Long-term MOno-Antiplatelet Drug Strategy After PerCutanEous CoronAry InterveNtion (RESCIND-OCEAN)

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Unknown

Conditions: Antiplatelet Drug-related Gastrointestinal Injury

Study type: Observational

Funder types: Other

Identifiers

NCT03725800

GDREC2018419H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 3 patient groups

Aspirin

Description:

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

Clopidogrel

Description:

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

ASIDE

Description:

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