An observational study in Antiplatelet Drug-related Gastrointestinal Injury, sponsored by Guangdong Provincial People's Hospital. Status unknown at 8 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-31.
Sponsored by Guangdong Provincial People's Hospital · Observational
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.
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.
Guangdong Provincial People's Hospital is the lead sponsor of 231 studies on the registry; 101 are open to participants now.
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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.
Exclusion Criteria:
Patients(aged ≥18 years) who have undergone PCI between 1 and 1.5 years, currently alive and is using aspirin for mono-antiplatelet therapy.
Patients(aged ≥18 years) who have undergone PCI between 1 and 1.5 years, currently alive and is using clopidogrel for mono-antiplatelet therapy.
Patients(aged ≥18 years) who have undergone PCI between 1 and 1.5 years, currently alive and is using ASIDE for mono-antiplatelet therapy.
Antiplatelet-induced Gastrointestinal Injury Symptom(AI-GIS)
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.
Time frame: 1 year after PCI
Bleeding Events
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.
Time frame: 1-1.5 years after PCI
Conversion of Antiplatelet Drug
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.
Time frame: 1-1.5 years after PCI
Discontinuation of Antiplatelet Drug
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.
Time frame: 1-1.5 years after PCI
Health Economic Costs
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.
Time frame: 1-1.5 years after PCI
Utilization Rate of GI Protection Drug
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.
Time frame: 1-1.5 years after PCI
Major Adverse Cardiovascular Events
All-cause mortality, target vessel revascularization, and non-fatal myocardial infarction (at 3 and 6 months)
Time frame: 1-1.5 years after PCI
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Guangdong Provincial People's Hospital