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

NCT03725800 | Unknown DMC

• 1 other identifier: GDREC2018419H
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 8

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.

Conditions

Antiplatelet Drug-related Gastrointestinal Injury

Keywords

coronary heart disease; mono-antiplatelet drug; antiplatelet-induced gastrointestinal injury symptom; medication adherence; prospective observational study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Bleeding Events

  1-1.5 years after PCI

• Conversion of Antiplatelet Drug

  1-1.5 years after PCI

• Discontinuation of Antiplatelet Drug

  1-1.5 years after PCI

• Health Economic Costs

  1-1.5 years after PCI

• Utilization Rate of GI Protection Drug

  1-1.5 years after PCI

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥18 years
• Currently alive at 1-1.5 years after PCI
• 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 \[ASIDE\])
• Provided written informed consent for this study.

You may not qualify if:

• Refusal to sign the informed consent form
• Acute coronary syndromes
• Cerebral thrombosis within 1 month or cerebral hemorrhage within 1 year
• Hematopathy or non-GI bleeding tendency
• Allergy to aspirin
• Severe uncontrolled hypertension (\>180/110 mmHg)
• Pregnancy or lactation
• Drug or alcohol abuse
• Malignant tumor or \<1-year life expectancy

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• The First Affiliated Hospital of Guangdong Pharmaceutical University: collaborator
• Guangzhou Panyu Central Hospital: collaborator
• First People's Hospital, Shunde China: collaborator
• Second People's Hospital of Foshan City: collaborator
• The First People's Hospital of Qingyuan: collaborator
• Zhongshan People's Hospital, Guangdong, China: collaborator
• Huadu District People's Hospital of Guangzhou: collaborator

Study Sites (8)

The First People's Hospital of Shunde

Foshan, Guangdong, 510000, China

Location

The Second People's Hospital of Foshan

Foshan, Guangdong, 510000, China

Location

Guangdong General Hospital

Guangzhou, Guangdong, 501080, China

Location

Guangzhou Panyu Central Hospital

Guangzhou, Guangdong, 510000, China

Location

Huadu District People's Hospital of Guangzhou

Guangzhou, Guangdong, 510000, China

Location

The First Affiliated Hospital of Clinical Medicine of Guangdong Pharmaceutical University

Guangzhou, Guangdong, 510000, China

Location

Guangdong General Hospital

Guangzhou, Guangdong, China

Location

Qingyuan People's Hospital

Qingyuan, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Coronary Disease; Medication Adherence

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Yong Liu, MD,PhD

  Guangdong Cardiovascular Institute,Guangdong General Hospital

  STUDY DIRECTOR

• Shiqun Chen, MS

  Guangdong Cardiovascular Institute,Guangdong General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 27, 2018
• First Posted: October 31, 2018
• Study Start: October 15, 2018
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

CN (8)