1-1.5 years after PCI
measure: Major Adverse Cardiovascular Events
timeFrame: 1-1.5 years after PCI
Other outcomes:
Locations:
city: Foshan
country: China
facility: The First People's Hospital of Shunde
state: Guangdong
city: Foshan
country: China
facility: The Second People's Hospital of Foshan
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Panyu Central Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Huadu District People's Hospital of Guangzhou
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Clinical Medicine of Guangdong Pharmaceutical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Qingyuan
country: China
facility: Qingyuan People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Cardiovascular Institute,Guangdong General Hospital
name: Yong Liu, MD,PhD
role: STUDY_DIRECTOR
affiliation: Guangdong Cardiovascular Institute,Guangdong General Hospital
name: Shiqun Chen, MS
role: STUDY_DIRECTOR
References: