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Completed

NCT Number: NCT05487560

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

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.

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Key information

Conditions

Acute Coronary Syndrome or B Cerebral Infarction Requiring DAPT(Clopidogrel + Aspirin) for at Least 6 Months Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hanmi Pharmaceutical Company Limited

Seoul, 05545, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patients for whom use of Esomezol Cap is prohibited

Treatment and study plan

Esomezol Cap

Drug

Esomezol Cap, Once daily administered per the locally approved product information

Primary outcomes

  1. The incidence of total Major Adverse CardioCerebrovascular Events(MACCE) from baseline

    Time frame: 6 months

Secondary outcomes

  1. The incidence of MACCE by each of the following constituent variables

    Time frame: 6 months

    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

  2. The incidence e of Major bleeding

    Time frame: 6 months

    Major bleeding: intracranial hemorrhage, bleeding requiring a transfusion or A decrease in hemoglobin level ≥ 5 g/dL or a decrease in hematocrit ≥ 15%

  3. The incidence of Minor bleeding

    Time frame: 6 months

    Minor bleeding: Any bleeding other than major bleeding

  4. The incidence of GI Bleeding

    Time frame: 6 months

    GI Bleeding: hematemesis, melena/hematochezia, Fecal Occult Blood Test, FOBT

  5. Occurrence and aspect of adverse events(AEs)

    Time frame: 6 months

  6. Medication compliance evaluation

    Time frame: 6 months

  7. Drug administration dose of DAPT(Clopidogrel + Aspirin) and Esomezol Cap

    Time frame: baseline

  8. 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

  9. Add-on drugs for the treatment of patients with acute coronary syndrome or cerebral infarction

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 4, 2022
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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