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

• Conditions: Antiplatelet Drug-related Gastrointestinal Injury

• Registration Number: NCT03725800
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-10-15
• Study First Submitted: 2018-10-27
• Study First Submitted QC: 2018-10-30
• Last Update Submitted: 2018-10-30
• Study First Posted: 2018-10-31
• Last Update Posted: 2018-10-31
• Primary Completion: 2019-10
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antiplatelet-induced Gastrointestinal Injury Symptom(AI-GIS)	1 year after PCI	AI-GIS was estimated according to the Gastrointestinal Symptom Rating Scale(GSRS). This scale included a total of 15 evaluation indicators(Abdominal pains、Heartburn、Acid regurgitation、Sucking sensations in the epigastrium、Nausea and vomiting、Borborygmus、Abdominal distension、Eructation、Increased flatus、Decreased passage of stools、Increased passage of stools、Loose stools、Hard Stools、Urgent need for defecation、Feeling of incomplete evacuation）. The score for each indicator was determined by intensity, frequency, duration, request for relief, and impact on social performance. A score of 0 indicated no or only transient symptoms. A score of 3 indicated continuous discomfort with impact on all social activities. The total minimum score was 0 points and the total maximum score was 45 points. Higher score represented a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Health Economic Costs	1-1.5 years after PCI	Health economic costs included the following 3 parts: 1) cost of each of the 3 antiplatelet drugs; 2) cost of each of the 3 antiplatelet drugs plus PPI; and 3) total prescription cost provided at each follow-up time.
Utilization Rate of GI Protection Drug	1-1.5 years after PCI	Utilization rate of GI protection drug included brief (1-7 days), temporary (8-30 days), or permanent (\>30 days) utilization of PPI, H2RA, sucralfate, or prostaglandins, according to the continued utilization duration within 1 year after drug-coated stent implantation.
Conversion of Antiplatelet Drug	1-1.5 years after PCI	Conversion of antiplatelet drug included brief (1-7 days), temporary (8-30 days), or permanent (\>30 days) conversion, according to the continued conversion duration within 1 year after drug-coated stent implantation.
Discontinuation of Antiplatelet Drug	1-1.5 years after PCI	Discontinuation of antiplatelet drug included brief (1-7 days), temporary (8-30 days), or permanent (\>30 days) discontinuation, according to the continued discontinuation duration within 1 year after drug-coated stent implantation.
Major Adverse Cardiovascular Events	1-1.5 years after PCI	All-cause mortality, target vessel revascularization, and non-fatal myocardial infarction (at 3 and 6 months)
Bleeding Events	1-1.5 years after PCI	It was estimated according to Thrombolysis in Myocardial Infarction \[TIMI\] score. This score included two categories: Major bleeding and Minor bleeding. The Major bleeding was defined as: Intracranial or clinically significant overt signs of hemorrhage associated with a greater than 50 g/L decrease in hemoglobin level or an absolute decrease in hematocrit of greater than 15%(when hemoglobin level was not available). The Minor bleeding was defined as: Observed blood loss and a decrease in hemoglobin level of 30 to 50 g/L (or, when hemoglobin level was not available, a decrease in the hematocrit of 9 to 15 percentage points) or a decrease in hemoglobin level of 40 g/L or greater (or ≥12% in hematocrit) if no bleeding site was identifiable. We also monitored for the occurrence of profound thrombocytopenia (\<20x103 platelets/μL) or need for transfusion of blood products.

Trial Locations

Locations (7)

The First People's Hospital of Shunde; 🇨🇳 Foshan, Guangdong, China

The Second People's Hospital of Foshan; 🇨🇳 Foshan, Guangdong, China

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China

Guangzhou Panyu Central Hospital; 🇨🇳 Guangzhou, Guangdong, China

Huadu District People's Hospital of Guangzhou; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Clinical Medicine of Guangdong Pharmaceutical University; 🇨🇳 Guangzhou, Guangdong, China

Qingyuan People's Hospital; 🇨🇳 Qingyuan, Guangdong, China