Acute Coronary Syndrome or B Cerebral Infarction Requiring DAPT(Clopidogrel + Aspirin) for at Least 6 MonthsNCT05487560
An Observational Study to Evaluate the Incidence of MACCE According to Time Interval of Taking Medication in Patients With Acute Coronary Syndrome or Cerebral Infarction Who Received DAPT for the Secondary Prevention and Esomezol Cap for the Prevention of Gastrointestinal Bleeding
An observational study of Acute Coronary Syndrome or B Cerebral Infarction Requiring DAPT(Clopidogrel + Aspirin) for at Least 6 Months, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
This study is to evaluate the incidence rate of Major Adverse CardioCerebrovascular Events(MACCE) in Patients with Acute Coronary Syndrome or Cerebral Infarction Who Received DAPT for the secondary prevention and Esomezol Cap for the prevention of gastrointestinal bleeding. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Coronary Syndrome or B Cerebral Infarction Requiring DAPT(Clopidogrel + Aspirin) for at Least 6 Months
- What is being tested?
- Esomezol Cap
- How many people
- 4,133 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Apr 2019to 22 Jun 2022
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute Coronary Syndrome or B Cerebral Infarction requiring DAPT (Clopidogrel + Aspirin) for at least 6 months
Who may be able to join
- Age≥19
- Among patients who visited the hospital due to the onset or recurrence of acute coronary syndrome or cerebral infarction within 1 month prior to registration, patients who are expected to receive DAPT(Clopidogrel + Aspirin) for at least 6 months, in combination with Esomezol Cap for the purpose of preventing gastrointestinal bleeding Patients receiving or planning to receive treatment
- Subject who can written informed consent voluntarily
Who cannot join
- 1) Patients for whom use of Esomezol Cap is prohibited
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Prospective Cohort, Observational Study to Evaluate the Incidence of Major Adverse Cardiocerebrovascular Events According to Time Interval of Taking Medication in Patients With Acute Coronary Syndrome or Cerebral Infarction Who Received Dual AntiPlatelet Therapy (DAPT) for the Secondary Prevention and Esomezol Cap for the Prevention of Gastrointestinal Bleeding
This study is to evaluate the incidence rate of Major Adverse CardioCerebrovascular Events(MACCE) in Patients with Acute Coronary Syndrome or Cerebral Infarction Who Received DAPT for the secondary prevention and Esomezol Cap for the prevention of gastrointestinal bleeding.
Read the detailed description
This study was a multi-center, prospective, non-interventional, observational study of administering Esomezol Cap for the purpose of preventing gastrointestinal bleeding.
Data was collected from patients receiving routine treatment at hospitals in South Korea. Each patient visited the institution according to the protocol that designed the follow-up visits for six months to examine the safety of Esomezol Cap.
This study approved by the institutions' IRBs and was conducted in compliance with clinical research ethics regulations.
- Being tested
- Esomezol Cap
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomezol CapDrug
Esomezol Cap, Once daily administered per the locally approved product information
| Study group | Role | What they receive |
|---|---|---|
| 12-hour interval group (No interventional) | DAPT(Clopidogrel + Aspirin) and Esomezol Cap taken every 12 hours Receives: Drug: Esomezol Cap | |
| co-administration group (No interventional) | Taking DAPT(Clopidogrel + Aspirin) and Esomezol Cap at the same time Receives: Drug: Esomezol Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of total Major Adverse CardioCerebrovascular Events(MACCE) from baseline
Measured: 6 months
Secondary outcomes (9)
The incidence of MACCE by each of the following constituent variables
MACCE: Death due to cardiovascular abnormalities, myocardial infarction, stroke (ischemic or hemorrhagic), Target vessel reperfusion (in case of repeated intervention or coronary artery bypass surgery), All other cardiovascular events requiring hospitalization
Measured: 6 months
The incidence e of Major bleeding
Major bleeding: intracranial hemorrhage, bleeding requiring a transfusion or A decrease in hemoglobin level ≥ 5 g/dL or a decrease in hematocrit ≥ 15%
Measured: 6 months
The incidence of Minor bleeding
Minor bleeding: Any bleeding other than major bleeding
Measured: 6 months
The incidence of GI Bleeding
GI Bleeding: hematemesis, melena/hematochezia, Fecal Occult Blood Test, FOBT
Measured: 6 months
Occurrence and aspect of adverse events(AEs)
Measured: 6 months
Medication compliance evaluation
Measured: 6 months
Drug administration dose of DAPT(Clopidogrel + Aspirin) and Esomezol Cap
Measured: baseline
Drugs that are prescribed in combination other than DAPT(Clopidogrel + Aspirin) and Esomezol Cap for the treatment of patients with acute coronary syndrome or cerebral infarction
Measured: baseline
Add-on drugs for the treatment of patients with acute coronary syndrome or cerebral infarction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start18 Apr 2019
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndrome or B Cerebral Infarction Requiring DAPT(Clopidogrel + Aspirin) for at Least 6 MonthsStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe 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
- 4,133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487560
- Sponsor's protocol ID
- HM-ESO-OS-01
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective Cohort, Observational Study to Evaluate the Incidence of Major Adverse Cardiocerebrovascular Events According to Time Interval of Taking Medication in Patients With Acute Coronary Syndrome or Cerebral Infarction Who Received Dual AntiPlatelet Therapy (DAPT) for the Secondary Prevention and Esomezol Cap for the Prevention of Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT05487560
- Acronym / sponsor ID
- HM-ESO-OS-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,133 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 4 Aug 2022 (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.
This study is to evaluate the incidence rate of Major Adverse CardioCerebrovascular Events(MACCE) in Patients with Acute Coronary Syndrome or Cerebral Infarction Who Received DAPT for the secondary prevention and Esomezol Cap for the prevention of gastrointestinal bleeding.
Detailed description
This study was a multi-center, prospective, non-interventional, observational study of administering Esomezol Cap for the purpose of preventing gastrointestinal bleeding.
Data was collected from patients receiving routine treatment at hospitals in South Korea. Each patient visited the institution according to the protocol that designed the follow-up visits for six months to examine the safety of Esomezol Cap.
This study approved by the institutions' IRBs and was conducted in compliance with clinical research ethics regulations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12-hour interval group (No interventional) | – | Drug: Esomezol CapDAPT(Clopidogrel + Aspirin) and Esomezol Cap taken every 12 hours |
| co-administration group (No interventional) | – | Drug: Esomezol CapTaking DAPT(Clopidogrel + Aspirin) and Esomezol Cap at the same time |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute Coronary Syndrome or B Cerebral Infarction requiring DAPT (Clopidogrel + Aspirin) for at least 6 months
Key inclusion criteria (3 listed)
- Age≥19
- Among patients who visited the hospital due to the onset or recurrence of acute coronary syndrome or cerebral infarction within 1 month prior to registration, patients who are expected to receive DAPT(Clopidogrel + Aspirin) for at least 6 months, in combination with Esomezol Cap for the purpose of preventing gastrointestinal bleeding Patients receiving or planning to receive treatment
- Subject who can written informed consent voluntarily
Key exclusion criteria (1 listed)
- 1) Patients for whom use of Esomezol Cap is prohibited
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esomezol CapEsomezol Cap, Once daily administered per the locally approved product information | Drug | 12-hour interval group (No interventional), co-administration group (No interventional) |
Primary outcome
The incidence of total Major Adverse CardioCerebrovascular Events(MACCE) from baseline
Time frame: 6 months
9 secondary outcomes
The incidence of MACCE by each of the following constituent variables
Time frame: 6 months
The incidence e of Major bleeding
Time frame: 6 months
The incidence of Minor bleeding
Time frame: 6 months
The incidence of GI Bleeding
Time frame: 6 months
Occurrence and aspect of adverse events(AEs)
Time frame: 6 months
Medication compliance evaluation
Time frame: 6 months
Drug administration dose of DAPT(Clopidogrel + Aspirin) and Esomezol Cap
Time frame: baseline
Drugs that are prescribed in combination other than DAPT(Clopidogrel + Aspirin) and Esomezol Cap for the treatment of patients with acute coronary syndrome or cerebral infarction
Time frame: baseline
Add-on drugs for the treatment of patients with acute coronary syndrome or cerebral infarction
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome or B Cerebral Infarction Requiring DAPT(Clopidogrel + Aspirin) for at Least 6 Months, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence of total Major Adverse CardioCerebrovascular Events(MACCE) from baseline (time frame: 6 months). 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 4 Aug 2022.