Long Term Follow-up of Comparison of Clopidogrel vs. Aspirin Monotherapy After Drug-eluting Stent Implantation (HOST-EXAM-EX)

October 1, 2022 updated by: Hyo-Soo Kim, Seoul National University Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

5530

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who were enrolled in the HOST-EXAM randomized clinical trial will be analyzed for an extended follow-up duration.

Patients enrolled in the HOST-EXAM trial were patients that received stenting with a drug-eluting stent and had successfully completed 6-18 months of DAPT without events.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Clopidogrel group
This group are those who received clopidogrel 75mg qd as a single antiplatelet agent therapy after PCI.
Drug: Antiplatelet Agents
Patients who received a single antiplatelet agent will be analyzed according to the prescribed antiplatelet agent
Aspirin group
This group are those who received aspirin 100mg qd as a single antiplatelet agent therapy after PCI.
Drug: Antiplatelet Agents
Patients who received a single antiplatelet agent will be analyzed according to the prescribed antiplatelet agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of randomization until March, 2022.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of randomization until March, 2022.
Bleeding outcome
Time Frame: From date of randomization until March, 2022.
Bleeding Academic Research Consortium (BARC) type ≥2 bleeding
From date of randomization until March, 2022.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death
Time Frame: From date of randomization until March, 2022.
Death from any cause
From date of randomization until March, 2022.
Cardiac death
Time Frame: From date of randomization until March, 2022.
Death from a cardiac cause
From date of randomization until March, 2022.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

December 31, 2028

Study Registration Dates

First Submitted

September 26, 2022

First Submitted That Met QC Criteria

October 1, 2022

First Posted (Actual)

October 5, 2022

Study Record Updates

Last Update Posted (Actual)

October 5, 2022

Last Update Submitted That Met QC Criteria

October 1, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1208-028-421

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The HOST-EXAM-Ex study is planning to continue follow-up until 2028. No individual participant data will be available before this. Any relevant inquiries should be sent to the central contact person or backup person.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Antiplatelet Agents

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe