Coronary Artery DiseaseHOST-EXAM-EXNCT05567536
Long Term Follow-up of Comparison of Clopidogrel vs. Aspirin Monotherapy After Drug-eluting Stent Implantation
An observational study of Coronary Artery Disease and Atheroscleroses, Coronary, run by Seoul National University Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Atheroscleroses, Coronary
- What is being tested?
- Antiplatelet Agents
- How many people
- 5,530 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2014to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
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.
Who may be able to join
- Patients who were enrolled in the HOST-EXAM randomized clinical trial
Who cannot join
- None, otherwise the patient refuses to participate in this study, or refuses to provide personal medical information
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease, Atheroscleroses, Coronary
- Being tested
- Antiplatelet Agents
- Keywords
- percutenous coronary intervention, drug-eluting stent, chronic maintenance period
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiplatelet AgentsDrug
Patients who received a single antiplatelet agent will be analyzed according to the prescribed antiplatelet agent
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel group | This group are those who received clopidogrel 75mg qd as a single antiplatelet agent therapy after PCI. Receives: Drug: Antiplatelet Agents | |
| Aspirin group | This group are those who received aspirin 100mg qd as a single antiplatelet agent therapy after PCI. Receives: Drug: Antiplatelet Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient oriented composite outcome
A composite of all-cause death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and major bleeding complication
Measured: From date of randomization until March, 2022.
Secondary outcomes (2)
Thrombotic outcome
cardiac death, non-fatal MI, ischemic stroke, readmission due to ACS, and definite or probable stent thrombosis
Measured: From date of randomization until March, 2022.
Bleeding outcome
Bleeding Academic Research Consortium (BARC) type ≥2 bleeding
Measured: From date of randomization until March, 2022.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start1 Mar 2014
- Primary completion1 Oct 2022 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Retrospective
- Enrolment
- 5,530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Soo Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567536
- Sponsor's protocol ID
- 1208-028-421
- Acronym
- HOST-EXAM-EX
- Status last verified
- Oct 2022
- First submitted
- 26 Sep 2022
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Koo BK, Kang J, Park KW, Rhee TM, Yang HM, Won KB, Rha SW, Bae JW, Lee NH, Hur SH, Yoon J, Park TH, Kim BS, Lim SW, Cho YH, Jeon DW, Kim SH, Han JK, Shin ES, Kim HS; HOST-EXAM investigators. Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention (HOST-EXAM): an investigator-initiated, prospective, randomised, open-label, multicentre trial. Lancet. 2021 Jun 26;397(10293):2487-2496. doi: 10.1016/S0140-6736(21)01063-1. Epub 2021 May 16.
PubMed 34010616Antithrombotic Trialists' (ATT) Collaboration; Baigent C, Blackwell L, Collins R, Emberson J, Godwin J, Peto R, Buring J, Hennekens C, Kearney P, Meade T, Patrono C, Roncaglioni MC, Zanchetti A. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet. 2009 May 30;373(9678):1849-60. doi: 10.1016/S0140-6736(09)60503-1.
PubMed 19482214
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOST-EXAM-Ex : Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - EXtended Antiplatelet Monotherapy - EXtended Follow up
- ClinicalTrials.gov ID
- NCT05567536
- Acronym / sponsor ID
- HOST-EXAM-EX / 1208-028-421
- Conditions
- Coronary Artery Disease, Atheroscleroses, Coronary
- Keywords
- percutenous coronary intervention, drug-eluting stent, chronic maintenance period
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,530 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Oct 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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel group | – | Drug: Antiplatelet AgentsThis group are those who received clopidogrel 75mg qd as a single antiplatelet agent therapy after PCI. |
| Aspirin group | – | Drug: Antiplatelet AgentsThis group are those who received aspirin 100mg qd as a single antiplatelet agent therapy after PCI. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients who were enrolled in the HOST-EXAM randomized clinical trial
Key exclusion criteria (1 listed)
- None, otherwise the patient refuses to participate in this study, or refuses to provide personal medical information
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 |
|---|---|---|
| Antiplatelet AgentsPatients who received a single antiplatelet agent will be analyzed according to the prescribed antiplatelet agent | Drug | Aspirin group, Clopidogrel group |
Primary outcome
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
2 secondary outcomes
Thrombotic outcome
Time frame: From date of randomization until March, 2022.
Bleeding outcome
Time frame: From date of randomization until March, 2022.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Results publication: PubMed 34010616Koo BK, Kang J, Park KW, Rhee TM, Yang HM, Won KB, Rha SW, Bae JW, Lee NH, Hur SH, Yoon J, Park TH, Kim BS, Lim SW, Cho YH, Jeon DW, Kim SH, Han JK, Shin ES, Kim HS; HOST-EXAM investigators. Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention (HOST-EXAM): an investigator-initiated, prospective, randomised, open-label, multicentre trial. Lancet. 2021 Jun 26;397(10293):2487-2496. doi: 10.1016/S0140-6736(21)01063-1. Epub 2021 May 16.
- Results publication: PubMed 19482214Antithrombotic Trialists' (ATT) Collaboration; Baigent C, Blackwell L, Collins R, Emberson J, Godwin J, Peto R, Buring J, Hennekens C, Kearney P, Meade T, Patrono C, Roncaglioni MC, Zanchetti A. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet. 2009 May 30;373(9678):1849-60. doi: 10.1016/S0140-6736(09)60503-1.
- Individual participant dataSharing planned: No. 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.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Atheroscleroses, Coronary, run by Seoul National University Hospital.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Patient oriented composite outcome (time frame: From date of randomization until March, 2022.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05567536, which also lists 2 linked publications.
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 5 Oct 2022.