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

NCT ID: NCT05567536

Last Updated: 2022-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

5530 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-01

Study Completion Date

2028-12-31

Brief Summary

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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

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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

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Coronary Artery Disease Atheroscleroses, Coronary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Clopidogrel group

This group are those who received clopidogrel 75mg qd as a single antiplatelet agent therapy after PCI.

Antiplatelet Agents

Intervention Type DRUG

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.

Antiplatelet Agents

Intervention Type DRUG

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

Interventions

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Antiplatelet Agents

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Soo Kim

Professor, Department of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type RESULT
PMID: 34010616 (View on PubMed)

Antithrombotic 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.

Reference Type RESULT
PMID: 19482214 (View on PubMed)

Other Identifiers

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1208-028-421

Identifier Type: -

Identifier Source: org_study_id

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