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

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

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.

Study Overview

• Status: Unknown
• Conditions: Antiplatelet Drug-related Gastrointestinal Injury

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China, 510000
      • The First People's Hospital of Shunde
    • Foshan, Guangdong, China, 510000
      • The Second People's Hospital of Foshan
    • Guangzhou, Guangdong, China
      • Guangdong General Hospital
    • Guangzhou, Guangdong, China, 510000
      • Huadu District People's Hospital of Guangzhou
    • Guangzhou, Guangdong, China, 501080
      • Guangdong General Hospital
    • Guangzhou, Guangdong, China, 510000
      • Guangzhou Panyu Central Hospital
    • Guangzhou, Guangdong, China, 510000
      • The First Affiliated Hospital of Clinical Medicine of Guangdong Pharmaceutical University
    • Qingyuan, Guangdong, China, 510000
      • Qingyuan People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year after PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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)	1-1.5 years after PCI

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Collaborators: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; Zhongshan People's Hospital, Guangdong, China; The First Affiliated Hospital of Guangdong Pharmaceutical University; Guangzhou Panyu Central Hospital; First People's Hospital, Shunde China; Huadu District People's Hospital of Guangzhou; Second People's Hospital of Foshan City; The First People's Hospital of Qingyuan
• Investigators: Study Director: Yong Liu, MD,PhD, Guangdong Cardiovascular Institute,Guangdong General Hospital; Study Director: Shiqun Chen, MS, Guangdong Cardiovascular Institute,Guangdong General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2018
• Primary Completion (ANTICIPATED): October 1, 2019
• Study Completion (ANTICIPATED): November 1, 2019

Study Registration Dates

• First Submitted: October 27, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (ACTUAL): October 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 30, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: medication adherence; coronary heart disease; prospective observational study; mono-antiplatelet drug; antiplatelet-induced gastrointestinal injury symptom
• Other Study ID Numbers: GDREC2018419H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No