Antiplatelet Drug-related Gastrointestinal InjuryRESCIND-OCEANNCT03725800
Long-term MOno-Antiplatelet Drug Strategy After PerCutanEous CoronAry InterveNtion
An observational study of Antiplatelet Drug-related Gastrointestinal Injury, run by Guangdong Provincial People's Hospital at 8 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antiplatelet Drug-related Gastrointestinal Injury
- How many people
- 1,000 participants
- Where
- 8 sitesChina
- Study dates
- 15 Oct 2018to Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
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- Pregnancy or lactation
- Drug or alcohol abuse
- Malignant tumor or <1-year life expectancy
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
The First People's Hospital of Shunde
Foshan, Guangdong, 510000
The Second People's Hospital of Foshan
Foshan, Guangdong, 510000
Guangdong General Hospital
Guangzhou, Guangdong, 501080
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, 510000
Huadu District People's Hospital of Guangzhou
Guangzhou, Guangdong, 510000
The First Affiliated Hospital of Clinical Medicine of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510000
Guangdong General Hospital
Guangzhou, Guangdong
Qingyuan People's Hospital
Qingyuan, Guangdong, 510000
About this study
Official title: 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.
Read the 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.
- Keywords
- coronary heart disease, mono-antiplatelet drug, antiplatelet-induced gastrointestinal injury symptom, medication adherence, prospective observational study
- Medical subject headings
- Coronary Disease, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after PCI
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 1-1.5 years after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start15 Oct 2018
- Primary completionOct 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiplatelet Drug-related Gastrointestinal InjuryStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou Panyu Central Hospital, First People's Hospital, Shunde China, Second People's Hospital of Foshan City, The First People's Hospital of Qingyuan, Zhongshan People's Hospital, Guangdong, China, Huadu District People's Hospital of Guangzhou
- Responsible party
- Principal investigator, Liu yong, Guangdong Provincial People's Hospital
- Investigators
- Yong Liu, MD,PhD, Study director, Guangdong Cardiovascular Institute,Guangdong General HospitalShiqun Chen, MS, Study director, Guangdong Cardiovascular Institute,Guangdong General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725800
- Sponsor's protocol ID
- GDREC2018419H
- Acronym
- RESCIND-OCEAN
- Status last verified
- Oct 2018
- First submitted
- 27 Oct 2018
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03725800
- Acronym / sponsor ID
- RESCIND-OCEAN / GDREC2018419H
- Keywords
- coronary heart disease, mono-antiplatelet drug, antiplatelet-induced gastrointestinal injury symptom, medication adherence, prospective observational study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou Panyu Central Hospital, First People's Hospital, Shunde China, Second People's Hospital of Foshan City, The First People's Hospital of Qingyuan, Zhongshan People's Hospital, Guangdong, China, Huadu District People's Hospital of Guangzhou
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Antiplatelet-induced Gastrointestinal Injury Symptom(AI-GIS)
Time frame: 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.
6 secondary outcomes
Bleeding Events
Time frame: 1-1.5 years after PCI
Conversion of Antiplatelet Drug
Time frame: 1-1.5 years after PCI
Discontinuation of Antiplatelet Drug
Time frame: 1-1.5 years after PCI
Health Economic Costs
Time frame: 1-1.5 years after PCI
Utilization Rate of GI Protection Drug
Time frame: 1-1.5 years after PCI
Major Adverse Cardiovascular Events
Time frame: 1-1.5 years after PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
Related trials for Antiplatelet Drug-related Gastrointestinal Injury
Not yet recruitingObservational study
Gastrointestinal Bleeding is Blood Loss in the Digestive Tract, Classified as Upper or Lower. Ischemic Heart Disease is Due to Blocked Heart Arteries. Antiplatelet Drugs Help Prevent Heart Attacks But Increase GI Bleeding Risk, Especially When Used Together as Dual Therapy.
Gastro Intestinal Bleeding, Ischaemic Heart Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Liu, MD,PhD study director
Guangdong Cardiovascular Institute,Guangdong General Hospital
Shiqun Chen, MS study director
Guangdong Cardiovascular Institute,Guangdong General Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiplatelet Drug-related Gastrointestinal Injury, run by Guangdong Provincial People's Hospital at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antiplatelet-induced Gastrointestinal Injury Symptom(AI-GIS) (time frame: 1 year after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.