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NCT Number: NCT05567536

Long Term Follow-up of Comparison of Clopidogrel vs. Aspirin Monotherapy After Drug-eluting Stent Implantation

This is an retrospective extended study of a randomized clinical trial (The HOST-EXAM trial ClinicalTrials.gov Identifier: NCT02044250).

Investigators will perform a retrospective analysis of all participants enrolled in this trial will be performed, until the longest follow-up duration.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atheroscleroses, Coronary Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The HOST-EXAM trial (ClinicalTrials.gov Identifier: NCT02044250) was an randomized clinical trial that was performed to compare head-to-head, the efficacy and safety between aspirin and clopidogrel monotherapy in patients who received PCI for coronary artery disease and required chronic maintenance antiplatelet therapy. From March 2014 through May 2018, a total of 5438 patients were enrolled, and follow-up was performed upto 24 months after randomization. After this study, randomization was unlocked and patients were followed-up based on the standard protocol.

Afterwards, the current study was planned to perform a extended follow-up of the HOST-EXAM population. The specific drug by the randomization group in the HOST-EXAM trial was not mandatory after the initial 24 months, therefore participants received medication according to the current guidelines, and according to the physicians preferences.

This is a observational, retrospective analysis of all clinical events after the randomization period. The prescribed medications and any clinical events will be evaluated.

Who can participate

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

Inclusion criteria

  • Patients who were enrolled in the HOST-EXAM randomized clinical trial

Exclusion criteria

  • None, otherwise the patient refuses to participate in this study, or refuses to provide personal medical information

Treatment and study plan

Antiplatelet Agents

Drug

Patients who received a single antiplatelet agent will be analyzed according to the prescribed antiplatelet agent

Primary outcomes

  1. Patient oriented composite outcome

    Time frame: From date of randomization until March, 2022.

    A composite of all-cause death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and major bleeding complication

Secondary outcomes

  1. Thrombotic outcome

    Time frame: From date of randomization until March, 2022.

    cardiac death, non-fatal MI, ischemic stroke, readmission due to ACS, and definite or probable stent thrombosis

  2. Bleeding outcome

    Time frame: From date of randomization until March, 2022.

    Bleeding Academic Research Consortium (BARC) type ≥2 bleeding

Other outcomes

  1. All-cause death

    Time frame: From date of randomization until March, 2022.

    Death from any cause

  2. Cardiac death

    Time frame: From date of randomization until March, 2022.

    Death from a cardiac cause

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

HOST-EXAM-Ex : Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - EXtended Antiplatelet Monotherapy - EXtended Follow up

Acronym: HOST-EXAM-EX

Important dates

Study start
2014
Primary completion
2022
Study completion
2028
First posted
Oct 5, 2022
Registry last updated
Oct 5, 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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